Latest news with #JulioRosenstock
Medscape
8 hours ago
- Health
- Medscape
Orforglipron Lowers A1c, Weight in Early Type 2 Diabetes
CHICAGO — The investigational non-peptide small-molecule oral GLP-1 agonist orforglipron significantly reduced A1c over 40 weeks in adults with early type 2 diabetes, according to the results of ACHIEVE-1 sponsored by Eli Lilly. In the trial, orforglipron reduced A1c to the 6.5% range and produced clinically meaningful weight loss with a safety profile similar to that of other GLP-1 drugs. ACHIEVE-1 is the first of seven phase 3 studies of the safety and efficacy of the drug in over 6000 patients with type 2 diabetes and obesity, Orforglipron and other similar non-peptide small molecules "have the potential to be widely accepted as a much earlier therapy for type 2 diabetes," Julio Rosenstock, MD, senior scientific advisor for Velocity Clinical Research and clinical professor of medicine at the University of Texas Southwestern Medical Center, Dallas, said at a press briefing here at the American Diabetes Association (ADA) 85th Scientific Sessions. The findings were simultaneously published in the New England Journal of Medicine . Orforglipron is a once-daily non-peptide small molecule that can be taken any time of day without restrictions on meals or water intake. This contrasts with the currently approved oral GLP-1 receptor agonist semaglutide (Rybelsus, Novo Nordisk), a peptide that ideally should be taken while fasting and with no food or water for at least 30 minutes after ingestion to prevent degradation. Lilly is the farthest along in the development of a small-molecule non-peptide GLP-1 agonist, but at least two others are in phase 3 trials, including CX11 (also known as VCT220) from Corxel Pharmaceuticals and HRS-7535 from Jiangsu Hengrui Pharmaceuticals and Kailera Therapeutics. Several more are in phase 2 trials. As a class, the oral non-peptide small-molecule GLP-1 receptor agonists "have the potential to open the access for more people because they're easier to take, they're simpler to produce, and in theory, they should be less expensive. So you can see the potential for these drugs," Rosenstock said. However, Amy E. Rothberg, MD, clinical professor of internal medicine and of nutritional sciences at the University of Michigan, Ann Arbor, told Medscape Medical News that she's concerned because, unlike injectable GLP-1 receptor agonists, "most oral medications are metabolized by the liver. The enzymes that metabolize them may be affected by people's weight. Therefore, if you have obesity, the distribution and the kinetics of the drug may be different than someone who is normal weight. Also, if someone loses weight from having a higher BMI to a lower weight, that may affect the drug distribution and the drug bioavailability." She believes that "the companies need to look at drug exposure before and after weight loss because efficacy and safety could be affected by weight change." First Phase 3 Orforglipron Data Meets Endpoints In ACHEIVE-1, 559 participants with early (duration range, 4.0-5.1 years) type 2 diabetes with A1c levels of 7.0%-9.5% (mean 8.0%) using only diet and exercise and a BMI 23.0 kg/m2 or greater, were randomized equally to receive orforglipron 3 mg, 12 mg, or 36 mg, or placebo once daily for 40 weeks. The primary endpoint, percentage-point change in A1c from baseline to week 40, showed reductions of 1.24, 1.47, 1.48 for the 3-mg, 12-mg, and 36-mg doses, respectively, compared with a 0.41 percentage-point reduction with placebo. All three orforglipron doses produced significant A1c reductions compared with placebo ( P < .001 for all comparisons). At week 40, the mean A1c level ranged from 6.5% to 6.7% with orforglipron, Rosenstock reported. Percentage of body weight losses from baseline to week 40 were 4.5%, 5.8%, and 7.6% for the 3-mg, 12-mg, and 36-mg doses, respectively, versus 1.7% with placebo. The most common adverse events were mild-to-moderate gastrointestinal events, most of which occurred during dose escalation. Gastrointestinal events leading to drug discontinuation occurred in 2.8%, 2.2%, and 5.7% of patients, respectively, for the three orforglipron doses, versus none with placebo. This was similar to what has been observed with other oral and injected GLP-1 agonists, Rosenstock said. "We did not see any surprises. You're going to see the same ranges of nausea and vomiting as with semaglutide and tirzepatide." There were no episodes of severe hypoglycemia. The overall proportions discontinuing permanently due to adverse events ranged from 4% to 8% with orforglipron versus 1% with placebo. "A Remarkable Scientific Achievement" Asked to comment, Simeon Taylor, MD, PhD, professor of medicine and director of the Institutional Research Training Program in Diabetes & Obesity at the University of Maryland School of Medicine, Baltimore, told Medscape Medical News : "This landmark scientific achievement ushers in a new chapter in the development of GLP-1 agonists." Taylor pointed out that "orforglipron's glycemic efficacy is only slightly less than monotherapy with Ozempic" and that it "has somewhat more placebo-subtracted weight loss efficacy in people with type 2 diabetes" than Ozempic. Overall, he said, "It is a remarkable scientific achievement