Regeneron reports Phase 3 topline results showing up to 19.3% weight loss with dual GLP-1/GIP agonist olatorepatide in obesity trial conducted by Hansoh Pharma in China.
Written By: Samiksha Jadhav BPharm
Reviewed By: Pharmacally Editorial Team
Regeneron Pharmaceuticals has reported positive topline results from a Phase 3 clinical trial evaluating olatorepatide, a dual GLP-1/GIP receptor agonist being developed for adults with obesity or overweight. The study was conducted in China by Hansoh Pharmaceutical Group, which holds development and commercialization rights for the therapy in Greater China, while Regeneron retains exclusive rights outside mainland China, Hong Kong and Macau under a strategic in-licensing agreement.
George D. Yancopoulos, MD, PhD, Board Co-Chair, President and Chief Scientific Officer at Regeneron, said the results highlight both the efficacy and tolerability potential of the therapy in obesity treatment. The company plans to advance olatorepatide into a registrational development program later this year as part of its broader obesity pipeline.
The randomized, double-blind, placebo-controlled Phase 3 trial (NCT06839664) enrolled 604 adults across 33 clinical sites in mainland China. Participants were randomized in a 1:1:1:1 ratio to receive once-weekly olatorepatide at doses of 5 mg, 10 mg or 15 mg, or placebo over a 48-week treatment period.
The study met its co-primary endpoints, demonstrating statistically significant reductions in body weight compared with placebo and a significantly higher proportion of participants achieving at least 5% weight loss at week 48. Patients treated with olatorepatide achieved up to 19.3% mean weight loss from baseline, while 97.2% of participants achieved at least 5% weight reduction during the study period.
According to investigators, body weight reduction was still trending downward at week 48, suggesting that continued treatment could potentially lead to further weight loss beyond the duration of the study.
Olatorepatide also demonstrated a favourable gastrointestinal tolerability profile. The average incidence of nausea was below 10%, while vomiting occurred in fewer than 5% of participants. Rates of gastrointestinal adverse events and treatment discontinuations were lower compared with those reported in previously published Phase 3 trials of other dual incretin therapies.
The trial was led by Prof. Li-Nong Ji from the Department of Endocrinology at Peking University People’s Hospital. Detailed data from the study are expected to be presented at an upcoming international medical meeting and submitted for publication in a peer-reviewed journal.
Eliza Sun, Executive Director at Hansoh Pharma, said olatorepatide’s dual-target design delivers strong weight-loss efficacy while showing improved gastrointestinal tolerability, with nausea below 10% and vomiting below 5%, a profile that could support better long-term treatment adherence in people with overweight or obesity.
Olatorepatide is part of Regeneron’s broader strategy to address obesity through therapies aimed at improving the quality of weight loss, including approaches designed to preserve muscle mass during weight reduction and target obesity-related metabolic diseases. The safety and efficacy of olatorepatide have not yet been evaluated by regulatory authorities.
Reference
Olatorepatide Obesity Treatment Licensed by Regeneron Demonstrates Positive Phase 3 Results in Chinese Patients, 09 March 2026, Olatorepatide Obesity Treatment Licensed by Regeneron Demonstrates Positive Phase 3 Results in Chinese Patients | Regeneron Pharmaceuticals Inc.
Olatorepatide (Hs-20094) Achieves Up To 19.3% Weight Loss At Week 48 In Phase 3 Study With Favourable Gastrointestinal Tolerability, 07 March 2026, Olatorepatide (HS-20094) Achieves Up to 19.3% Weight Loss at Week 48 in Phase 3 Study with Favorable Gastrointestinal Tolerability-Press Releases-Hansoh Pharmaceutical Group Co., Ltd.
A Study of HS-20094 in Chinese Adults with Overweight or Obesity, ClinicalTrials.gov ID NCT06839664, https://clinicaltrials.gov/study/NCT06839664
About the Writer
Samiksha Vikram Jadhav is a B.Pharm graduate with a strong academic foundation in pharmaceutical sciences, pharmacology, and drug development. She has a keen interest in healthcare advancements, clinical research, medical writing, and emerging therapies. Her work focuses on presenting developments in the pharmaceutical and healthcare sectors through clear and accurate scientific communication.