Global healthcare giant Roche has said its experimental obesity treatment petrelintide delivered significant weight-loss results in a mid-stage clinical trial, strengthening the drugmaker’s push into the fast-growing obesity treatment market.

 

The company announced positive topline data from the Phase II ZUPREME-1 trial, which tested the once-weekly injectable therapy in 493 people living with overweight or obesity with an average body mass index of 37 kg/m². 

 

The randomized, placebo-controlled study met its primary endpoint, showing that patients receiving petrelintide achieved statistically significant and clinically meaningful weight loss after 28 weeks compared with those on placebo.

 

Weight loss continued through week 42, with participants recording up to 10.7% average weight loss from baseline, compared with 1.7% for placebo, according to the company. In the group with the greatest reduction in body weight, 98% of participants reached the maintenance dose, highlighting the drug’s tolerability.

 

“Petrelintide achieved meaningful weight loss with a well-tolerated dosing approach, which is essential to support long-term and sustained benefits in people living with obesity,” said Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development. “Therefore, these data reinforce our confidence in petrelintide’s potential to address important unmet medical needs in chronic weight management.”

 

The trial population was gender-balanced, but results showed female participants lost considerably more weight than male participants.

 

Safety results also appeared encouraging. Researchers reported no unexpected safety signals, and the rate of treatment discontinuation due to adverse events was 4.8% in the most effective petrelintide group, roughly in line with 4.9% for placebo.

 

Most side effects were mild and gastrointestinal-related. Vomiting rates were lower than placebo, with no cases reported in the most effective treatment arm. Diarrhea and constipation occurred at single-digit rates comparable to placebo, while nausea was less frequent than in earlier trials and largely disappeared once patients reached maintenance dosing.