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NCT07843498PHASE3Recruiting

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

Hoffmann-La Roche

Start Date

9/30/2026

Completion Date

3/22/2029

Summary

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).

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

COMBINATION_PRODUCT

Petrelintide

COMBINATION_PRODUCT

Placebo

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Conditions

Obesity or Overweight

Locations

Pinnacle Research Group

Anniston, Alabama 36207

United States

Progressive Medical Research

Port Orange, Florida 32127

United States

Clinical Research Associates

Nashville, Tennessee 37203

United States