Latest news with #LillyCardiometabolicHealth
Mid East Info
15 hours ago
- Health
- Mid East Info
Lilly's Mounjaro (tirzepatide), a GIP/GLP-1 dual agonist, demonstrated cardiovascular protection in landmark head-to-head trial, reinforcing its benefit in patients with type 2 diabetes and heart disease
Mounjaro met the primary objective of non-inferiority vs. Trulicity with an 8% lower rate of MACE-3 events, while delivering greater reductions in A1C and weight In the trial, Mounjaro was associated with a 16% lower rate of all-cause death compared to Trulicity, suggesting more comprehensive health benefits Results from the largest and longest Mounjaro trial to date reaffirm its established safety and tolerability profile Abu Dhabi, United Arab Emirates. August, 2025: Eli Lilly and Company (NYSE: LLY) today announced topline results from SURPASS-CVOT, a first-of-its-kind head-to-head Phase 3 cardiovascular outcomes trial comparing two incretin therapies in adults with type 2 diabetes and established atherosclerotic cardiovascular disease. Mounjaro (tirzepatide), a GIP/GLP-1 dual receptor agonist, was compared to Trulicity (dulaglutide), a GLP-1 receptor agonist that showed a definitive cardiovascular benefit in the REWIND study. In SURPASS-CVOT, Mounjaro achieved the primary objective by demonstrating a non-inferior rate of major adverse cardiovascular events (MACE-3), including cardiovascular death, heart attack or stroke vs. Trulicity. In addition, while not controlled for multiplicity-adjusted type-1 error, Mounjaro showed improvements on key measures of A1C, weight, renal function and all-cause mortality. The trial, which enrolled more than 13,000 participants across 30 countries and lasted more than four and a half years, is the largest and longest study of tirzepatide to date. 'Cardiovascular disease remains the leading cause of death among people living with type 2 diabetes,' said Kenneth Custer, Ph.D., executive vice president and president, Lilly Cardiometabolic Health. 'The SURPASS-CVOT results show that Mounjaro preserved the cardioprotective benefit of Trulicity, a GLP-1 receptor agonist, while providing additional benefits, including greater kidney protection and a reduced overall risk of death. These findings strengthen the case for Mounjaro as a potential front-line treatment for people with type 2 diabetes and cardiovascular disease.' In the trial, the risk of cardiovascular death, heart attack, or stroke was 8% lower for Mounjaro vs. Trulicity (hazard ratio: 0.92; 95.3% CI: 0.83 to 1.01), meeting the prespecified criteria for non-inferiority (upper limit of 95.3% CI of the hazard ratio < 1.05).1,2 Mounjaro showed consistent results across all three components of the MACE-3 composite endpoint. The rate of all-cause mortality was 16% lower for Mounjaro vs. Trulicity (hazard ratio: 0.84; 95.0% CI: 0.75 to 0.94).1,3 A pre-specified indirect comparison analysis of matched patient-level data from the REWIND and SURPASS-CVOT studies found that Mounjaro reduced the risk of MACE-3 by 28% (hazard ratio: 0.72; 95.0% CI: 0.55 to 0.94) and all-cause mortality by 39% (hazard ratio: 0.61; 95.0% CI: 0.45 to 0.82) compared to a putative placebo.3,4 In another key pre-specified analysis of participants with high or very-high risk of chronic kidney disease, Mounjaro slowed eGFR decline by 3.54 mL/min/1.73 m2 at 36 months vs. Trulicity (95.0% CI: 2.57 to 4.50).3,5,6 In the trial, Mounjaro also led to greater improvements in A1C, weight and cardiovascular biomarkers, including lipids and systolic blood pressure, compared to Trulicity.3 The safety and tolerability of Mounjaro and Trulicity were generally consistent with their established profiles. The most commonly reported adverse events in SURPASS-CVOT for both Mounjaro and Trulicity were gastrointestinal-related, generally mild-to-moderate in severity, and mostly resolved after dose escalation was complete. During the trial, 13.3% of participants taking Mounjaro discontinued treatment due to adverse events, compared to 10.2% of participants taking Trulicity.7 Detailed results for SURPASS-CVOT will be presented at the European Association for the Study of Diabetes (EASD) Annual Meeting 2025 in September and published in a peer-reviewed journal. Lilly plans to submit these data to global regulatory authorities by the end of this year. About SURPASS-CVOT: SURPASS-CVOT Cardiovascular Outcomes Trial; NCT04255433 was an event-driven, randomized, double-blind, parallel group Phase 3 trial evaluating the efficacy and safety of Mounjaro (tirzepatide) compared with Trulicity (dulaglutide) in adults with type 2 diabetes and established atherosclerotic cardiovascular disease, which lasted approximately five years (with a median follow-up of four years). In the trial, 13,299 participants were randomized 1:1 across 640 sites in 30 countries to receive the maximum tolerated dose (MTD) of Mounjaro (5 mg, 10 mg or 15 mg) or Trulicity (1.5 mg) administered subcutaneously once weekly. The primary objective of the trial was to demonstrate that Mounjaro provided a non-inferior reduction in the risk of major adverse cardiovascular events (MACE-3)—a composite of