to have developed a first-in-class orally bioavailable organic chemical entity with efficacy comparable to a third-generation injectable peptide drug. It is likely that many people with type 2 diabetes will be attracted to the option of an orally bioavailable drug." The other four ACHIEVE trials, to be reported later in 2025, will examine orforglipron in combination with metformin versus dapagliflozin (ACHIEVE-2), in combination with metformin compared to oral semaglutide (ACHIEVE-3), combined with multiple therapies versus insulin glargine (ACHIEVE-4), and in combination with insulin versus placebo (ACHIEVE-5). Another Lilly phase 3 trial, ATTAIN, is evaluating orforglipron for weight management. Results from ATTAIN-1 and ATTAIN-2 will also be presented later in 2025. "Lilly remains on track to submit orforglipron for weight management to global regulatory agencies by the end of this year and for the treatment of type 2 diabetes in 2026," according to a company statement. Rosenstock has reported receiving research/grant support from, serving on advisory boards for, and/or receiving consulting fees/honoraria from Applied Therapeutics, AstraZeneca, Biomea Fusion, Boehringer Ingelheim, Corcept, Eli Lilly, Hanmi, Merck, Novartis, Novo Nordisk, Oramed, Pfizer, Regeneron, Regor, Roche, Sanofi, Structure Therapeutics, and Terns. Taylor has reported receiving payments from the National Institute of Diabetes and Digestive and Kidney Diseases for an inventor's share of a patent covering metreleptin as a treatment for generalized lipodystrophy. He was employed by Eli Lilly in 2000-2002 and Bristol Myers Squibb in 2002-2013.
Malaysian Reserve
12 hours ago
- Health
- Malaysian Reserve
Lilly's oral GLP-1, orforglipron, showed compelling efficacy and a safety profile consistent with injectable GLP-1 medicines, in complete Phase 3 results published in The New England Journal of Medici
The investigational once-daily pill lowered A1C by an average of 1.3% to 1.6% across doses, with improvements seen as early as four weeks, in adults with type 2 diabetes In ACHIEVE-1, orforglipron also led to an average weight loss of 16.0 lbs (7.9%) at the highest dose by week 40 in a key secondary endpoint The safety profile of orforglipron was consistent with the established GLP-1 class INDIANAPOLIS, June 21, 2025 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) today announced detailed results from ACHIEVE-1, a Phase 3 trial evaluating the safety and efficacy of orforglipron compared to placebo in adults with type 2 diabetes and inadequate glycemic control with diet and exercise alone. Orforglipron is the first oral small molecule (non-peptide) glucagon-like peptide-1 (GLP-1) receptor agonist, taken without food and water restrictions, to successfully complete a Phase 3 trial. At 40 weeks, all three doses (3 mg, 12 mg, 36 mg) of orforglipron achieved the primary endpoint of superior A1C reduction. In addition, the 12 mg and 36 mg doses showed clinically meaningful and statistically significant reductions in body weight vs. placebo. In the study, orforglipron had a safety profile similar to the established GLP-1 class, and the most frequently reported adverse events were gastrointestinal-related. The results were presented at the American Diabetes Association (ADA) 85th Scientific Sessions 2025 and simultaneously published in The New England Journal of Medicine. In the study, orforglipron met the primary endpoint of superior A1C reduction compared to placebo at 40 weeks, lowering A1C by 1.3% to 1.6% from a baseline of 8.0%, for the efficacy estimand.1 In key secondary endpoints, up to 76.2% of participants taking orforglipron achieved the ADA treatment target A1C of <7%, 66.0% achieved an A1C of ≤6.5%, and 25.8% achieved <5.7%, defined as a normal A1C value.2,3 Improvements in A1C were observed as early as four weeks and were accompanied by similar reductions in fasting serum glucose. In another key secondary endpoint, participants taking the highest dose of orforglipron lost an average of 16.0 lbs (7.9%). While participants in ACHIEVE-1 did not appear to reach a weight plateau, longer-duration trials, such as the ATTAIN trials, will provide a comprehensive evaluation of the safety and efficacy of orforglipron for the treatment of obesity. 'The ACHIEVE-1 trial demonstrated that orforglipron, a novel oral small-molecule GLP-1, achieved clinically meaningful reductions in A1C and body weight over 40 weeks in adults with type 2 diabetes,' said Dr. Julio Rosenstock, senior scientific advisor for Velocity Clinical Research at Medical City Dallas, clinical professor of medicine, University of Texas Southwestern Medical Center, and lead trial investigator. 