RecruitingPhase 1

Pharmacokinetics of Petrelintide in Participants With Impaired Hepatic Function

Poland, Slovakia36 participantsStarted 2026-05-18

Plain-language summary

This clinical research trial is testing the investigational medicinal product (IMP) petrelintide that is being developed for body weight reduction in people living with obesity or overweight who have comorbidities. The aim of this clinical research trial is to investigate whether the pharmacokinetics (PK) of petrelintide will be different in people with hepatic impairment (HI) compared to people with normal hepatic function.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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..
. Clinical laboratory test results within normal reference range for the population, or results with acceptable deviations that are judged not to be clinically significant by the Investigator.
. Participants with stable HI for at least 3 months, classified as Child-Pugh Grade A, B, or C as assessed by the Investigator.
. Participants should be otherwise judged to be in acceptable health (type 2 diabetes mellitus \[T2DM\] is allowed) in the opinion of the Investigator based on a medical evaluation (including a physical examination, medical history, electrocardiogram \[ECG\], vital signs, concomitant medication and the results of laboratory safety tests) performed during the screening visit.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Day 1 (pre-dose) to Day 50 (Follow-up)

Trial details

NCT IDNCT07682818

SponsorZealand Pharma

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-04-12

Contact for this trial

Clinical Trial Information Desk

+4588773600 clinicaltrials@zealandpharma.com

View on ClinicalTrials.gov More Impaired Hepatic Function trials

Plain-language summary

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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..
. Clinical laboratory test results within normal reference range for the population, or results with acceptable deviations that are judged not to be clinically significant by the Investigator.
. Participants with stable HI for at least 3 months, classified as Child-Pugh Grade A, B, or C as assessed by the Investigator.
. Participants should be otherwise judged to be in acceptable health (type 2 diabetes mellitus \[T2DM\] is allowed) in the opinion of the Investigator based on a medical evaluation (including a physical examination, medical history, electrocardiogram \[ECG\], vital signs, concomitant medication and the results of laboratory safety tests) performed during the screening visit.

Pharmacokinetics of Petrelintide in Participants With Impaired Hepatic Function

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Contact for this trial

Pharmacokinetics of Petrelintide in Participants With Impaired Hepatic Function

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Contact for this trial

Exclusion criteria