Roche Advances Obesity Pipeline as Petrelintide Meets Phase II Goal

Roche RHHBY has announced that the mid-stage study ZUPREME-1, evaluating the investigational candidate petrelintide for the treatment of obesity, met its primary endpoint.

The drug is being co-developed with Zealand Pharma (ZEAL), expanding Roche’s exposure to the high-growth obesity therapeutics market.

Petrelintide is an investigational long-acting amylin analog suitable for once-weekly subcutaneous administration.

In the past six months, Roche’s shares have gained 27.6% compared with the industry’s 20.4% growth.

More on RHHBY & ZEAL’s Obesity Drug

The phase II ZUPREME-1 study is a randomized, double-blind, placebo-controlled, dose-finding study evaluating investigational petrelintide versus placebo in 493 people living with overweight and obesity (mean BMI of 37 kg/m²) in a gender-balanced trial population.

Top-line results from the study showed that it 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.

Petrelintide delivered up to 10.7% mean weight loss at week 42, significantly outperforming placebo (1.7%).

The candidate also demonstrated placebo-like tolerability, with no vomiting cases and no treatment discontinuations due to gastrointestinal adverse events at the highest effective dose.

In the cohort showing the greatest weight reduction, 98% of participants treated with petrelintide successfully reached the maintenance dose, highlighting the drug’s strong tolerability and supporting its potential for sustained use in chronic weight management.

The strong efficacy and favorable safety profile support further development of petrelintide as both a standalone treatment and a combination therapy, highlighting its strategic potential within Roche’s cardiometabolic pipeline.

Per the deal with ZEAL, the two companies are co-developing petrelintide, Zealand Pharma’s amylin analog, as a standalone therapy as well as a fixed-dose combination with Roche’s lead incretin asset, CT-388.

Looking ahead, final results from the ZUPREME-1 study, including a nine-week safety follow-up, will be presented at an upcoming medical meeting and are expected to determine the phase III development strategy for petrelintide.

Top-line data from the second phase II monotherapy study, ZUPREME-2, evaluating petrelintide in patients with obesity or overweight and type II diabetes are anticipated in the second half of 2026. In addition, a phase II trial assessing petrelintide in combination with CT-388 is planned to begin later in 2026.

RHHBY Looking to Capture a Pie in the Obesity Market

Earlier this year, Roche announced positive top-line results from a phase II study of CT-388, an investigational dual GLP-1/GIP receptor agonist being developed for the treatment of obesity.

Results showed that a once-weekly subcutaneous injection of CT-388 achieved a statistically significant placebo-adjusted weight loss of 22.5% at 48 weeks at the highest dose tested (24 mg), without reaching a weight loss plateau.

Although Roche is a late entrant into the highly competitive obesity market — currently dominated by Eli Lilly LLY and Novo Nordisk NVO — the strength of CT-388’s data represents a significant positive development. Phase III obesity trials (Enith1 and Enith2) are expected to commence this quarter.

Eli Lilly currently leads the obesity market with its tirzepatide-based dual GLP-1/GIP receptor agonists, Mounjaro and Zepbound.

Arch rival Novo Nordisk commands a strong position with its semaglutide-based GLP-1 therapies, Ozempic and Wegovy, used in type 2 diabetes and obesity.

Both LLY and NVO generate a major chunk of their total revenues from their respective cardiometabolic drugs.

Roche currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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