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

What Was Tested

In this phase 3 trial, researchers set out to test Petrelintide.

It had two arms (groups): Petrelintide (experimental) and Placebo (placebo comparator).

The registry classes the interventions as combination product.

Who Took Part

The registry lists 600 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Participants with BMI ≥ 27 kg/m². 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.

The full record lists 4 inclusion and 2 exclusion criteria; among the exclusions: history or presence of proliferative diabetic retinopathy, or diabetic macular edema; current or previous treatment with petrelintide or any other amylin analog.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

Because people in this Petrelintide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on Petrelintide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2026-09-30 with completion listed for 2028-10-20.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Percentage Change in Body Weight from Baseline (time frame: From Baseline to Week 64).

It also tracked 41 secondary outcomes, for example Change from Baseline in Waist Circumference (cm), Change from Baseline in Hemoglobin A1c (HbA1c), Change from Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials (IWQoL-Lite-CT) Physical Functioning Composite Score, Change from Baseline in Short Form (36) Health Survey Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score, Change from Baseline in Mean Daily Food Craving Score and Change from Baseline in Mean Daily Peak Hunger Score.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Petrelintide in 600 people.

With 600 participants it is a large trial for this field.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Petrelintide compound page, all human trials.