Regeneron-Licensed Olatorepatide Achieves 19% Weight Loss in China Trial
Phase 3 data in 604 Chinese adults treated with olatorepatide showed up to 19% mean weight loss at week 48, with 97% achieving at least 5% reduction. Regeneron holds exclusive global development and commercial rights outside Greater China and plans to initiate its own registrational Phase 3 program later this year.
1. Trial Design and Enrollment
The Phase 3 trial enrolled 604 adults with obesity or overweight across 33 clinical sites in mainland China. Participants were randomized 1:1:1:1 to receive once-weekly 5 mg, 10 mg or 15 mg olatorepatide or placebo over 48 weeks.
2. Efficacy Outcomes
Olatorepatide met both co-primary endpoints by demonstrating a statistically significant reduction in body weight from baseline and a greater proportion of participants achieving at least 5% weight loss. Mean weight loss reached up to 19% at week 48, with 97% of the treatment arms hitting the 5% threshold.
3. Safety Profile
The treatment showed a favorable gastrointestinal tolerability profile, with average nausea incidence below 10% and vomiting under 5%. Discontinuation rates due to adverse events were lower than those reported in other published Phase 3 dual incretin trials.
4. Development Rights and Next Steps
Under the in-licensing agreement, Regeneron holds exclusive development and commercial rights outside Greater China, Hong Kong and Macau. The company plans to launch its global registrational Phase 3 program later this year to support future regulatory submissions.