Latest news with #ACHIEVE-1
Yahoo
14-05-2025
- Health
- Yahoo
New Diet Pill Shows Similar Effects to Ozempic
Whether it's drawing blood or administering medication, needles scare many people, and not everyone can imagine doing it themselves. However, when it comes to severe obesity and Type 2 diabetes, GLP-1 receptor agonists—such as Ozempic and Wegovy—are effective aids. The catch: the medication must be regularly injected with a needle. But a new 'weight loss pill' could soon replace this method. Is the pill for obesity coming? Pharmaceutical company Eli Lilly has released initial Phase 3 results for Orforglipron—the world's first oral GLP-1 pill that significantly lowers blood sugar and reduces weight. Phase 3 studies are the final stage before potential approval, testing a drug's efficacy and safety. Orforglipron's effects are comparable to existing GLP-1 treatments that require injections. According to the World Health Organization (WHO), one in eight people worldwide suffered from obesity in 2022. This form of overweight is defined by a body mass index of 30 or higher. Among adults, obesity cases have more than doubled globally since 1990, and among adolescents, they have quadrupled.1 Consequently, the risk of diseases such as type 2 diabetes, cardiovascular diseases, cancer, and others increases. As future projections—cautiously stated—do not look promising, immediate measures to address this health crisis are necessary, according to the medical journal The Lancet.2 Chugai Pharmaceutical developed Orforglipron in 2018, later licensed by Eli Lilly. The active ingredient belongs to the group of GLP-1 receptor agonists—medications that mimic the body's hormone GLP-1 to regulate blood sugar levels, reduce hunger, and delay gastric emptying. Unlike known injectable substances like semaglutide, found in Ozempic, Orforglipron is based on a small molecule rather than a peptide. This is the crucial difference: It is not immediately broken down in the digestive tract and can therefore be taken as a pill. One pill per day is required, with no dietary restrictions. The simple form of administration could present a lower barrier for many affected individuals compared to regular injections. The pharmaceutical company tested Orforglipron in the Phase 3 study ACHIEVE-1. This clinical trial involved 559 overweight adults with type 2 diabetes whose blood sugar levels were not within the desired range despite diet and exercise. The HbA1c value, which provides information about blood sugar over the past two to three months, served as a marker. In healthy individuals, this value is about 5.7 percent. For type 2 diabetics, values between 6.5 and 7.5 percent are targeted in therapy.3 However, at the start of the study, participants had an average HbA1c value of 8.0 percent and weighed around 90 kilograms. They were randomly assigned to one of four groups: three different dosages of Orforglipron (3, 12, and 36 milligrams) or a placebo. The treatment lasted 40 weeks. All participants started with a low initial dose and gradually increased to the target amount. The goal was to evaluate the blood sugar-lowering effect of the medication compared to placebo. No other diabetes medications were taken during this time. Indeed, Orforglipron showed a significant reduction in HbA1c values across all dosages. The average decrease ranged from 1.3 to 1.6 percentage points, an effect comparable to injectable GLP-1 agents like semaglutide. Over 65 percent of participants receiving the highest dose achieved an HbA1c value of 6.5 percent or lower—below the diabetes threshold. The question now on everyone's mind: Does the pill work as well against obesity as the injections? The study showed that participants lost an average of 7.3 kilograms, about eight percent of their initial weight. However, tirzepatide demonstrated a higher weight loss of 16 to 21 percent in approval studies.4 Ozempic also achieved a notable 15 percent after just over a year of use.5 Eli Lilly's press release notes that the weight loss of their participants is not yet complete, meaning the plateau has not been reached. The potential effect could exceed eight percent—but that remains to be seen.6 Despite oral administration, Orforglipron's side effects are similar to those of known GLP-1 therapies. Gastrointestinal issues were most common, including nausea, vomiting, diarrhea, and constipation. These side effects were mostly mild to moderate and led to therapy discontinuation in only a few cases. Discontinuation rates due to adverse events ranged from four to eight percent—compared to one percent in the placebo group. Cardiologist Professor Naveed Sattar from the University of Glasgow sees great potential in the study results. 