(MENAFN- GlobeNewsWire - Nasdaq) Patients treated with olatorepatide achieved up to 19% body-weight loss at week 48 Regeneron's global Phase 3 registrational program to be initiated later this year
TARRYTOWN, N.Y., March 09, 2026 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced Hansoh Pharmaceutical Group Company Limited has shared positive topline data from its Phase 3 trial in Chinese patients evaluating olatorepatide for the treatment of adults with obesity or who are overweight. Olatorepatide is a novel dual GLP-1/GIP receptor agonist for which Regeneron has exclusive clinical development and commercial rights outside of the Chinese Mainland, Hong Kong and Macau as part of a strategic in-licensing agreement.
The Phase 3 randomized, double-blind, placebo-controlled trial conducted by Hansoh enrolled 604 adults across 33 clinical sites in mainland China and evaluated once-weekly olatorepatide compared to placebo for 48 weeks. The study assessed four cohorts, including 5 mg, 10 mg or 15 mg olatorepatide and placebo. The trial met its co-primary endpoints, demonstrating that olatorepatide compared to placebo led to a statistically significant reduction in body weight from baseline, and also a statistically significant greater proportion of participants who achieved at least 5% weight loss at 48 weeks. Participants treated with olatorepatide achieved up to a 19% mean weight loss from baseline at week 48. Responder analyses showed that up to 97% of participants achieved ≥5% weight loss at week 48.
Olatorepatide demonstrated a favorable gastrointestinal tolerability in the trial, with lower rates of gastrointestinal adverse events and treatment discontinuation relative to those reported in other published Phase 3 dual incretin trials. The average incidence of nausea was below 10%, and the average incidence of vomiting below 5%.
“We are encouraged by the olatorepatide Phase 3 results in this Chinese population, which demonstrate not only meaningful weight loss but also a tolerability profile that could make a real difference in patients' day-to-day experience on treatment,” said George D. Yancopoulos, M.D., Ph.D., Board co-Chair, President, and Chief Scientific Officer at Regeneron.“We are on track to advance into our registrational program later this year and are eager to see the results from our pivotal trials.”
Detailed data from the trial are planned to be presented at an upcoming medical meeting. The safety and efficacy of olatorepatide have not been evaluated by any regulatory authority.
Hansoh holds the development and commercialization rights for olatorepatide in Greater China, while Regeneron holds the rights for development and commercialization outside Greater China.
About the Phase 3 Trial
Hansoh conducted the Phase 3 randomized, double-blind, placebo-controlled, multicenter trial across 33 clinical sites in mainland China and provided the data analysis for the results. The trial enrolled 604 adults with obesity or who were overweight, and who were randomized 1:1:1:1 across four cohorts – including 5 mg, 10 mg or 15 mg olatorepatide or placebo – to evaluate the efficacy and safety of once-weekly olatorepatide, compared to placebo, over 48 weeks.
About Regeneron in Obesity
Obesity is a complex, multifaceted disease and a growing public health concern that affects more than a billion people worldwide. At Regeneron, we are developing a pipeline focused on the quality of weight reduction. We have several independent approaches focused on promoting and preserving muscle during weight loss, so as to increase the amount of fat loss, since adiposity is the principal driver of comorbidities and metabolic diseases associated with obesity. In addition, Regeneron has an extensive pipeline of agents to address some of these co-morbidities and metabolic diseases, which have the potential to be combined with GLP-1RAs. The combination of our science, pipeline, research and clinical innovation uniquely positions us to make a meaningful difference in obesity and obesity-related diseases.
About Regeneron
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases.
Regeneron pushes the boundaries of scientific discovery and accelerates drug development using our proprietary technologies, such as VelociSuite®, which produces optimized fully human antibodies and new classes of bispecific antibodies. We are shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center® and pioneering genetic medicine platforms, enabling us to identify innovative targets and complementary approaches to potentially treat or cure diseases.
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This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (“Regeneron” or the“Company”), and actual events or results may differ materially from these forward-looking statements. Words such as“anticipate,”“expect,”“intend,”“plan,”“believe,”“seek,”“estimate,” variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. 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