'The early onset of glycemic improvement, observed as soon as four weeks, reinforces the therapeutic potential of orforglipron as an effective, oral GLP-1 therapy for early type 2 diabetes treatment. These findings support further investigation in broader populations and longer-duration studies.' Full Results Orforglipron 3 mg Orforglipron 12 mg Orforglipron 36 mg Placebo Primary Endpoint A1C reduction from baseline of 8.0 %i Efficacy estimand 1.3 % 1.6 % 1.5 % 0.1 % Treatment-regimen estimand4 1.2 % 1.5 % 1.5 % 0.4 % Key Secondary Endpointsii Percent weight reduction from baseline of 90.2 kg (198.9 lbs)i,iii Efficacy estimand 4.7 % 6.1 % 7.9 % 1.6 % Treatment-regimen estimand 4.5 % 5.8 % 7.6 % 1.7 % Weight reduction from baseline of 90.2 kg (198.9 lbs)i,iii Efficacy estimand 4.4 kg (9.7 lbs) 5.5 kg (12.2 lbs) 7.3 kg (16.0 lbs) 1.3 kg (2.9 lbs) Treatment-regimen estimand 4.2 kg (9.3 lbs) 5.2 kg (11.5 lbs) 7.2 kg (15.8 lbs) 1.5 kg (3.4 lbs) Percent of participants achieving A1C <7 %i Efficacy estimand 72.9 % 76.2 % 74.9 % 28.0 % Treatment-regimen estimand 68.1 % 72.9 % 72.7 % 33.0 % Percent of participants achieving A1C ≤6.5 %i,ii Efficacy estimand 61.5 % 62.3 % 66.0 % 13.5 % Treatment-regimen estimand 56.9 % 58.1 % 61.9 % 14.9 % Percent of participants achieving A1C <5.7 %iii Efficacy estimand 17.7 % 25.8 % 23.9 % 3.8 % Treatment-regimen estimand 16.8 % 23.9 % 21.5 % 3.8 % Fasting serum glucose reduction from baseline of 147.5 mg/dLi Efficacy estimand 30.6 mg/dL 37.4 mg/dL 37.8 mg/dL 1.1 mg/dL Treatment-regimen estimand 30.7 mg/dL 36.5 mg/dL 34.7 mg/dL 10.8 mg/dL iSuperiority test was adjusted for from the full list of key secondary endpoints are available in the of participants achieving A1C <5.7% across all orforglipron doses and body weight for orforglipron 3 mg were not controlled for Type 1 error. 'This convenient once-daily pill with no restrictions on food and water intake could be an option for millions of people with type 2 diabetes who prefer oral medications over injectables,' said Jeff Emmick, M.D., Ph.D., senior vice president of product development at Lilly. 'The positive ACHIEVE-1 results position orforglipron as a potential treatment option with meaningful A1C and weight reduction, and a safety profile similar to injectable GLP-1 therapies. We look forward to the four remaining global readouts from the ACHIEVE program, as well as results of the ATTAIN program in obesity, and working with regulators to bring this once-daily oral GLP-1 to people around the world.' The overall safety profile of orforglipron in ACHIEVE-1 was consistent with the established GLP-1 class. The most common adverse events for participants treated with orforglipron (3 mg, 12 mg and 36 mg, respectively) were diarrhea (19%, 21% and 26%) vs. 9% with placebo, nausea (13%, 18% and 16%) vs. 2% with placebo, dyspepsia (11%, 20% and 15%) vs. 7% with placebo, constipation (8%, 17% and 14%) vs. 4% with placebo, and vomiting (5%, 7% and 14%) vs. 1% with placebo. These gastrointestinal-related adverse events were generally mild-to-moderate in severity and occurred primarily during dose escalation. Overall treatment discontinuation rates due to adverse events were 6% (3 mg), 4% (12 mg) and 8% (36 mg) for orforglipron vs. 1% with placebo. No hepatic safety signal was observed. Later this year, Lilly expects to share topline results from ACHIEVE-2, evaluating orforglipron compared with dapagliflozin, and ACHIEVE-3, evaluating orforglipron compared to oral semaglutide, both in adults with type 2 diabetes inadequately controlled with metformin. ATTAIN-1 and ATTAIN-2, evaluating orforglipron for weight management, will also be shared in the third quarter of this year. Lilly remains on track to submit orforglipron for weight management to global regulatory agencies by the end of this year and for the treatment of type 2 diabetes in 2026. About orforglipron Orforglipron (or-for-GLIP-ron) is an investigational, once-daily small molecule (non-peptide) oral glucagon-like peptide-1 receptor agonist that can be taken any time of the day without restrictions on food and water intake.5 Orforglipron was discovered by Chugai Pharmaceutical Co., Ltd. and licensed by Lilly in 2018. Chugai and Lilly published the preclinical pharmacology data of this molecule together.6 Lilly is running Phase 3 studies on orforglipron for the treatment of type 2 diabetes and for weight management in adults with obesity or overweight with at least one weight-related medical problem. It is also being studied as a potential treatment for obstructive sleep apnea and hypertension in adults with obesity. About ACHIEVE-1 and the ACHIEVE clinical trial program ACHIEVE-1 (NCT05971940) is a Phase 3, 40-week, randomized, double-blind, placebo-controlled trial comparing the efficacy and safety of orforglipron 3 mg, 12 mg and 36 mg as monotherapy to placebo in adults with type 2 diabetes and inadequate glycemic control with diet and exercise alone. The trial randomized 559 participants across the U.S., China, India, Japan and Mexico in 1:1:1:1 ratio to receive either 3 mg, 12 mg or 36 mg orforglipron or placebo. The primary objective of the study was to demonstrate that orforglipron (3 mg, 12 mg, 36 mg) is superior in A1C reduction from baseline after 40 weeks, compared to placebo, in people with type 2 diabetes who have not taken any anti-diabetic medications for at least 90 days prior to visit 1, and are naïve to insulin therapy. Study participants had a HbA1c between ≥7.0% and ≤9.5% and a BMI of ≥23 kg/m2. All participants in the orforglipron treatment arms started the study at a dose of orforglipron 1 mg once-daily and then increased the dose in a step-wise approach at four-week intervals to their final randomized maintenance dose of 3 mg (via a 1 mg step), 12 mg (via steps at 1 mg, 3 mg and 6 mg) or 36 mg (via steps at 1 mg, 3 mg, 6 mg, 12 mg and 24 mg). Flexible