'These are important findings. New oral agents that lower blood sugar and significantly reduce weight beyond the levels of most existing diabetes therapies are crucial for the future treatment of type 2 diabetes. Current research has shown that obesity not only leads to type 2 diabetes in many people but also significantly contributes to many associated complications. Targeted weight loss often also improves patients' quality of life,' he commented.7 However, Sattar also emphasizes that not all questions have been answered: 'One caveat is that we do not yet know the effects of this newer therapy on cardiovascular events, but future studies will show this. It is also encouraging to learn about the safety profile of these new oral GLP-1RA medications—especially regarding liver values—and we look forward to seeing the data in a full publication in due course.' The results of the ACHIEVE-1 study will be presented at this year's American Diabetes Association annual meeting in June and are set to be published in a scientific journal. Lilly also plans to release more data from the clinical Phase 3 study series 'ACHIEVE' soon. Additionally, new results from the parallel study 'ATTAIN,' which specifically investigates Orforglipron for weight control, will be available soon. Eli Lilly plans to apply for approval for the treatment of obesity with the U.S. Food and Drug Administration (FDA) later this year, followed by an application for diabetes treatment in early 2026. The company emphasizes that no supply shortages are expected upon approval. Weltgesundheitsorganisation (WHO). Obesity and overweight. (accessed May 13, 2025) ↩︎ Kerr, J. A. et al. (2021). Global, regional, and national prevalence of child and adolescent overweight and obesity, 1990–2021, with forecasts to 2050: a forecasting study for the Global Burden of Disease Study. The Lancet. ↩︎ Helios. Blutzuckerwerte und ihre Bedeutung. (accessed May 14, 2025) ↩︎ Wilding, J.P.H., et al. (2022). Once-Weekly Semaglutide in Adults with Overweight or Obesity. New England Journal of Medicine., et al. (2022). Once-Weekly Semaglutide in Adults With Overweight or Obesity. New England Journal of Medicine. ↩︎ Wilding, J. P. H. et al. (2021). Once-Weekly Semaglutide in Adults with Overweight or Obesity. New England Journal of Medicine. ↩︎ Eli Lilly. Lilly's oral GLP-1, orforglipron, demonstrated statistically significant efficacy results and a safety profile consistent with injectable GLP-1 medicines in successful Phase 3 trial. (accessed May 14, 2025) ↩︎ UK Science Media Centre. expert reaction to top line results in Lilly press release about their phase 3 ACHIEVE-1 trial of their oral GLP-1 (orforglipron) and weight loss efficacy, and safety. (accessed May 14, 2025). ↩︎ The post New Diet Pill Shows Similar Effects to Ozempic appeared first on FITBOOK.
Yahoo
21-04-2025
- Business
- Yahoo
LLY Stock Up as Oral GLP-1 Pill Meets Goals in First Phase III Study
Shares of Eli Lilly LLY soared 14.3% on April 17 after data from a late-stage study showed that orforglipron achieved the primary goal of significantly reducing A1C levels compared to placebo at 40 weeks, with an average A1C reduction of 1.3% to 1.6% from a baseline of 8%. LLY's orforglipron is an investigational, once-daily small-molecule oral GLP-1 receptor agonist that can be administered at any time of the day without restrictions on food and water intake. The phase III ACHIEVE-1 study, the first of seven late-stage studies, is evaluating the safety and efficacy of orforglipron compared to placebo in adults with type 2 diabetes (T2D) and inadequate glycemic control with diet and exercise alone. The enrolled patients in the 40-week study were randomized equally to receive either a 3 mg, 12 mg or 36 mg dose of orforglipron or placebo. Lilly is also developing a version of this oral drug for obesity. The candidate also met the key secondary endpoint in the ACHIEVE-1 study, as more than 65% of the patients receiving the highest dose of orforglipron reached A1C levels of 6.5% or lower — the threshold used by the American Diabetes Association to define diabetes. Additionally, patients taking the highest 36 mg dose lost an average of 16 pounds, which translates to 7.9% of their total body weight, another key secondary endpoint. Interestingly, weight loss was still ongoing when the study concluded. This suggests that a higher weight loss percentage may be observed with