Pharmacokinetics of Petrelintide in Participants With Impaired Hepatic Function

What Was Tested

The trial (phase 1) is built around Petrelintide.

It had four arms (groups): Petrelintide: Normal Hepatic Function (experimental), Petrelintide: Mild HI (experimental), Petrelintide: Moderate HI (experimental) and Petrelintide: Severe HI (experimental).

The registry classes the interventions as drug.

More on the Plan

Allocation of participants to the hepatic function groups will be based on Child-Pugh classification.

Up to 18 participants with normal hepatic function and 18 participants with HI (6 participants each in the following groups: mild, moderate, or severe HI) will participate in this trial.

Who Took Part

Enrollment: 36 planned participants were the target.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Sex: male and female participants. Body mass index (BMI): 18.5 to 40.0 kg/m\^2, inclusive, at screening. Participants who are considered healthy as determined by medical history, physical examination, and other screening procedures, with clinically normal hepatic function at screening.. Participants with stable HI for at least 3 months, classified as Child-Pugh Grade A, B, or C as assessed by the Investigator.

The full record lists 7 inclusion and 2 exclusion criteria; among the exclusions: known or suspected hypersensitivity to the imp or related products.

How the Study Was Run

Design: non-randomized, parallel-group and open-label.

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

Everyone knew when Petrelintide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2026-05-18 with completion listed for 2027-04-12.

It ran at 3 sites in Slovakia (2) and Poland (1).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Area Under the Plasma Concentration-time Curve (AUC) from Time Zero to Infinity (AUC0-inf) of Petrelintide.

It also tracked 7 secondary outcomes, for example AUC from Time Zero up to Time of Last Measurable Concentration (AUC0-last) of Petrelintide, Maximum Observed Plasma Concentration (Cmax) of Petrelintide, Time to Cmax (tmax), Apparent Clearance (CL/F) of Petrelintide, Terminal Elimination Half-life (t1/2) of Petrelintide and Apparent Volume of Distribution at Terminal Phase (Vz/F) of Petrelintide.

What This Means in Plain Language

Put simply, this is a phase 1, non-randomized trial of Petrelintide in 36 people.

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

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.