Genentech reports Phase 2 ZUPREME-1 weight loss trial met primary endpoint

Genentech, a member of the Roche Group (RHHBY), announced positive topline results from the Phase II ZUPREME-1 trial evaluating investigational petrelintide versus placebo in 493 people living with overweight and obesity in a gender-balanced trial population. The study met its primary endpoint, demonstrating that once-weekly subcutaneous injections of petrelintide, escalated every fourth week, resulted in statistically significant and clinically meaningful weight loss from baseline after 28 weeks in all five treatment arms compared to placebo. The weight loss was sustained through week 42 with participants achieving up to 10.7% mean weight loss from baseline using the efficacy estimand, compared to 1.7% with placebo. In the cohort that achieved the greatest reduction in body weight, 98% of trial participants treated with petrelintide reached the maintenance dose underscoring its favorable tolerability profile. Accordingly, body weight reduction using the treatment regimen estimand was largely consistent with the efficacy estimand. Notably, female participants lost considerably more weight than male participants in this trial. “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, M.D., Ph.D., 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.”