dosing was not permitted. The ACHIEVE Phase 3 global clinical development program for orforglipron has enrolled more than 6,000 people with type 2 diabetes across five global registration trials. The program began in 2023 with results anticipated later this year and into 2026. About LillyLilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit and or follow us on Facebook, Instagram and LinkedIn. P-LLY The efficacy estimand represents the treatment effect had on all participants who adhered to the study drug (with possible dose interruptions) for 40 weeks without initiating additional antihyperglycemic medications (>14 days of use). American Diabetes Association. Standards of Care in Diabetes—2020 Abridged for Primary Care Providers. Clinical Diabetes 2020; 38(1):10–38. Percent of participants achieving A1C <5.7% across all doses was not controlled for Type 1 error. The treatment-regimen estimand represents the estimated average treatment effect regardless of treatment discontinuation or initiation of additional antihyperglycemic medications. Ma X, Liu R, Pratt EJ, Benson CT, Bhattachar SN, Sloop KW. Effect of Food Consumption on the Pharmacokinetics, Safety, and Tolerability of Once-Daily Orally Administered Orforglipron (LY3502970), a Non-peptide GLP-1 Receptor Agonist. Diabetes Ther. 2024 Apr;15(4):819-832. Epub 2024 Feb 24. PMID: 38402332; PMCID: PMC10951152. T. Kawai, B. Sun, H. Yoshino, D. Feng, Y. Suzuki, M. Fukazawa, S. Nagao, D.B. Wainscott, A.D. Showalter, B.A. Droz, T.S. Kobilka, M.P. Coghlan, F.S. Willard, Y. Kawabe, B.K. Kobilka, & K.W. Sloop, Structural basis for GLP-1 receptor activation by LY3502970, an orally active nonpeptide agonist, Proc. Natl. Acad. Sci. U.S.A. 117 (47) 29959-29967, (2020). Cautionary Statement Regarding Forward-Looking Statements This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about orforglipron as a potential treatment for adults with type 2 diabetes, and the timeline for future readouts, presentations, and other milestones relating to orforglipron and its clinical trials and reflects Lilly's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there is no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with study results to date, that orforglipron will prove to be a safe and effective treatment for type 2 diabetes, that orforglipron will receive regulatory approval, or that Lilly will execute its strategy as expected. For further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release. Trademarks and Trade Names All trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are referenced in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company's or their rights thereto. We do not intend the use or display of other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies. Refer to: Brooke Frost; 317-432-9145 (Media) Michael Czapar; czapar_michael_c@ 317-617-0983 (Investors)
Yahoo
29-05-2025
- Business
- Yahoo
Lilly announces details of presentations at American Diabetes Association's (ADA) 85th Scientific Sessions
INDIANAPOLIS, May 29, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that data from studies of orforglipron, insulin efsitora alfa, tirzepatide (Zepbound and Mounjaro), retatrutide, eloralintide and bimagrumab will be presented at the American Diabetes Association's (ADA) 85th Scientific Sessions taking place June 20-23 in Chicago. Lilly will also host an investor event to highlight the company's cardiometabolic health portfolio and discuss key presentations from the ADA Scientific Sessions. The event will be held on Sunday, June 22 at 6:30 p.m. CDT and will be accessible via a live webcast on the "Webcasts & Presentations" section of Lilly's investor website. A replay will be available on the website following the event. Presentation HighlightsOrforglipron (investigational small molecule GLP-1 receptor agonist):In an ADA-sponsored symposium, Lilly will share results from the ACHIEVE-1 Phase 3 trial, which evaluated the safety and efficacy of orforglipron in adults with type 2 diabetes and inadequate glycemic control with diet and exercise alone. Insulin efsitora alfa (investigational once-weekly basal insulin):In another ADA-sponsored symposium, Lilly will share results from the QWINT-1, QWINT-3 and QWINT-4 Phase 3 trials, which evaluated once-weekly efsitora in adults with type 2 diabetes. Bimagrumab (investigational activin pathway inhibitor):In a third ADA-sponsored symposium, Lilly will share results from the BELIEVE Phase 2b trial, which evaluated bimagrumab alone and in combination with semaglutide in adults with overweight or obesity without type 2 diabetes. A selection of abstract titles and presentation details are listed below: Orforglipron (investigational small molecule GLP-1 receptor agonist):Presentation Title: Emerging Non-Peptide, Small Molecule GLP-1 Receptor Agonists—Can They Become Players?Presentation Date & Time: Saturday, June 21, 8 to 9:30 a.m. CDT Location: W375 APresenter: Julio Rosenstock, MD Insulin efsitora alfa (investigational once-weekly basal insulin):Presentation Title: Advancing and Facilitating Basal Insulin Therapy in Type 2 Diabetes—Breaking News on the QWINT 1, 3, and 4 Trials with Once-Weekly Insulin Efsitora Alfa!Presentation Date & Time: Sunday, June 22, 1:30 to 3 p.m. CDTLocation: W375 