Once-weekly Petrelintide Versus Placebo for Obesity or Overweight With Co-morbidities

What Was Tested

In this phase 2 trial, researchers set out to test Petrelintide.

It had six arms (groups): one (experimental), one (experimental), one (experimental), one (experimental) and one (experimental).

The registry classes the interventions as drug.

More on the Plan

Petrelintide is a long-acting amylin analog in development for weight management.

This study consists of 3 periods: 1.

A screening period of 2-3 weeks 2.

A treatment period of 42 weeks 3.

Who Took Part

493 actual participants took part.

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: A female participant is eligible to participate if she is:. A woman of nonchildbearing potential. OR. Ability to comply with the protocol requirements including self-administration of IMP with vial and syringe.

The full record lists 5 inclusion and 19 exclusion criteria; among the exclusions: history of type 1 or type 2 diabetes mellitus; treatment with glucose lowering agent(s) within 90 days prior to screening; treatment with any medication (prescribed or over-the-counter) or alternative remedies (herbal or nutritional supplements) intended to promote weight loss within 6 months prior to screening.

How the Study Was Run

Design: randomized, parallel-group and double-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.

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

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

Those kept unaware of assignments: participant and investigator.

It started in 2024-12-09 with completion listed for 2025-09-30.

It ran at 32 sites in United States (19), Poland (7) and Romania (6).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Percent change from baseline in body weight to Week 28 (time frame: From Baseline (Day 1) to Week 28).

It also tracked 11 secondary outcomes, for example Change from baseline in body weight to Weeks 28 and 42, Change from baseline in waist circumference to Weeks 28 and 42, Percent change from baseline in body weight to Week 42, Change from baseline in hemoglobin A1c (HbA1c) to Week 42, Change from baseline in fasting glucose to Week 42 and Change from baseline in high-sensitivity C-reactive protein (hsCRP) to Week 42.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Petrelintide in 493 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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