Roche and Zealand drug shows 9.2% mean body weight reduction
Roche and Zealand Pharma have shared positive topline results from the Phase II ZUPREME-2 trial evaluating petrelintide versus placebo in people living with overweight or obesity and type 2 diabetes.
The trial met its primary endpoint, demonstrating that once-weekly subcutaneous injections of petrelintide (escalated every fourth week) resulted in statistically significant and clinically meaningful reductions in body weight from baseline after 28 weeks.
Study participants achieved up to 9.2% mean weight loss from baseline using the efficacy estimand compared to 2.0% with placebo.
Petrelintide also demonstrated a clinically relevant reduction in HbA1c, with participants achieving a placebo-adjusted HbA1c reduction of 0.61%-0.88%.
“These results further support the potential of petrelintide in chronic weight management and, for the first time, demonstrate its promise as a standalone treatment for those living with overweight or obesity and type 2 diabetes,” said Dr David Kendall, Chief Medical Officer at Zealand Pharma. “These data confirm the potential for clinically meaningful weight reduction with a promising and favourable tolerability profile.
“We are also encouraged by the improvements in glycaemic control – a combination essential for supporting long-term, sustained benefits in people living with obesity and type 2 diabetes. Together with Roche, we look forward to investigating petrelintide in our recently initiated Phase III registrational programme to address important unmet medical needs in chronic weight management.”
No unexpected safety signals were observed with petrelintide treatment, the company reports. The treatment discontinuation rate due to gastrointestinal adverse events was 1.9% for participants treated with petrelintide versus 1.7% with placebo.
Zealand Pharma and Roche have started a Phase IIIa programme which consists of three trials, evaluating once-weekly petrelintide in people with obesity or overweight without type 2 diabetes, people with obesity or overweight with type 2 diabetes, and people with obesity or overweight and established cardiovascular disease.