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

What Was Tested

This registered phase 3 trial tested Petrelintide.

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

The registry classes the interventions as combination product.

Who Took Part

Enrollment: 3900 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 ≥ 30 kg/m² or BMI ≥ 27 kg/m² with at least one weight-related comorbidity. History of at least one self-reported unsuccessful dietary effort to lose body weight.

The full record lists 2 inclusion and 3 exclusion criteria; among the exclusions: known history of type 1 or type 2 diabetes mellitus; current or previous treatment with petrelintide or any other amylin analog.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

Random assignment meant chance, not the researchers, decided who got Petrelintide and who got the comparison, which limits bias.

The Petrelintide group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Petrelintide.

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

It started in 2026-09-30 with completion listed for 2028-12-21.

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 41 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 3900 people.

With 3900 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.