A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Once Weekly Petrelintide vs. Placebo in Participants With Overweight or Obesity

Hoffmann-La Roche

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

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed 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

Interventions

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

Locations (3)

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

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Once Weekly Petrelintide vs. Placebo in Participants With Overweight or Obesity

Summary

Eligibility

Interventions

Locations (3)

Run this study?

Details

Conditions