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
'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.
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Web Release
3 days ago
- Web Release
Lilly's Mounjaro_tirzepatide Photo
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
Web Release
3 days ago
- 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.
Gulf Today
3 days ago
- Gulf Today
To stay on weight-loss drugs, US patients cut doses
Doctors advise most patients on GLP-1 obesity drugs such as Wegovy and Zepbound to stay on them to keep the weight off, but as more US insurers restrict coverage people are trimming costs by stretching doses or forgoing expenditures like vacations to pay for the medication out of pocket. A half dozen doctors who spoke with Reuters said insurance coverage has tightened in 2025 as many employers drop it for the expensive GLP-1 drugs. While patients on these medications are counseled on proper diet and exercise, clinical trials show that people who stop taking these drugs are apt to regain weight. Novo Nordisk's Wegovy and Eli Lilly's Zepbound are weekly injections with US insurer list prices of more than $1,000 a month. For customers willing to pay cash, both drugmakers will ship directly for $499 a month if refills are purchased at fixed intervals. "A significant number of my patients now pay cash," said Dr. Nidhi Kansal, an obesity specialist at Northwestern Medicine in Chicago. "People find a way to scrounge up $6,000 a year, which sucks, because that's a vacation or two." More than a billion people worldwide are obese, according to the U.N. World Health Organization, which has said the GLP-1 drugs could help end the obesity pandemic. A tech industry job change for Yelena Kibasova, a 40-year-old who lives in the Minneapolis area, meant loss of coverage for her Zepbound prescription that helped her achieve and maintain a 150-pound (68-kg) weight loss, reported Reuters. "My new company does not cover GLP-1s, so now I am in a kind of purgatory," Kibasova said. "I stopped doing my nails. I stopped doing my hair. Those things are not as important as me staying at a healthy weight." The doctors interviewed by Reuters said patients once leery about long-term obesity treatment are now more comfortable staying on a drug. The doctors said that conversations about temporary use happen only when a patient is trying to lose a certain amount of weight for issues such as fertility treatment or an organ transplant. These obesity specialists said they are hopeful that competition will help bring down prices as new weight-loss options emerge, including new oral drugs that may be available next year. Lilly last week announced trial results for its easier-to-manufacture pill, which was shown to cut patient weight by 12.4%, a few percentage points less than injected drugs. The company hopes to launch it in August 2026. Kenneth Custer, Lilly's head of cardiometabolic health, told Reuters the pill is being tested in several settings, including as a maintenance therapy. Custer declined to comment on how it might be priced. Dr. Anne Peters, an endocrinologist at Keck Medicine USC in Los Angeles, said it is important that patients who reach their weight-loss goal not stop a prescription "cold turkey," so the dose can be tapered down over several months. Peters said about a third of her patients are able to reduce their dose and maintain weight loss, while the rest need to stay on the medication. An analysis of U.S. pharmacy insurance claims found that nearly two-thirds of patients who started on Wegovy or Zepbound in 2024 were still on the medications a year later. Peters said she uses "every technique in the book" to secure insurance coverage for patients, but noted that a growing number of plans no longer pay for the treatments, and patients have to pay out-of-pocket. US pharmacies supply self-injection pens pre-loaded with doses of Wegovy or Zepbound. Lilly's direct-to-consumer service also offers vials.