APresenter: Julio Rosenstock, MD; Richard M. Bergenstal, MD; Athena Philis-Tsimikas, MD; Thomas Blevins, MD; Chantal Mathieu, MD, PhD Tirzepatide (Zepbound and Mounjaro):Presentation Title: Association of Tirzepatide with Kidney Parameters in People with Obesity and Prediabetes from SURMOUNT-1 over 176 WeeksAbstract Number: 103-ORPresentation Date & Time: Friday, June 20, 5:30 to 6:30 p.m. CDTLocation: W185 A-DPresenter: Dr. Hiddo L. Heerspink, PhD Presentation Title: Sustained Weight Reduction by Thresholds in Adults with Obesity and Prediabetes Treated with Tirzepatide over 176 Weeks (SURMOUNT-1)Abstract Number: 144-ORPresentation Date & Time: Friday, June 20, 5:30 to 6:30 p.m. CDTLocation: W196 BCPresenter: Jamy D. Ard, MD Presentation Title: SURMOUNT-5 Tirzepatide vs. Semaglutide for Obesity—Rapid Responders and Associated Weight Reduction and SafetyAbstract Number: 224-ORPresentation Date & Time: Saturday, June 21, 4:30 to 6 p.m. CDTLocation: W181 A-CPresenter: Louis Aronne, MD, FACP, DABOM Presentation Title: Switching from Dulaglutide to Tirzepatide in T2D—Subgroup Analyses of the SURPASS-SWITCH TrialAbstract Number: 226-ORPresentation Date & Time: Saturday, June 21, 4:30 to 6:00 p.m. CDTLocation: W181 A-CPresenter: Anita Kwan, MSc Presentation Title: Patient-Reported Outcomes in People with T2D in the SURPASS-SWITCH Phase 4 Clinical TrialAbstract Number: 227-ORPresentation Date & Time: Saturday, June 21, 4:30 to 6:00 p.m. CDTLocation: W181 A-CPresenter: Kristina Boye, PhD Retatrutide (investigational GIP/GLP-1/glucagon receptor agonist):Presentation Title: Comparative Metabolic Effects of Semaglutide, Tirzepatide, and Retatrutide in a Monogenic (db/db) Mouse Model of ObesityAbstract Number: 2169-LBPresentation Date & Time: Sunday, June 22, 12:30 to 1:30 p.m. CDTLocation: Poster Hall (Hall F1)Presenter: Ansarullah, PhD Eloralintide (investigational amylin receptor agonist):Presentation Title: Eloralintide (LY3841136), a Selective Amylin Mimetic, Lowered Body Weight with Improved Quality of Weight Loss and GI Tolerability in Rats Compared with CagrilintideAbstract Number: 849-PPresentation Date & Time: Sunday, June 22, 12:30 to 1:30 p.m. CDTLocation: Poster Hall (Hall F1)Presenter: Daniel A Briere Presentation Title: Eloralintide, a Selective, Long-Acting Amylin Receptor Agonist for Obesity—Phase 1 Proof of ConceptAbstract Number: 882-PPresentation Date & Time: Sunday, June 22, 12:30 to 1:30 p.m. CDTLocation: Poster Hall (Hall F1)Presenter: Edward J. Pratt, MD Bimagrumab (investigational activin pathway inhibitor):Presentation Title: Can We Improve the Quality of Weight Loss by Augmenting Fat Mass Loss while Preserving Lean Mass? The BELIEVE Study of Bimagrumab + SemaglutidePresentation Date & Time: Monday, June 23, 8 to 9:30 a.m. CDTLocation: W375 APresenters: Lee M. Kaplan, MD, PhD; Ronenn Roubenoff, MD, MHS; Penelope Montgomery, MD; Steven B. Heymsfield, MD; Louis J. Aronne, MD, FACP, DABOM; Ania M. Jastreboff, MD, PhD About orforglipron Orforglipron (or-for-GLIP-ron) is an investigational, once-daily small molecule (non-peptide) oral glucagon-like peptide-1 (GLP-1) receptor agonist that can be taken any time of the day without restrictions on food and water intake. Orforglipron was discovered by Chugai Pharmaceutical Co., Ltd. and licensed by Lilly in 2018. Chugai and Lilly published preclinical pharmacology data for this molecule together. Lilly is running Phase 3 studies on orforglipron for the treatment of type 2 diabetes and for weight management in adults with obesity or overweight with at least one weight-related medical problem. It is also being studied as a potential treatment for obstructive sleep apnea and hypertension in adults with obesity. About insulin efsitora alfa Insulin efsitora alfa (efsitora) is an investigational once-weekly basal insulin, a fusion protein that combines a novel single-chain variant of insulin with a human IgG2 Fc domain. It is specifically designed for once-weekly subcutaneous administration, and with its low peak-to-trough ratio, it has the potential to provide more stable glucose levels (less glucose variability) throughout the week. Efsitora is in Phase 3 development for adults with type 1 and 2 diabetes. About retatrutideRetatrutide is an investigational once-weekly triple hormone receptor agonist. Retatrutide is a single molecule that activates the body's receptors for glucose-dependent insulinotropic polypeptide (GIP), GLP-1, and glucagon. Lilly is studying retatrutide in several Phase 3 clinical trials to evaluate its potential efficacy and safety in obesity and type 2 diabetes, as well as across multiple obesity-related complications, such as osteoarthritis and obstructive sleep apnea. About eloralintideEloralintide is an investigational selective, long-acting amylin receptor agonist designed to mimic the effects of native amylin while potentially improving tolerability and quality of weight loss. Lilly is studying eloralintide in clinical trials to evaluate its potential efficacy and safety in obesity. About bimagrumabBimagrumab is an investigational monoclonal antibody that blocks activin type II receptors, which may promote muscle growth and fat mass reduction. Bimagrumab was discovered by Novartis and later advanced by Versanis Bio for the treatment of