Pharmacokinetics of Petrelintide Following Administration to Participants With Impaired Renal Function

What Was Tested

In this phase 1 trial, researchers set out to test Petrelintide.

This clinical research study is testing the study compound petrelintide that is being developed for the weight management in people with obesity or overweight with comorbidities or related diseases.

The aim of this clinical research study is to investigate whether the effects of petrelintide will be different in people with normal kidney function compared to people with impaired kidney function.

It had four arms (groups): Group 1 Normal Renal Function (experimental), Group 2 Mild Renal Impairment (experimental), Group 3 Moderate Renal Impairment (experimental) and Group 4 Severe Renal Impairment (experimental).

The registry classes the interventions as drug.

More on the Plan

Allocation of participants to the renal function groups will be based on the estimated glomerular filtration rate (eGFR).

Up to 24 participants with normal renal function and 24 participants with renal impairment (8 participants each in the following groups: mild, moderate, or severe renal impairment) will participate in this study.

Who Took Part

39 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Age: 18 to 65 years (both inclusive) at screening. BMI (Body Mass Index): 21.0 to 40.0 kg/m2, inclusive, at screening. Sex: Male and female participants. Participants with mild, moderate, or severe renal impairment and participants with normal renal function. For participants with renal impairment: stable renal impairment for 3 months prior to screening.

The full record lists 8 inclusion and 15 exclusion criteria; among the exclusions: exposure to amylin analogs, including petrelintide (zp8396) within the last 3 months; impaired liver function, defined as alanine aminotransferase (alt) \>1.2 times upper normal limit, or bilirubin \>1.2 times upper normal limit, measured at screening; presence or history of acute or chronic pancreatitis.

How the Study Was Run

Design: non-randomized, parallel-group and double-blind.

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 and outcomes assessor.

It started in 2025-04-15 with completion listed for 2025-11-25.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: AUCo-inf of petrelintide (time frame: From administration (Day 1) to Last visit (Day 43)).

It also tracked 7 secondary outcomes, for example Maximum observed plasma concentration, Time to attain maximum observed plasma concentration, Area under the plasma concentration-time curve from time 0 to infinity, Area under the concentration versus time curve from time zero to last measurable concentration, Terminal elimination half-life and Apparent clearance.

What This Means in Plain Language

Put simply, this is a phase 1, non-randomized trial of Petrelintide in 39 people.

Its size is small, so on its own it can only give an early look.

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.