cardiovascular death, heart attack or stroke—compared to Trulicity. SURPASS-CVOT utilized MTD of 5 mg, 10 mg or 15 mg once weekly. The starting dose of 2.5 mg Mounjaro was increased by 2.5 mg every four weeks until MTD was achieved. Participants who tolerated 15 mg continued on 15 mg as their MTD. Participants who tolerated 10 mg but did not tolerate 15 mg continued on 10 mg as their MTD, and participants who tolerated 5 mg but did not tolerate 10 mg continued on 5 mg as their MTD. About REWIND 2019: REWIND NCT01394952 was a multicenter, randomized, double-blind, placebo-controlled trial, published in 2019, designed to assess the effect of Trulicity (1.5 mg) compared to placebo in adults with type 2 diabetes with and without established cardiovascular disease. The primary cardiovascular outcome was the first occurrence of MACE-3. Secondary outcomes include each component of the primary composite cardiovascular outcome, a composite clinical microvascular outcome comprising retinal or renal disease, hospitalization for unstable angina, heart failure requiring hospitalization or an urgent heart failure visit, and all-cause mortality. In the trial, 9,901 participants from 24 countries had a mean duration of diabetes of 10.5 years and a median baseline A1C of 7.2%. About Lilly: Lilly 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.
Web Release
a day ago
- Health
- Web Release
Lilly's Mounjaro (tirzepatide), a GIP/GLP-1 dual agonist, demonstrated cardiovascular protection in landmark head-to-head trial, reinforcing its benefit in patients with type 2 diabetes and heart dise
Eli Lilly and Company (NYSE: LLY) today announced topline results from SURPASS-CVOT, a first-of-its-kind head-to-head Phase 3 cardiovascular outcomes trial comparing two incretin therapies in adults with type 2 diabetes and established atherosclerotic cardiovascular disease. Mounjaro (tirzepatide), a GIP/GLP-1 dual receptor agonist, was compared to Trulicity (dulaglutide), a GLP-1 receptor agonist that showed a definitive cardiovascular benefit in the REWIND study. In SURPASS-CVOT, Mounjaro achieved the primary objective by demonstrating a non-inferior rate of major adverse cardiovascular events (MACE-3), including cardiovascular death, heart attack or stroke vs. Trulicity. In addition, while not controlled for multiplicity-adjusted type-1 error, Mounjaro showed improvements on key measures of A1C, weight, renal function and all-cause mortality. The trial, which enrolled more than 13,000 participants across 30 countries and lasted more than four and a half years, is the largest and longest study of tirzepatide to date. 'Cardiovascular disease remains the leading cause of death among people living with type 2 diabetes,' said Kenneth Custer, Ph.D., executive vice president and president, Lilly Cardiometabolic Health. 'The SURPASS-CVOT results show that Mounjaro preserved the cardioprotective benefit of Trulicity, a GLP-1 receptor agonist, while providing additional benefits, including greater kidney protection and a reduced overall risk of death. These findings strengthen the case for Mounjaro as a potential front-line treatment for people with type 2 diabetes and cardiovascular disease.' In the trial, the risk of cardiovascular death, heart attack, or stroke was 8% lower for Mounjaro vs. Trulicity (hazard ratio: 0.92; 95.3% CI: 0.83 to 1.01), meeting the prespecified criteria for non-inferiority (upper limit of 95.3% CI of the hazard ratio < 1.05).1,2 Mounjaro showed consistent results across all three components of the MACE-3 composite endpoint. The rate of all-cause mortality was 16% lower for Mounjaro vs. Trulicity (hazard ratio: 0.84; 95.0% CI: 0.75 to 0.94).1,3 A pre-specified indirect comparison analysis of matched patient-level data from the REWIND and SURPASS-CVOT studies found that Mounjaro reduced the risk of MACE-3 by 28% (hazard ratio: 0.72; 95.0% CI: 0.55 to 0.94) and all-cause mortality by 39% (hazard ratio: 0.61; 95.0% CI: 0.45 to 0.82) compared to a putative placebo.3,4 In another key pre-specified analysis of participants with high or very-high risk of chronic kidney disease, Mounjaro slowed eGFR decline by 3.54 mL/min/1.73 m2 at 36 months vs. Trulicity (95.0% CI: 2.57 to 4.50).3,5,6 In the trial, Mounjaro also led to greater improvements in A1C, weight and cardiovascular biomarkers, including lipids and systolic blood pressure, compared to Trulicity.3 The safety and tolerability of Mounjaro and Trulicity were generally consistent with their established profiles. The most commonly reported adverse events in SURPASS-CVOT for both Mounjaro and Trulicity were gastrointestinal-related, generally mild-to-moderate in severity, and mostly resolved after dose escalation was complete. During the trial, 13.3% of participants taking Mounjaro discontinued treatment due to adverse events, compared to 10.2% of participants taking Trulicity.7 Detailed results for SURPASS-CVOT will be presented at the European Association for the Study of Diabetes (EASD) Annual Meeting 2025 in September and published in a peer-reviewed journal. Lilly plans to submit these data to global regulatory authorities by the end of this year.