the candidate over a longer treatment duration. Year to date, shares of Lilly have gained 8.8% against the industry's 3.3% decline. Image Source: Zacks Investment Research Additionally, analysis of the phase III study data, regardless of treatment adherence, showed that patients receiving orforglipron achieved statistically significant reductions in A1C across all doses, with the 12 mg and 36 mg doses also showing statistically significant weight loss. The overall safety profile of orforglipron in the ACHIEVE-1 study aligned with that of other GLP-1 therapies. Side effects were typically mild to moderate in intensity. The highest rate of treatment discontinuation due to adverse events (8%) was observed in the patient cohort receiving the 36 mg dose of orforglipron. Lilly in-licensed the candidate from Chugai Pharmaceutical in 2018. Apart from the T2D and obesity indications, orforglipron is also being explored as a potential treatment for obstructive sleep apnea and hypertension in adults with obesity. Lilly expects to report additional results from the phase III ACHIEVE clinical program, as well as data readout from the phase III ATTAIN clinical program evaluating orforglipron for weight management, later this year. It plans to submit applications to global regulatory authorities seeking the approval of orforglipron for weight management by the end of this year. Submission of regulatory applications seeking the approval of the candidate for T2D is expected in 2026. Eli Lilly and Novo Nordisk NVO currently dominate the diabetes and obesity-care market on the back of the tremendous success of their GLP-1 injections. Lilly markets its dual GIP and GLP-1 receptor agonist, tirzepatide, as Mounjaro for T2D and Zepbound for obesity, while Novo Nordisk markets its semaglutide drugs as Ozempic for T2D and Wegovy for weight management. NVO also markets Rybelsus as an oral medication for adults with T2D to control blood sugar levels, but unlike orforglipron, Rybelsus therapy has restrictions on food and water intake. Lilly's recent phase III ACHIEVE-1 success reinforces its frontrunner status in the race to develop an oral diabetes/obesity therapy. In response to LLY's successful study data, NVO's stock lost 7.6% in the last trading session. Oral medications, being more convenient than injectables, tend to boost patient adherence. Novo Nordisk is developing its oral obesity pill, amycretin, in a mid-stage study. Amycretin is a dual receptor agonist that targets two key gut hormones, GLP-1 and amylin. Eli Lilly and Company price-consensus-chart | Eli Lilly and Company Quote Lilly's first phase III success for orforglipron has also confirmed the potential efficacy of oral pills for weight management, which, if approved, would be preferred over injectable options. This likely resulted in the stock price gains of Structure Therapeutics GPCR and Viking Therapeutics VKTX, which are currently developing oral GLP-1-based obesity candidates in their pipeline in mid-stage studies. Shares of Structure Therapeuticssoared 17.4% following LLY's news. GPCR is conducting multiple mid-stage studies on its lead candidate, aleniglipron (GSBR-1290), a highly selective oral GLP-1 receptor agonist, for treating healthy overweight or obese individuals. On the other hand, shares of Viking Therapeutics gained 1.4%.VKTX is currently evaluating the safety and efficacy of the oral formulation of its experimental obesity drug, VK2735, in a mid-stage study. Last month, Viking Therapeutics reported that it has completed enrollment in the phase II VENTURE-Oral Dosing study of the candidate for the obesity indication. Data from this study is expected in the second half of 2025. The rapid advancements being made by Viking Therapeutics and Structure Therapeutics in the development of their respective oral obesity treatment candidates have made them lucrative targets for collaboration or M&A deals. Eli Lilly currently carries a Zacks Rank #3 (Hold). You can see the complete list of today's Zacks #1 (Strong Buy) Rank stocks here. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Novo Nordisk A/S (NVO) : Free Stock Analysis Report Eli Lilly and Company (LLY) : Free Stock Analysis Report Viking Therapeutics, Inc. (VKTX) : Free Stock Analysis Report Structure Therapeutics Inc. Sponsored ADR (GPCR) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research
Yahoo
19-04-2025
- Business
- Yahoo
Eli Lilly jumps as results from weight-loss pill study rival competitor's
