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

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 and Type 2 Diabetes

Who can join

Ages 18 and older · All sexes

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

About the study

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).

What is being tested

• Petrelintide (combination product)
• Placebo (combination product)

Sponsor: Hoffmann-La Roche · Participants: 600 · Started: Oct 9, 2026

Contact the study team

• Reference Study ID Number: CC46369 https://forpatients.roche.com/No attachments to email below. · Phone: 888-662-6728 (U.S. and Canada)

Official record on ClinicalTrials.gov — NCT07843485

Locations in the U.S.

Conditions

• Obesity
• Overweight
• Type 2 Diabetes

From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.