obesity. Versanis Bio was acquired by Lilly in 2023. Lilly is currently running studies of bimagrumab in combination with incretins to assess its ability to improve the quality of weight loss by preserving lean mass while reducing fat mass in adults with overweight or obesity. About tirzepatide Tirzepatide is a once-weekly dual GIP receptor and GLP-1 receptor agonist. Tirzepatide is a single molecule that activates the body's receptors for GIP and GLP-1, which are natural incretin hormones. Both GIP and GLP-1 receptors are found in areas of the human brain important for appetite regulation. Tirzepatide decreases calorie intake, and the effects are likely mediated by affecting appetite. Studies of tirzepatide in chronic kidney disease (CKD) and morbidity/mortality in obesity (MMO) are ongoing. Tirzepatide has been approved by the U.S. FDA as Mounjaro for adults with type 2 diabetes to improve glycemic control, and as Zepbound for adults with obesity, or some adults who are overweight and also have at least one weight-related medical problem, to lose weight and keep it off. Additionally, Zepbound is FDA-approved to treat adults with moderate-to-severe obstructive sleep apnea and obesity. Tirzepatide is also approved as Mounjaro in some countries outside the U.S. for adults with type 2 diabetes, obesity or those who are overweight who also have a weight-related comorbid condition. Both Mounjaro and Zepbound should be used in combination with diet and exercise. INDICATIONS AND SAFETY SUMMARY WITH WARNINGS Zepbound (ZEHP-bownd) is an injectable prescription medicine that may help adults with: obesity, or some adults with overweight who also have weight-related medical problems to lose excess body weight and keep the weight off. moderate-to-severe obstructive sleep apnea (OSA) and obesity to improve their OSA. It should be used with a reduced-calorie diet and increased physical activity. Zepbound contains tirzepatide and should not be used with other tirzepatide-containing products or any GLP-1 receptor agonist medicines. It is not known if Zepbound is safe and effective for use in children. Warnings - Zepbound may cause tumors in the thyroid, including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, hoarseness, trouble swallowing, or shortness of breath. If you have any of these symptoms, tell your healthcare provider. Do not use Zepbound if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC). Do not use Zepbound if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Do not use Zepbound if you have had a serious allergic reaction to tirzepatide or any of the ingredients in Zepbound. Zepbound may cause serious side effects, including: Severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Zepbound. Tell your healthcare provider if you have stomach problems that are severe or will not go away. Kidney problems (kidney failure). Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration. Gallbladder problems. Gallbladder problems have happened in some people who use Zepbound. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include pain in your upper stomach (abdomen), fever, yellowing of skin or eyes (jaundice), or clay-colored stools. Inflammation of the pancreas (pancreatitis). Stop using Zepbound and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back. Serious allergic reactions. Stop using Zepbound and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, or very rapid heartbeat. Low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Zepbound with medicines that can cause low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms of low blood sugar may include dizziness or light-headedness, sweating, confusion or drowsiness, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, mood changes, hunger, weakness or feeling jittery. Changes in vision in patients with type 2 diabetes. Tell your healthcare provider if you have changes in vision during treatment with Zepbound. Depression or thoughts of suicide. You should pay attention to changes in your mood, behaviors, feelings or thoughts. Call your healthcare provider right away if you have any mental changes that are new, worse, or worry you. Food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). Zepbound may increase the chance of food getting into your lungs during surgery or other procedures. Tell all your healthcare providers that you are taking Zepbound before you are scheduled to have surgery or other procedures. Common side effects The most common side effects of Zepbound include nausea, diarrhea, vomiting, constipation, stomach (abdominal) pain, indigestion, injection site reactions, feeling tired, allergic reactions, belching, hair loss, and heartburn. These are not all the possible side effects of Zepbound. Talk to your healthcare provider about any side effect that bothers you or doesn't go away. Tell your doctor if you have any side effects. You can report side effects at 1-800-FDA-1088 or Before using Zepbound Your healthcare provider should show you how to use Zepbound before you use it for the first time. Tell your healthcare provider if you are taking medicines to treat diabetes including an insulin or sulfonylurea which could increase your risk of low blood sugar. Talk to your healthcare provider about low blood sugar levels and