Shares of Eli Lilly (LLY) jumped on Thursday morning after the company announced topline Phase 3 results from ACHIEVE-1, 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. Commenting on the news, Leerink said that the once-daily oral GLP-1 pill showed similar efficacy and safety relative to weekly injectable semaglutide, made by Novo Nordisk (NVO). Discover outperforming stocks and invest smarter with Top Smart Score Stocks. Filter, analyze, and streamline your search for investment opportunities using Tipranks' Stock Screener. PRIMARY ENDPOINT MET: Eli Lilly announced topline Phase 3 results from ACHIEVE-1, 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 glucagon-like peptide-1 receptor agonist, taken without food and water restrictions, to successfully complete a Phase 3 trial. If approved, the company is confident in its ability to launch orforglipron worldwide without supply constraints. This would further Lilly's mission to reduce chronic diseases like type 2 diabetes, which is expected to impact an estimated 760 million adults by 2050. In the first Phase 3 trial of the ACHIEVE program, orforglipron met the primary endpoint of superior A1C reduction compared to placebo at 40 weeks, lowering A1C by an average of 1.3% to 1.6% from a baseline of 8%, using the efficacy estimand. In a key secondary endpoint, more than 65% of participants taking the highest dose of orforglipron achieved an A1C less than or equal to 6.5%, which is below the American Diabetes Association's defined threshold for diabetes. In an additional key secondary endpoint, participants taking orforglipron lost an average of 16.0 lbs at the highest dose. Given that participants had not yet reached a weight plateau at the time the study ended, it appears that full weight reduction was not yet attained. The overall safety profile of orforglipron in ACHIEVE-1 was consistent with the established GLP-1 class. Overall treatment discontinuation rates due to adverse events were 6%, 4% and 8% for orforglipron vs. 1% with placebo. No hepatic safety signal was observed. Lilly expects to submit orforglipron for weight management to global regulatory agencies by the end of this year, with the submission for the treatment of type 2 diabetes anticipated in 2026. PICTURE-PERFECT: Calling the results 'picture-perfect,' Leerink notes Eli once-daily oral GLP-1 pill showed similar efficacy and safety relative to weekly injectable semaglutide, made by Novo Nordisk. Importantly, the press release stated that 'no hepatic safety signal was observed.' The firm expects the next orforglipron Phase 3 topline result in Q3 2025, and it expects orforglipron to be approved in 2026. Leerink reiterates an Outperform rating on Eli Lilly's shares. HIGHLY COMPETITIVE: JPMorgan says Eli Lilly released Phase 3 data for orforglipron in type 2 diabetes today, and overall the results suggest a 'highly competitive profile' for the drug. Orforglipron was highly efficacious on HbA1c, but weight loss was the primary focus for investors and here orforglipron showed a 6.3% placebo adjusted reduction from baseline at its highest dose, which is largely comparable to Wegovy and in line with Street expectations for 5%-6% weight loss, the firm tells investors in a research note. JPMorgan adds that tolerability looks manageable with only an 8% discontinuation rate on the high dose. JPMorgan has an Overweight rating on Eli Lilly shares. HIGHLY FAVORABLE FOR STRUCTURE: In a separate note, JPMorgan says Eli Lilly's Phase 3 data for orforglipron in type 2 diabetes suggest a 'highly competitive profile' for the drug. The firm views the data as its base case scenario, whereby Structure Therapeutics (GPCR) shares could be up double-digit percent in this scenario on a 'highly favorable read-through' and Viking Therapeutics (VKTX) could move mid-single-digit in either direction. JPMorgan's focus was primarily on orfoglipron's tolerability profile with the extended titration, and here the data is highlighted by an 8% discontinuation rate on the highest dose versus low-teens expectations. The firm sees the data as 'helping derisk the category,' giving more confidence that Structure can also bring tolerability of aleniglipron to reasonable levels. For Viking, the read-through is not as direct, and today's data 'clearly helps derisk a strong' first in class oral competitor from Lilly, which could limit the potential of late entrant injectable assets, says JPMorgan. However, the firm believes the data 'still leaves a clear role' for Viking's 'highly tolerable' oral VK-2735. PRICE ACTION: In morning trading, shares of Eli Lilly have climbed over 13% to $832.05, while Structure Therapeutics moved 10% higher to $20.37. Trading lower following the news, Viking Therapeutics has dropped more than 3% to $22.81. Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>> See the top stocks recommended by analysts >> Read More on LLY: Disclaimer & DisclosureReport an Issue JPMorgan says Lilly data 'highly favorable' for Structure Therapeutics Eli Lilly rises 16.3% Early notable gainers among liquid option names on April 17th Eli Lilly rises 13.0% Unusually active option classes on open April 17th
