Petrelintide pharmacokinetics in people with different levels of liver function

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1, open-label, multicenter study to compare the pharmacokinetics, safety, and tolerability of a single subcutaneous dose of petrelintide in adults with normal hepatic function and in adults with hepatic impairment (mild, moderate, or severe, defined by Child-Pugh). Participants will be assigned to groups based on liver function and receive one SC dose on Day 1. Up to 18 participants with normal function and 18 with hepatic impairment (6 per impairment level) will be enrolled. The trial aims to see if liver function affects how the drug moves and is processed in the body, with safety monitoring throughout.

Why it matters

Who can join: the full rules

Inclusion Criteria:

All participants:

1. Sex: male and female participants.
2. Body mass index (BMI): 18.5 to 40.0 kg/m\^2, inclusive, at screening.

   Additional Inclusion Criteria for Participants with Normal Hepatic Function
3. Participants who are considered healthy as determined by medical history, physical examination, and other screening procedures, with clinically normal hepatic function at screening..
4. 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.

   Additional Inclusion Criteria for Participants with Hepatic Impairment
5. Participants with stable HI for at least 3 months, classified as Child-Pugh Grade A, B, or C as assessed by the Investigator.
6. 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.
7. Participants with T2DM may be enrolled if they have/are: a. Hemoglobin A1c ≤11% at screening b. On a stable regimen for at least 8 weeks prior to screening, defined as: stable diet and exercise program, and/or, stable dose of metformin, and/or, stable dose of a sodium-glucose cotransporter-2 inhibitor.

Exclusion Criteria:

All participants:

1. Known or suspected hypersensitivity to the IMP or related products.
2. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method.

Where it's running

• Centrum Badan Klinicznych Piotr Napora Lekarze sp.p.
  Wroclaw, Poland, Poland Recruiting
• Summit Clinical Research s.r.o.
  Bratislava, Bratislava Region, Slovakia Recruiting
• Summit Clinical Research s.r.o.
  Malacky, Malacky, Slovakia Recruiting

Study contacts

• Principal investigator: Clinical Trial Information Desk — Zealand Pharma A/S
• Study coordinator: Clinical Trial Information Desk
• Email: clinicaltrials@zealandpharma.com
• Phone: +4588773600

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.