‘We now have the clinical data package to support global submissions for retatrutide as a potential treatment for obesity, knee osteoarthritis pain, and obstructive sleep apnea.’
Key takeaways:
- Retatrutide met primary endpoints in the TRIUMPH-2 and TRIUMPH-3 trials, delivering substantial weight loss at 80 weeks.
- The clinical data package will support global submissions for the drug as a potential treatment for obesity, knee osteoarthritis pain, and obstructive sleep apnea.
- Eli Lilly plans to submit a Biologics License Application to the FDA in Q1 2027.
Eli Lilly and Company recently shared positive topline results from two pivotal phase 3 trials evaluating retatrutide, an investigational, first-in-class GIP, GLP-1, and glucagon triple hormone receptor agonist.
The results from the TRIUMPH-2 and TRIUMPH-3 studies provide a clinical data package to support global regulatory submissions for retatrutide as a potential treatment for obesity, knee osteoarthritis pain, and obstructive sleep apnea.
“Across five positive phase 3 studies, retatrutide has shown powerful efficacy, and we believe it could be an important future tool in the management of cardiometabolic health,” says Kenneth Custer, PhD, executive vice president and president, Lilly Cardiometabolic Health, in a release. “With the positive results from TRIUMPH-2 and TRIUMPH-3, we now have the clinical data package to support global submissions for retatrutide as a potential treatment for obesity, knee osteoarthritis pain, and obstructive sleep apnea. We look forward to working with regulators as they evaluate this first-of-its-kind medicine.”
In the TRIUMPH-2 trial, adults with obesity or overweight and type 2 diabetes lost up to an average of 49.6 lbs (20.8%) at 80 weeks on the highest studied dose (12 mg). The trial evaluated three doses (4 mg, 9 mg, and 12 mg), all of which delivered substantial weight loss and improved glycemic control compared to placebo.
In the TRIUMPH-3 trial, adults with severe obesity and established cardiovascular disease, with or without type 2 diabetes, lost up to an average of 55.8 lbs (22.6%) at 80 weeks on the highest dose. The study also found that major adverse cardiovascular events occurred less frequently in participants taking retatrutide compared to the placebo group. Retatrutide meaningfully reduced certain cardiovascular risk factors, delivering average reductions in triglycerides, non-HDL cholesterol, and systolic blood pressure.
The most common adverse events reported with retatrutide in both trials included diarrhea, nausea, constipation, decreased appetite, and vomiting. These events were generally mild to moderate, and the majority resolved during treatment.
Detailed results from TRIUMPH-2 and TRIUMPH-3 will be presented at future medical meetings and published in peer-reviewed journals. Eli Lilly plans to submit a Biologics License Application for retatrutide to the FDA in Q1 2027 for US approval.
