Regeneron adds two olatorepatide Phase 2 obesity trials after Chinese Phase 3 reports 19.3% weight loss
A second dual GLP-1/GIP weight-loss drug is moving into US testing, but it remains years from any possible approval and is not available to patients outside trials.
Two Phase 2 studies of olatorepatide, Regeneron's dual GLP-1/GIP obesity drug licensed from Hansoh Pharma, are now listed on the US clinical trial registry, according to registry monitoring. One is a 360-participant trial in adults with overweight or obesity who do not have diabetes, listed as recruiting, and the other is a 120-participant US study listed as active but not recruiting [1].
Registry monitoring tracks clinical trial records over time, because sites such as ClinicalTrials.gov overwrite a record when it changes and keep no public history of what it used to say [1].
What the Chinese Phase 3 found
The Phase 3 trial, NCT06839664, enrolled 604 adults with obesity or overweight at 33 clinical sites in mainland China. Participants were assigned at random in a 1:1:1:1 ratio to once-weekly olatorepatide at 5 mg, 10 mg or 15 mg, or to placebo, for 48 weeks of treatment [2].
The study met its two primary goals: a statistically significant reduction in body weight compared with placebo, and a significantly higher share of participants losing at least 5% of body weight at week 48 [2]. Mean weight loss reached up to 19.3% from baseline, and 97.2% of participants lost at least 5% [2].
Investigators said body weight was still trending downward at week 48, which they said suggests longer treatment could lead to further weight loss [2]. That was a statement about the direction of the data, not a demonstrated result beyond 48 weeks.
Tolerability and ownership
Average nausea incidence was below 10%, and vomiting occurred in fewer than 5% of participants. Rates of gastrointestinal side effects and treatment discontinuations were lower than those reported in previously published Phase 3 trials of other dual incretin therapies [2].
Eliza Sun, an executive director at Hansoh Pharma, said the drug's dual-target design delivers strong weight-loss efficacy alongside improved gastrointestinal tolerability, a profile she said could support better long-term adherence for people with overweight or obesity [2]. George D. Yancopoulos, president and chief scientific officer at Regeneron, said the results highlight the therapy's efficacy and tolerability potential, and the company plans to move olatorepatide into a registrational development program later this year [2].
Hansoh holds development and commercialization rights in Greater China. Regeneron holds exclusive rights outside mainland China, Hong Kong and Macau under an in-licensing agreement [2]. Regeneron says it is also pursuing approaches designed to preserve muscle mass during weight reduction and to target obesity-related metabolic diseases [2].
Why it matters for patients
Olatorepatide is not approved, and its safety and efficacy have not been evaluated by regulatory authorities [2]. It cannot be prescribed in the US, and the only way to receive it is through a clinical trial.
If approved, it would join the dual GLP-1/GIP class that already includes tirzepatide, sold as Mounjaro and Zepbound. The reported tolerability numbers matter because gastrointestinal side effects are a common reason people stop taking incretin drugs, and the study authors compared their discontinuation rates with those of other dual incretin trials [2].
One limit: the Phase 3 data come from adults in mainland China. Whether the same weight-loss and tolerability results would appear in US patients has not been reported [2]. Detailed results have not yet been published in a peer-reviewed journal, so the full data set has not been independently reviewed [2].
What happens next
Regeneron plans to advance olatorepatide into a registrational development program later this year, meaning 2026 [2]. Detailed Phase 3 data are expected to be presented at an upcoming international medical meeting and submitted for publication; no dates have been disclosed [2]. The trial was led by Prof. Li-Nong Ji of the Department of Endocrinology at Peking University People's Hospital [2].
For the two Phase 2 studies, enrollment is listed at 360 and 120 participants [1]. Doses, treatment duration, endpoints and estimated completion dates have not been reported.
Sources
Semaglutides.org provides information only, not medical advice. Talk to a licensed provider about your own care before making changes. Some telehealth links are affiliate links and are labeled where they appear.