Phase III Trial Shows Olatorepatide Achieved 19.3% Weight Loss
Hansoh Pharma's dual GLP-1/GIP receptor agonist, olatorepatide, demonstrated significant weight reduction and good gastrointestinal tolerability in a 48-week Phase III study presented at EASD.
Milan – Hansoh Pharma announced results from its Phase III LIGHTEN study of olatorepatide, a dual GLP-1/GIP receptor agonist, at the European Association for the Study of Diabetes (EASD) Annual Meeting. The study evaluated the efficacy and safety of olatorepatide for weight management in adults with overweight or obesity.
The multicenter, randomized, double-blind, placebo-controlled trial involved 604 Chinese adults. Participants were assigned to receive once-weekly subcutaneous injections of olatorepatide at doses of 5 mg, 10 mg, or 15 mg, or placebo for 48 weeks. Key endpoints included percentage change in body weight and the proportion of participants achieving at least 5% weight loss.
Results showed that the 15 mg dose of olatorepatide led to a mean weight loss of 19.3% after 48 weeks, compared to 2.7% in the placebo group. Waist circumference also decreased significantly by an average of 16.0 cm in the 15 mg group. The study reported a low incidence of gastrointestinal adverse events, with nausea occurring in 7.8% and vomiting in 4.9% of participants receiving olatorepatide. Notably, the weight loss trend continued without plateauing, suggesting further benefits with longer treatment.
Olatorepatide also demonstrated improvements in metabolic parameters, including blood pressure, lipid profiles, and HbA1c. The overall safety profile was consistent with incretin therapies approved for weight management, and no treatment discontinuations due to adverse events were reported. Hansoh Pharma highlighted olatorepatide's potential as a new therapeutic option for weight management due to its efficacy and favorable tolerability.