Eli Lilly said its experimental obesity drug retatrutide met the primary endpoint in the phase 3 TRIUMPH-1 study, helping patients lose up to 28.3% of their body weight over 80 weeks. The late-stage trial results allow the company to seek regulatory approval for the treatment, which Lilly said it hopes to launch next year.
The study evaluated retatrutide, a triple hormone receptor agonist targeting GIP, GLP-1, and glucagon pathways, in patients with obesity but not diabetes. Lilly said all three tested doses met the primary and key secondary endpoints for obesity.
Based on the efficacy estimand, which assessed patients who remained on treatment and did not begin other prohibited weight-loss therapies, those taking the 4 mg dose lost 19% of body weight after 80 weeks. Patients receiving 9 mg lost 25.9%, while those on the 12 mg dose lost 28.3%. Participants on placebo lost an average of 2.2% of body weight under the same measure.
Under the treatment regimen estimand, which measures outcomes regardless of treatment adherence or additional therapies, weight loss figures reached 17.6%, 23.7%, and 25% for the 4 mg, 9 mg, and 12 mg doses, respectively. Patients receiving a placebo lost 3.9% of their weight.
Lilly also reported continued weight reduction beyond Week 80. In a subset of participants who remained on the highest dose through Week 104, weight loss reached 29.9% under the treatment regimen estimand. The company said patients who continued treatment for a full two years lost just over 30% of body weight on average. More than 45% of participants receiving the 12 mg dose lost at least 30% of their body weight.
Kenneth Custer, Lilly’s president of cardiometabolic health, said, “That’s really a threshold that’s historically been associated with bariatric surgery.”
The topline release did not include results on osteoarthritis pain or sleep apnea, despite those outcomes being tracked in the study using the Western Ontario and McMaster Universities Osteoarthritis Index (Womac) and the Apnea-Hypopnea Index (AHI). Week 80 Womac and AHI measurements are among the study’s primary endpoints. Lilly said complete details from the study will be presented at the American Diabetes Association scientific sessions in New Orleans in June.
Analysts gave mixed reactions to the data. Citi analysts said the placebo-adjusted result nominally exceeded Wall Street expectations of 25%, though some observers had anticipated stronger performance. BMO Capital Markets analysts had projected placebo-adjusted weight loss in a range of 27% to 28.5%, although their note did not specify whether the estimate referred to the efficacy or treatment-regimen estimand.
The treatment regimen data are compared with results from other obesity drugs. Lilly’s approved obesity treatment Zepbound previously showed weight loss of up to 20.9%, while Novo Nordisk reported 18.7% for the high dose of Wegovy in separate trials.
Regarding safety, 11.3% of patients receiving the highest dose discontinued treatment because of adverse events, compared with 4.9% of placebo recipients. The low dose recorded a discontinuation rate of 4.1%, lower than placebo, although gastrointestinal adverse events occurred about twice as often as in the placebo group.
Dysesthesia affected 20.9% of patients on the highest dose in an earlier osteoarthritis trial, compared with 12.5% in the latest study, easing some concerns that had followed previous trial data. Shares of Lilly rose about 1% to 1.5% in early Thursday trading following the results.
Retatrutide Shows Strong Results in Obesity Study
Retatrutide has demonstrated impressive results in Eli Lilly’s latest Phase 3 obesity trial, with participants achieving up to 28.3% average weight loss. The findings position Retatrutide as one of the most promising investigational therapies in the growing obesity treatment market.
Retatrutide Highlights Eli Lilly’s Innovation
The success of Retatrutide reflects Eli Lilly’s continued investment in metabolic disease research. Clinical investigators reported that Retatrutide significantly improved weight reduction outcomes when combined with lifestyle interventions during the trial period.
Retatrutide Could Transform Obesity Treatment
Healthcare experts believe Retatrutide may redefine future obesity care because of its high efficacy compared to existing therapies. The Phase 3 data also showed that Retatrutide supported improvements in several metabolic health indicators linked to obesity-related complications.
Safety and Tolerability of Retatrutide
According to trial updates, Retatrutide displayed a manageable safety profile, with most side effects reported as mild to moderate gastrointestinal symptoms. Researchers noted that the overall tolerability of Retatrutide remained consistent with other incretin-based obesity therapies.
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