INDIANAPOLIS (dpa-AFX) - Eli Lilly and Co. (LLY) announced Thursday positive topline results from the Phase 3 TRIUMPH-4 clinical trial evaluating the safety and efficacy of the two highest investigational doses of retatrutide, a first-in-class GIP, GLP-1 and glucagon triple hormone receptor agonist, in adults with obesity or overweight and knee osteoarthritis, and without diabetes, as an adjunct to healthy diet and physical activity.
In this global registration trial, where 84.0% of participants had a baseline BMI of ?35 kg/m², each dose of retatrutide (9 mg and 12 mg) met all primary and key secondary endpoints, delivering significant weight loss and improvements in pain and physical function at 68 weeks using both the efficacy and treatment-regimen estimands.
For the co-primary endpoints, retatrutide lowered weight by up to an average of 28.7% (71.2 lbs) and reduced pain by up to an average of 4.5 points (75.8%) using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score.
In additional secondary endpoints, retatrutide reduced known markers of cardiovascular risk, including non-HDL cholesterol, triglycerides, and high-sensitivity C-reactive protein (hsCRP), and at the highest dose lowered systolic blood pressure by 14.0 mmHg, using the efficacy estimand.
In an additional post-hoc analysis, 14.1% of patients on retatrutide 9 mg and 12.0% patients on retatrutide 12 mg were completely free of knee pain at 68 weeks compared to 4.2% on placebo, based on the observed efficacy estimand data.
For the treatment-regimen estimand, each dose level of retatrutide led to statistically significant improvements in both co-primary and all secondary endpoints.
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