how to manage them. If you take birth control pills by mouth, talk to your healthcare provider before you use Zepbound. Birth control pills may not work as well while using Zepbound. Your healthcare provider may recommend another type of birth control for 4 weeks after you start Zepbound and for 4 weeks after each increase in your dose of Zepbound. Review these questions with your healthcare provider: ❑ Do you have other medical conditions, including problems with your pancreas or kidneys, or severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems digesting food? ❑ Do you take diabetes medicines, such as insulin or sulfonylureas? ❑ Do you have a history of diabetic retinopathy? ❑ Are you scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation)? ❑ Do you take any other prescription medicines or over-the-counter drugs, vitamins, or herbal supplements? ❑ Are you pregnant, plan to become pregnant, breastfeeding, or plan to breastfeed? Zepbound may harm your unborn baby. Tell your healthcare provider if you become pregnant while using Zepbound. It is not known if Zepbound passes into your breast milk. You should talk with your healthcare provider about the best way to feed your baby while using Zepbound. Pregnancy Exposure Registry: There will be a pregnancy exposure registry for women who have taken Zepbound during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry, or you may contact Lilly at 1-800-LillyRx (1-800-545-5979). How to take Read the Instructions for Use that come with Zepbound. Use Zepbound exactly as your healthcare provider says. Use Zepbound with a reduced-calorie diet and increased physical activity. Zepbound is injected under the skin (subcutaneously) of your stomach (abdomen), thigh, or upper arm. Use Zepbound 1 time each week, at any time of the day. Change (rotate) your injection site with each weekly injection. Do not use the same site for each injection. If you take too much Zepbound, call your healthcare provider, seek medical advice promptly, or contact a Poison Center expert right away at 1-800-222-1222. Zepbound injection is approved as a 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg per 0.5 mL in single-dose pen or single-dose vial. Learn more Zepbound is a prescription medicine. For more information, call 1-800-LillyRx (1-800-545-5979) or go to This summary provides basic information about Zepbound but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your healthcare provider. Be sure to talk to your healthcare provider about Zepbound and how to take it. Your healthcare provider is the best person to help you decide if Zepbound is right for you. ZP CON BS 20DEC2024 Zepbound® and its delivery device base are registered trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates. INDICATION AND SAFETY SUMMARY WITH WARNINGS Mounjaro® (mown-JAHR-OH) is an injectable medicine for adults with type 2 diabetes used along with diet and exercise to improve blood sugar (glucose). It is not known if Mounjaro can be used in people who have had inflammation of the pancreas (pancreatitis). Mounjaro is not for use in people with type 1 diabetes. It is not known if Mounjaro is safe and effective for use in children under 18 years of age. Warnings - Mounjaro may cause tumors in the thyroid, including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, hoarseness, trouble swallowing, or shortness of breath. If you have any of these symptoms, tell your healthcare provider. Do not use Mounjaro if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC). Do not use Mounjaro if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Do not use Mounjaro if you are allergic to it or any of the ingredients in Mounjaro. Mounjaro may cause serious side effects, including: Inflammation of the pancreas (pancreatitis). Stop using Mounjaro and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back. Low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Mounjaro with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms of low blood sugar may include dizziness or light-headedness, sweating, confusion or drowsiness, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, or mood changes, hunger, weakness and feeling jittery. Serious allergic reactions. Stop using Mounjaro and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, and very rapid heartbeat. Kidney problems (kidney failure). In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems to get worse. It is important for you to drink fluids to help reduce your chance of dehydration. Severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Mounjaro. Tell your healthcare provider if you have stomach problems that are severe or will not go away. Changes in vision. Tell your healthcare provider if you have changes in vision during treatment with Mounjaro. Gallbladder problems. Gallbladder problems have happened in some people who use Mounjaro. