NCT06662539

Once-weekly Petrelintide Versus Placebo for Obesity or Overweight With Co-morbidities

A Randomized, Double-blind, Phase 2, Dose-finding Trial of Once Weekly Petrelintide Compared With Placebo in Participants With Obesity or Overweight With Weight Related Comorbidities

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 493 (actual)
• Sponsor: Zealand Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to compare dose levels of petrelintide versus placebo with regards to effect on body weight, safety, and tolerability.

Detailed description

Obesity is a chronic disease with a rapidly increasing prevalence associated with significant comorbidities. Petrelintide is a long-acting amylin analog in development for weight management. This is a randomized, double-blind, placebo-controlled, parallel-group, multinational, multicenter, dose-finding, Phase 2 clinical trial. The trial will compare 5 doses of once-weekly (OW) subcutaneously administered petrelintide with placebo. This study consists of 3 periods: 1. A screening period of 2-3 weeks 2. A treatment period of 42 weeks 3. A safety follow-up period of 9 weeks.

Conditions

• Obesity

Interventions

Type	Name	Description
DRUG	Petrelintide	Petrelintide will be taken by participants once weekly as a self-administered subcutaneous injection.
DRUG	Placebo	Matching placebo to petrelintide will be taken by participants once weekly as a self-administered subcutaneous injection.

Timeline

• Start date: 2024-12-09
• Primary completion: 2025-09-30
• Completion: 2026-03-07
• First posted: 2024-10-29
• Last updated: 2026-03-23

Locations

32 sites across 3 countries: United States, Poland, Romania

Regulatory

• FDA-regulated drug study