RECRUITING Phase 3 ClinicalTrials.gov

A Phase III Study to Evaluate the Efficacy and Safety of Petrelintide in Participants With Overweight or Obesity

Sponsor: Hoffmann-La Roche • ClinicalTrials.gov ID: NCT07843498

Registry updated: 2026-10-07

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Description

This study will evaluate the efficacy and safety of petrelintide compared with placebo, in conjunction with a reduced-calorie diet and increased physical activity, for weight management in participants living with overweight or obesity, at least one weight-related comorbidity, and without Type 2 Diabetes (T2D).

Interventions

Petrelintide (Combination product)
Petrelintide will be administered subcutaneously (SC) using a drug-device combination product.
Placebo (Combination product)
Petrelintide-matching placebo will be administered SC using a drug-device combination product.

Eligibility criteria

Inclusion Criteria: * Participants with BMI ≥ 30 kg/m² or BMI ≥ 27 kg/m² with at least one weight-related comorbidity * History of at least one self-reported unsuccessful dietary effort to lose body weight Exclusion Criteria: * HbA1c ≥ 48 mmol/mol (6.5%), measured by the central laboratory at screening * Known history of Type 1 or Type 2 diabetes mellitus * Current or previous treatment with petrelintide or any other amylin analog

Conditions

Obesity or Overweight

Locations

Pinnacle Research Group — Anniston, Alabama, United States
Progressive Medical Research — Port Orange, Florida, United States
Clinical Research Associates — Nashville, Tennessee, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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