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include pain in your upper stomach (abdomen), fever, yellowing of skin or eyes (jaundice), and clay-colored stools. Food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). Mounjaro may increase the chance of food getting into your lungs during surgery or other procedures. Tell all your healthcare providers that you are taking Mounjaro before you are scheduled to have surgery or other procedures. Common side effects The most common side effects of Mounjaro include nausea, diarrhea, decreased appetite, vomiting, constipation, indigestion, and stomach (abdominal) pain. These are not all the possible side effects of Mounjaro. Talk to your healthcare provider about any side effect that bothers you or doesn't go away. Tell your healthcare provider if you have any side effects. You can report side effects at 1-800-FDA-1088 or Before using Mounjaro Your healthcare provider should show you how to use Mounjaro before you use it for the first time. Talk to your healthcare provider about low blood sugar and how to manage it. If you take birth control pills by mouth, talk to your healthcare provider before you use Mounjaro. Birth control pills may not work as well while using Mounjaro. Your healthcare provider may recommend another type of birth control for 4 weeks after you start Mounjaro and for 4 weeks after each increase in your dose of Mounjaro. Review these questions with your healthcare provider:❑ Do you have other medical conditions, including problems with your pancreas or kidneys, or severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems digesting food?❑ Do you take other diabetes medicines, such as insulin or sulfonylureas?❑ Do you have a history of diabetic retinopathy?❑ Are you scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation)?❑ Are you pregnant, plan to become pregnant, breastfeeding, or plan to breastfeed? It is not known if Mounjaro will harm your unborn baby or pass into your breast milk.❑ Do you take any other prescription medicines or over-the-counter drugs, vitamins, or herbal supplements? How to take Read the Instructions for Use that come with Mounjaro. Use Mounjaro exactly as your healthcare provider says. Mounjaro is injected under the skin (subcutaneously) of your stomach (abdomen), thigh, or upper arm. Use Mounjaro 1 time each week, at any time of the day. Do not mix insulin and Mounjaro together in the same injection. You may give an injection of Mounjaro and insulin in the same body area (such as your stomach area), but not right next to each other. Change (rotate) your injection site with each weekly injection. Do not use the same site for each injection. If you take too much Mounjaro, call your healthcare provider or seek medical advice promptly. Learn more Mounjaro is a prescription medicine available as a pre-filled single-dose pen in 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg per 0.5 mL injection. For more information, call 1-833-807-MJRO (833-807-6576) or go to This summary provides basic information about Mounjaro but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your healthcare provider. Be sure to talk to your healthcare provider about Mounjaro and how to take it. Your healthcare provider is the best person to help you decide if Mounjaro is right for you. TR CON CBS 05NOV2024Mounjaro® and its delivery device base are registered trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates. About LillyLilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit and or follow us on Facebook, Instagram and LinkedIn. P-LLY Trademarks and Trade NamesAll trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are references in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company's or their rights thereto. We do not intend the use or display of other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies. Cautionary Statement Regarding Forward-Looking StatementsThis press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995), including statements regarding the efficacy, safety and potential regulatory progress of Lilly's investigational medicines such as orforglipron as a potential treatment for adults with type 2 diabetes, insulin efsitora alfa as a potential treatment for adults with type 2 diabetes, retatrutide for potential use across multiple cardiometabolic indications, bimagrumab for potential use alone and in combination with other GLP-1 therapies in adults with overweight or obesity, eloralintide as a potential treatment for obesity and weight management, statements about the efficacy and safety of Zepbound (tirzepatide) as an approved treatment for adults with obesity or overweight, statements about the efficacy and safety of Mounjaro (tirzepatide) as an approved treatment for adults with type 2 diabetes, and reflects Lilly's current belief and expectations. However, as with any investigational and pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there can be no guarantee that studies will be initiated or completed as planned, that future study results will be consistent with the results to date, that investigational medicines will receive regulatory approval, or that approved medicines will achieve anticipated commercial success. Additionally, regulatory timelines and commercialization efforts may evolve based on emerging data, competitive dynamics, and regulatory interactions. For further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release. Refer to: Brooke Frost; 317-432-9145 (Media)Michael Czapar; czapar_michael_c@ 317-617-0983 (Investors) View original content to download multimedia: SOURCE Eli Lilly and Company Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