Euronews
07-08-2025
- Health
- Euronews
Experimental pill helped with weight loss in Eli Lilly trial
An experimental once-daily pill to treat obesity can help people lose a significant amount of weight, according to new data from drugmaker Eli Lilly. The medicine, called orforglipron, belongs to a class of blockbuster weight loss drugs known as glucagon-like peptide-1 (GLP-1) receptor agonists, which work by mimicking a hormone that makes people feel full for longer. Most GLP-1 drugs – like Ozempic, Wegovy, and Mounjaro – must be injected, so pharmaceutical companies have been racing to find alternatives. Lilly's pill may be the first to get there. The company plans to ask regulators to approve orforglipron by the end of the year, and said it is ready to begin rolling out the medicine globally. If it's approved, the pill could offer 'a convenient alternative to injectable treatments,' Kenneth Custer, executive vice president and president of Lilly Cardiometabolic Health, said in a statement. The clinical trial included more than 3,100 adults who were overweight or obese and had a weight-related health problem other than patients with diabetes. After 72 weeks, the participants taking 36mg of orforglipron per day lost an average of 12.4 kilograms, or 12.4 per cent of their body weight. Notably, that is not as much as people on other anti-obesity medicines. In one study, for example, people taking Novo Nordisk's Wegovy lost 13.2 per cent of their weight and those on Lilly's Zepbound lost 20.2 per cent over 72 weeks. But the ability to take orforglipron as a daily pill rather than an injectable jab may drive up demand. In the study, other cardiovascular risk factors also improved for patients, including their cholesterol, triglycerides, and blood pressure. Orforglipron's side effects were mostly gastrointestinal, for example, constipation, diarrhoea, and vomiting, similar to other weight loss drugs. Simon Cork, a senior lecturer in physiology at Anglia Ruskin University in the United Kingdom, said the findings are a 'positive step forward in the development of these class of drugs'. Eli Lilly reported the data in a news release, and it has not yet been published in a peer-reviewed journal. The company said it will release more details next month at the European Association for the Study of Diabetes (EASD). "Obesity is one of the most pressing global health challenges of our time, driving global chronic disease burden and impacting more than one billion people worldwide," Custer said.
Yahoo
07-08-2025
- Health
- Yahoo
Daily oral GLP-1 pill could be just as effective as weekly shots: Drugmaker
Drugmaker Eli Lilly says its oral, daily GLP-1 pill may offer similar weight loss results as weekly GLP-1 shots. Eli Lilly said Thursday that the company's orforglipron pill can offer up to an average of 27.3 pounds of weight loss, according to results from two of its Phase 3 trials that included more than 3,000 overweight or obese adults. "With orforglipron, we're working to transform obesity care by introducing a potential once-daily oral therapy that could support early intervention and long-term disease management, while offering a convenient alternative to injectable treatments," Kenneth Custer, an executive vice president and president of Lilly Cardiometabolic Health, said in a statement. "With these positive data in hand, we are now planning to submit orforglipron for regulatory review by year-end and are prepared for a global launch to address this urgent public health need." This is a developing story. Please check back for updates. Solve the daily Crossword
07-08-2025
- Health
Daily oral GLP-1 pill could be just as effective as weekly shots: Drugmaker
Eli Lilly announced Phase 3 trials results for its daily, oral GLP-1 drug. 2:15 Drugmaker Eli Lilly says its oral, daily GLP-1 pill may offer similar weight loss results as weekly GLP-1 shots. Eli Lilly said Thursday that the company's orforglipron pill can offer up to an average of 27.3 pounds of weight loss, according to results from two of its Phase 3 trials that included more than 3,000 overweight or obese adults. "With orforglipron, we're working to transform obesity care by introducing a potential once-daily oral therapy that could support early intervention and long-term disease management, while offering a convenient alternative to injectable treatments," Kenneth Custer, an executive vice president and president of Lilly Cardiometabolic Health, said in a statement. "With these positive data in hand, we are now planning to submit orforglipron for regulatory review by year-end and are prepared for a global launch to address this urgent public health need."
