NCT07843485RecruitingPhase 3
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
Source: ClinicalTrials.gov · Last updated 7 Oct 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 600 (estimated)
- First submitted
- 11 Sept 2026
- Start date
- 30 Sept 2026
- Primary completion date
- 20 Oct 2028
- Lead sponsor
- Hoffmann-La Roche
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT07843485
- EU CT number
- 2026-526189-25-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 600
- From 30 Sept 2026 to the primary completion date, 20 Oct 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current or previous treatment with petrelintide or any other amylin analog
Other
- History or presence of proliferative diabetic retinopathy, or diabetic macular edema
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institute for Metabolic Research Los Angeles Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Manassas Clinical Research Center Coordinator of this site? Confirm its status | Manassas | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.