Regeneron's GLP-1/GIP obesity drug succeeds in late-stage trial

Regeneron said today that its dual GLP-1/GIP receptor agonist asset, licensed from Hansoh Pharmaceutical, helped Chinese patients with obesity lose up to 19% of their body weight in a phase 3 trial.

In Hansoh's study, three doses of olatorepatide (5, 10 and 15 mg) were tested against a placebo in more than 600 adults across 33 clinics in mainland China. The trial met its co-primary endpoints, demonstrating that up to 97% of patients taking the China-developed drug achieved at least 5% weight loss, according to Regeneron's press release.

The weight loss results come close to Zepbound's phase 3 Surmount-1 data, in which patients taking 15 mg of Eli Lilly's GLP-1/GIP receptor agonist lost 20.9% of their body weight after 72 weeks. But as a newcomer to the obesity space, Regeneron may need to deliver more than Zepbound-level results to capture a significant share of the global weight loss market, which is projected to hit $150 billion by 2035.

Regeneron suggests olatorepatide may deliver that edge. The therapy showed a favorable gastrointestinal (GI) tolerability profile, with lower rates of nausea, vomiting and treatment discontinuation than those reported in other late-stage dual incretin trials, the company said.

Because GI side effects are a common cause of discontinuation with GLP-1-based obesity therapies, this improved tolerability could help patients stay on treatment longer and achieve more sustained weight loss.

In the China trial, fewer than 10% of patients taking olatorepatide reported nausea, and under 5% experienced vomiting. In comparison, nausea and vomiting occur in up to 28% and 13% of patients taking Lilly's Zepbound, respectively.

More detailed data is expected to be announced at an "upcoming medical meeting," Regeneron said. The company is also on track to begin a global phase 3 registrational program for olatorepatide this year.

Last June, Regeneron paid $80 million upfront for Hansoh's obesity candidate. Under the licensing deal, Regeneron gained exclusive clinical development and commercialization rights to olatorepatide outside of mainland China, Hong Kong and Macau.

Regeneron is not the only Big Pharma company to turn to dealmaking in China to beef up its GLP-1 pipeline. Pharma giants Novo Nordisk and Pfizer also made sizable deals with Chinese drugmakers last year.

Alivia Kaylor is a scientist and the senior site editor of Pharma Life Sciences.