Pharmacokinetics of Petrelintide in Participants With Impaired Hepatic Function

Pharmacokinetics of Petrelintide Following Administration to Participants With Impaired Hepatic Function

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.

Study Overview

• Status: Recruiting
• Conditions: Impaired Hepatic Function
• Intervention / Treatment: Drug: Petrelintide

Detailed Description

This is a Phase 1, open-label, multicenter, single-dose, parallel-group, non-randomized trial to evaluate the PK, safety, and tolerability of petrelintide after a single dose in participants with mild, moderate, or severe HI, and participants with normal hepatic function. Allocation of participants to the hepatic function groups will be based on Child-Pugh classification.

Each participant will receive a single subcutaneous (SC) dose of petrelintide on Day 1.

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.

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Clinical Trial Information Desk; Phone Number: +4588773600; Email: clinicaltrials@zealandpharma.com

Study Locations

• Poland
  • Poland
    • Wroclaw, Poland, Poland, 51-162
      • Recruiting
      • Centrum Badan Klinicznych Piotr Napora Lekarze sp.p.
      • Contact: Piotr Napora, Dr.; Phone Number: +483267900; Email: napora.piotr@cbk.wroc.pl
• Slovakia
  • