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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

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

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well petrelintide works for weight control and how safe it is in people with overweight or obesity and type 2 diabetes. It compares petrelintide with a placebo, which has no active drug. Both groups will also eat fewer calories and be more physically active.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have a body mass index (BMI) of 27 or higher. BMI is a measure of weight compared with height.
  • Have type 2 diabetes and an HbA1c of 6.5% to 10% on the study lab's screening test. HbA1c measures average blood sugar.
  • Have stable diabetes treatment for at least 90 days before screening and during screening. Allowed treatments are diet and exercise alone, basal insulin (background insulin), or certain blood sugar pills.
  • Report at least one past attempt to lose weight through diet that did not work.

Who can't join

  • Have or have had proliferative diabetic retinopathy (abnormal blood vessel growth in the back of the eye) or diabetic macular edema (swelling in the part of the eye used for sharp vision).
  • Use or have used petrelintide or another amylin analog, a drug that acts like the hormone amylin.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (2)

CA

VA