Pharmacokinetics of Petrelintide in Participants With Impaired Hepatic Function

NCT07682818 | Recruiting Phase 1 DMC

• 3 other identifiers: ZP8396-250772025-523641-10-00Universal Trial number
• Study Type: interventional
• Target: 36
• Locations: 2 countries
• Sites: 3

Brief 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.

Conditions

Impaired Hepatic Function

Keywords

HI; Impaired Hepatic Function; Petrelintide

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (7)

• AUC from Time Zero up to Time of Last Measurable Concentration (AUC0-last) of Petrelintide

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

• Maximum Observed Plasma Concentration (Cmax) of Petrelintide

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

• Time to Cmax (tmax)

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

• Apparent Clearance (CL/F) of Petrelintide

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

• Terminal Elimination Half-life (t1/2) of Petrelintide

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

Study Arms (4)

Petrelintide: Normal Hepatic Function

EXPERIMENTAL

Participants with normal hepatic function will receive a single SC dose of petrelintide.

Drug: Petrelintide

Petrelintide: Mild HI

EXPERIMENTAL

Participants with mild HI will receive a single SC dose of petrelintide.

Drug: Petrelintide

Petrelintide: Moderate HI

EXPERIMENTAL

Participants with moderate HI will receive a single SC dose of petrelintide.

Drug: Petrelintide

Petrelintide: Severe HI

EXPERIMENTAL

Participants with severe HI will receive a single SC dose of petrelintide.

Drug: Petrelintide

Interventions

Petrelintide DRUG

Petrelintide will be administered as a single SC injection.

Also known as: ZP8396

Petrelintide: Mild HI; Petrelintide: Moderate HI; Petrelintide: Normal Hepatic Function; Petrelintide: Severe HI

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All participants:
• 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.
• 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.

You may not qualify if:

• All participants:
• Known or suspected hypersensitivity to the IMP or related products.
• 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.

Sponsors & Collaborators

• Zealand Pharma: lead

Study Sites (3)

Centrum Badan Klinicznych Piotr Napora Lekarze sp.p.

Wroclaw, Poland, 51-162, Poland

RECRUITING

Summit Clinical Research s.r.o.

Bratislava, Bratislava Region, 831 01, Slovakia

RECRUITING

Summit Clinical Research s.r.o.

Malacky, Malacky, 901 01, Slovakia

RECRUITING

Study Officials

• Clinical Trial Information Desk

  Zealand Pharma A/S

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trial Information Desk

CONTACT

+4588773600; clinicaltrials@zealandpharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2026
• First Posted: July 6, 2026
• Study Start: May 18, 2026
• Primary Completion (Estimated): April 12, 2027
• Study Completion (Estimated): April 12, 2027
• Last Updated: July 6, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

SL (2); PL (1)