Yahoo
19-04-2025
- Business
- Yahoo
Novo Nordisk downgraded by BMO as Eli Lilly gains ground in weight-loss drug race
-- BMO Capital Markets downgraded Novo Nordisk (NYSE:NVO) to 'Market Perform' from 'Outperform' and cut its price target to $64, saying the Danish drugmaker's early lead in the obesity drug market is being overtaken by rival Eli Lilly's rapidly advancing pipeline. The brokerage said Lilly's progress with its oral GLP-1 candidate, orforglipron, and increasing prescription strength for its injectable drug tirzepatide suggest it is now pulling ahead in the booming market for incretin-based weight-loss treatments. While Novo had the head start with semaglutide, BMO analysts believe the first-mover advantage has waned. BMO says that Lilly's growing edge in both clinical and commercial fronts is set to intensify with upcoming data from its ACHIEVE-1 trial in Type 2 diabetes. Novo's lack of a clear small-molecule strategy beyond peptides in the oral segment is likely to hamper its long-term growth, BMO added. The firm also flagged continued fallout from last year's supply disruptions of semaglutide, which may have pushed physicians to favor Lilly's tirzepatide more permanently. Novo's next catalysts, including Alzheimer's-related trials EVOKE and EVOKE+, could provide upside, but BMO described them as high risk and unlikely to shift sentiment meaningfully in the near term The stock is down roughly 34% so far this year despite the soaring demand for its GLP-1-based therapies, Wegovy and Ozempic. Related articles Novo Nordisk downgraded by BMO as Eli Lilly gains ground in weight-loss drug race U.S. shoppers spend $1.5 trillion a year. Here's which retailers win – Bernstein Elliott said to pressure HPE Board to replace CEO Antonio Neri Sign in to access your portfolio
Yahoo
18-04-2025
- Business
- Yahoo
Novo Nordisk shares slump following Eli Lilly's weight-loss pill success
-- Novo Nordisk A/S (NYSE:NVO) shares fell as much as 8% in Thursday trading after news emerged about a competitor's successful drug trial. Eli Lilly and Company (NYSE:LLY) announced today that its ACHIEVE-1 trial for the oral GLP-1 medication, orforglipron, met its primary endpoint in type 2 diabetes patients. The trial results showed significant A1C reduction and weight loss, which are seen as competitive to Novo's offerings. The ACHIEVE-1 trial results revealed an average A1C reduction of 1.3-1.6% across different doses, with the highest dose leading to a 7.9% weight loss at 40 weeks. The weight loss reported is at the upper end of investor expectations and notably has not plateaued, indicating potential for further benefits. Despite higher rates of gastrointestinal side effects compared to injectable treatments like semaglutide and tirzepatide, discontinuation rates remained below the clinical threshold of 10%. "These orforglipron T2D Ph3 efficacy results compare favorably cross-trial to NVO's injectable semaglutide; the caveat is that neither semaglutide trial is a perfect comp," Leerink Partners analysts wrote in a note. Barclays analysts think that this increases the pressure on management to bring a small molecule GLP-1 into its portfolio. "Of course, this has been an overhang on Novo shares for quite some time, so the data reported today doesn't dramatically change things, in our view. What we consider far more important is whether we will see script growth for Wegovy after compounding rolls off in the US as CagriSema won't be launched until likely 2027 and we think scripts need to grow in that interim period to support an above-peer multiple." The full trial data from Eli Lilly will be presented at the American Diabetes Association (ADA) meeting on June 21, which may provide further insights into the competitive landscape for diabetes and obesity treatments. Related articles Novo Nordisk shares slump following Eli Lilly's weight-loss pill success JP Morgan downgrades Sea, sees Grab as more resilient amid macro headwinds Seaport downgrades PayPal and ahead of Q1 earnings on macro concerns Sign in to access your portfolio
