Petrelintide for weight management in adults with overweight/obesity and type 2 diabetes
Official title: 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
Run by Hoffmann-La Roche · NCT07843485 · Data updated 2026-11-12
This study tests whether petrelintide, added to a reduced-calorie diet and more physical activity, helps people with overweight or obesity and type 2 diabetes lose weight more effectively than a placebo.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 600 (estimated) |
| Sponsor | Hoffmann-La Roche Industry-sponsored |
| Locations | 2 sites (Los Angeles, California and 1 other locations) |
| Status | Recruiting |
| Started | October 9, 2026 |
| Main results expected | October 20, 2028 |
| Study ends | January 19, 2029 |
| Registry record updated | November 5, 2026 |
| Trial ID | NCT07843485 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with BMI ≥ 27 kg/m², diagnosed type 2 diabetes (HbA1c 6.5%–10%), on stable diet/exercise or certain diabetes medications for at least 90 days, with prior unsuccessful weight-loss attempts.
✕Probably not a fit
Patients with advanced diabetic eye disease or prior exposure to amylin analogs may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized, placebo-controlled Phase 3 trial evaluates the safety and efficacy of petrelintide in adults with overweight or obesity and type 2 diabetes. Participants receive petrelintide or placebo alongside a structured lifestyle program aimed at weight loss, with stable diabetes management for at least 90 days prior to screening. The study uses a central lab to confirm HbA1c and monitors changes in body weight and metabolic measures over time. Eligible participants have a BMI of 27 kg/m² or higher, HbA1c between 6.5% and 10%, and a history of limited success with previous weight-loss attempts. Exclusion criteria include certain advanced diabetic eye diseases and prior use of amylin analogs.
Why it matters
Potential benefit: If successful, participants may achieve greater weight loss and improved metabolic control while maintaining diabetes therapy.
How similar studies have gone: Past studies of peptide-based weight-loss therapies in similar populations have shown modest to meaningful weight reduction when paired with lifestyle changes; this trial tests a comparable approach with petrelintide.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Institute for Metabolic Research Los Angeles
Los Angeles, California, United States Recruiting -
Manassas Clinical Research Center
Manassas, Virginia, United States Recruiting
Study contacts
- Study coordinator: Reference Study ID Number: CC46369 https://forpatients.roche.com/No attachments to email below.
- Email: global-roche-genentech-trials@gene.com
- Phone: 888-662-6728 (U.S. and Canada)
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.