Eli Lilly and Co (NYSE:LLY) on Thursday shared topline results from the Phase 3 TRIUMPH-4 trial evaluating the two highest investigational doses of retatrutide.
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Retatrutide is a GIP, GLP-1, and glucagon triple hormone receptor agonist, in adults with obesity or overweight and knee osteoarthritis, and without diabetes.
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.
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Targeting Other Ailments
For the co-primary endpoints, retatrutide lowered weight by up to an average of 28.7% and reduced pain by up to an average of 4.5 points (75.8%).
In addition to secondary endpoints, retatrutide reduced known markers of cardiovascular risk.
At the highest dose, data showed that systolic blood pressure was lowered by 14.0 mmHg.
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.
Side Effects
Consistent with the types of adverse events seen in clinical trials for other incretins, the most common adverse events among participants treated with retatrutide were nausea, diarrhea, constipation, vomiting, and decreased appetite
Discontinuation rates due to adverse events were 12.2% and 18.2% with retatrutide 9 mg and 12 mg, respectively, compared to 4.0% with placebo.
Additional results from the TRIUMPH program, which include a maintenance dose of 4 mg in addition to the 9 mg and 12 mg doses tested in this trial, are expected in 2026.
On Wednesday, Eli Lilly announced plans to invest more than $6 billion in a new manufacturing facility in Huntsville, Alabama. The site will be among those that will manufacture orforglipron, Eli Lilly's first oral, small molecule GLP-1 receptor agonist, which the company expects to submit to global regulatory agencies for obesity by the end of this year.
LLY Price Action: Eli Lilly shares were up 1.50% at $1008.56 at the time of publication on Wednesday, according to Benzinga Pro data.
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