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
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