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RecruitingPhase 3

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

Hoffmann-La Roche · with Zealand Pharma · NCT07843485

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
600
US sites recruiting
2
Study start
September 30, 2026
Record last updated
October 7, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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).

Being studied: Petrelintide; Placebo

Conditions: Obesity or Overweight; Type 2 Diabetes

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

Study contacts (from the official record)

  • Reference Study ID Number: CC46369 https://forpatients.roche.com/No attachments to email below. · 888-662-6728 (U.S. and Canada) · global-roche-genentech-trials@gene.com
  • Fastest Response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
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A Phase III Study to Evaluate the Efficacy and Safety of… (NCT07843485) | Bored Studies