Phase 3 TRIUMPH-1 trial data show retatrutide reduced the AHI by up to 36.1 events per hour alongside substantial weight loss.
Key takeaways:
- Retatrutide reduced moderate-to-severe OSA severity by up to 36.1 events per hour (60.6%) from a baseline of 58.6 events per hour.
- In the TRIUMPH-1 trial, participants on the highest dose (12 mg) lost an average of 70.3 lbs (28.3%) over 80 weeks, with 65.3% achieving a BMI below 30.
- The findings were presented at the American Diabetes Association 86th Scientific Sessions.
Eli Lilly and Company announced positive results from the pivotal phase 3 TRIUMPH-1 trial of retatrutide, an investigational triple hormone receptor agonist, demonstrating substantial weight loss and meaningful improvements in moderate-to-severe obstructive sleep apnea (OSA).
TRIUMPH-1 included an overarching trial for adults with obesity and two nested basket trials, one of which focused on moderate-to-severe OSA. At 80 weeks, retatrutide met primary endpoints, delivering significant improvements in sleep apnea severity. According to the company, retatrutide reduced the apnea-hypopnea index (AHI) by up to 36.1 events per hour (60.6%) from a baseline of 58.6 events per hour in participants with moderate-to-severe OSA.
Alongside OSA improvements, the trial delivered notable weight loss results. Participants on retatrutide 9 mg and 12 mg lost an average of 64.4 lbs (25.9%) and 70.3 lbs (28.3%), respectively, over 80 weeks. Furthermore, 65.3% of participants on retatrutide 12 mg achieved a BMI below 30, no longer meeting the criteria for obesity.
“Obesity drives more than 200 downstream diseases, yet we have historically treated those conditions one at a time and in silos,” says Ania Jastreboff, MD, PhD, professor of medicine & pediatrics (endocrinology) at the Yale School of Medicine, director of the Yale Obesity Research Center, and lead investigator, in a release. “In TRIUMPH-1 and TRANSCEND-T2D-1, treatment with retatrutide resulted in substantial weight reduction together with clinically meaningful improvements in glycemia, knee osteoarthritis pain, and obstructive sleep apnea, with many individuals reaching what are classified as healthy-range weight and normal blood sugar levels.”
Retatrutide is an investigational once-weekly single molecule that activates the body’s receptors for glucose-dependent insulinotropic polypeptide (GIP), glucagon-like peptide-1 (GLP-1), and glucagon.
“Across TRIUMPH-1 and TRANSCEND-T2D-1, retatrutide delivered substantial weight loss, meaningful A1C reduction, and improvements in knee osteoarthritis pain and moderate-to-severe obstructive sleep apnea, a breadth and magnitude of outcomes that’s striking to see with a single therapy,” says Kenneth Custer, PhD, executive vice president and president, Lilly Cardiometabolic Health, in a release.
The types of adverse events seen in TRIUMPH-1 were generally consistent with trials of other incretin-based therapies. The most common adverse events with retatrutide included nausea, diarrhea, constipation, and vomiting.
The findings from TRIUMPH-1 were presented at the American Diabetes Association 86th Scientific Sessions.
The initial TRIUMPH Phase 3 clinical development program is evaluating the safety and efficacy of retatrutide for the treatment of patients with obesity or overweight, moderate-to-severe OSA and obesity, and knee osteoarthritis pain across four global registrational trials. The program, which began in 2023, has enrolled more than 5,800 participants with additional results anticipated over the next year.
The TRANSCEND-T2D Phase 3 clinical trial program is evaluating the safety and efficacy of retatrutide for the treatment of adults with type 2 diabetes across three global registrational trials. The program, which began in 2024, has enrolled more than 2,050 participants and additional results are anticipated over the next year.
