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Recruiting Phase 1

Pharmacokinetics of Petrelintide in Participants With Impaired Hepatic Function

NCT07682818 · tracked via the Priya Life Science Poland tracker
Phase
Phase 1
Started
2026-05-18
Last updated
2026-07-06

Condition(s) studied

Impaired Hepatic Function

Investigational drug(s) / intervention(s)

Petrelintide

Petrelintide: Petrelintide will be administered as a single SC injection.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • Area Under the Plasma Concentration-time Curve (AUC) from Time Zero to Infinity (AUC0-inf) of Petrelintide — Day 1 (pre-dose) to Day 50 (Follow-up)

Trial sites (3)

FacilityCityRegionStatus
Centrum Badan Klinicznych Piotr Napora Lekarze sp.p. Wroclaw Poland Recruiting
Summit Clinical Research s.r.o. Bratislava Bratislava Region Recruiting
Summit Clinical Research s.r.o. Malacky Malacky Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07682818 on ClinicalTrials.gov ↗ ← All trials in Poland