Roche (SWX: ROG, OTCMKTS: RHHBY) announced positive topline results from the Phase II ZUPREME-1 trial evaluating petrelintide in 493 individuals with overweight and obesity (mean BMI 37 kg/m²). Participants achieved up to 10.7% mean weight loss from baseline at week 42 versus 1.7% placebo, demonstrating sustained efficacy for the once-weekly amylin analog acquired through the 2025 Zealand Pharma partnership.
Clinical Trial Results
Endpoint
Petrelintide
Placebo
Treatment Effect
Mean Weight Loss (Week 42)
Up to 10.7%
1.7%
9.0 percentage-point advantage
Analysis Method
Efficacy estimand
—
Accounts for treatment adherence
Study Population
493 participants
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Mean BMI 37 kg/m² (obese)
Duration
42 weeks
—
Sustained weight loss trend
Trial Name
ZUPREME-1 (Phase II)
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Randomized, double-blind, placebo-controlled
Drug Profile & Mechanism
Attribute
Petrelintide Profile
Drug Class
Long-acting amylin analog
Target
Amylin receptor (co-localized with calcitonin receptor in brainstem)
Manufacturing: Peptide-based production scalable; Roche’s biologics capacity supports global supply
Regulatory Pathway: FDA Breakthrough Therapy designation potential given unmet need and novel mechanism
Forward‑Looking Statements This brief contains forward‑looking statements regarding Phase III development timelines, regulatory pathways, and commercial potential for petrelintide. Actual results may differ due to competitive dynamics, safety findings in larger trials, and reimbursement decisions.-Fineline Info & Tech
By Fineline Cube