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Clinical Trials in the USA / NCT07843498
Recruiting Phase 3

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

NCT07843498 · tracked via the Priya Life Science USA tracker
Sponsor
Hoffmann-La Roche
Phase
Phase 3
Started
2026-09-30
Last updated
2026-10-07

Condition(s) studied

Obesity or Overweight

Investigational drug(s) / intervention(s)

PetrelintidePlacebo

Petrelintide: Petrelintide will be administered subcutaneously (SC) using a drug-device combination product.

Placebo: Petrelintide-matching placebo will be administered SC using a drug-device combination product.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Percentage Change in Body Weight from Baseline — From Baseline to Week 64

Trial sites (3)

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

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Other trials for the same condition

A Study to Evaluate Effect of AZD6234 in Adult Participants With Type 2 Diabetes Mellitus and Obesity or Overweight Recruiting
A Phase III Study to Evaluate the Efficacy and Safety of Petrelintide in Participants With Overweight or Obesity and Established Cardiovascular Disease Recruiting
A Study to Evaluate Effect of AZD6234 in Adult Participants With Obesity or Overweight With Weight-related Comorbidity Without Type 2 Diabetes Mellitus Recruiting
Mirikizumab and Tirzepatide Administered in Adult Participants With Moderately to Severely Active Crohn's Disease and Obesity or Overweight Recruiting
A Study to Evaluate Effect of AZD6234 as an Adjunct to Incretin-based Therapies in Adult Participants With Obesity or Overweight With Weight-related Comorbidity With or Without Type 2 Diabetes Mellitus Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07843498 on ClinicalTrials.gov ↗ ← All trials in the USA