A Phase III Study to Evaluate the Efficacy and Safety of Petrelintide in Participants With Overweight or Obesity and Established Cardiovascular Disease

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

Enrollment: 2500 planned participants were the target.

It was open to people of any sex aged from 40 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 and established CVD. History of at least one self-reported unsuccessful dietary effort to lose body weight.

The full record lists 2 inclusion and 2 exclusion criteria; among the exclusions: known history of type 1 diabetes mellitus; current or previous treatment with petrelintide or any other amylin analog.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

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.

As a double-blind Petrelintide study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2026-09-30 with completion listed for 2030-07-28.

It ran at 3 sites in United States (3).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Percentage Change in Body Weight from Baseline (time frame: From Baseline to Week 64).

It also tracked 42 secondary outcomes, for example Change from Baseline in Waist Circumference (cm), Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP), Change from Baseline in Triglycerides, Change from Baseline in High-Density Lipoprotein (HDL) Cholesterol, Change from Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials (IWQoL-Lite-CT) Physical Functioning Composite Score and Change from Baseline in Short Form (36) Health Survey Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Petrelintide in 2500 people.

With 2500 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.