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Clinical Trials in the USA / NCT07843485
Recruiting Phase 3

A Phase III Study to Evaluate the Efficacy and Safety of Petrelintide in Participants With Overweight or Obesity and Type 2 Diabetes

NCT07843485 · 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 OverweightType 2 Diabetes

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 and with Type 2 Diabetes (T2D).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Participants with BMI ≥ 27 kg/m² * T2D diagnosis as per World Health Organization (WHO) classification (or other locally applicable standards) with HbA1c ≥ 6.5% to ≤ 10% (48-86 mmol/mol), measured by the central laboratory at screening * Stable treatment with either diet and exercise alone, basal insulin, or selected oral glucose-lowering agents, for at least 90 days prior to and during screening * History of at least one self-reported unsuccessful dietary effort to lose body weight Exclusion Criteria: * History or presence of proliferative diabetic retinopathy, or diabetic macular edema * 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 (2)

FacilityCityRegionStatus
Institute for Metabolic Research Los Angeles Los Angeles California Recruiting
Manassas Clinical Research Center Manassas Virginia Recruiting

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Other trials for the same condition

A Study of Dulaglutide (LY2189265) 3.0 mg and 4.5 mg in Pediatric Participants With Type 2 Diabetes Mellitus (AWARD-PEDS PLUS) Recruiting
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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 NCT07843485 on ClinicalTrials.gov ↗ ← All trials in the USA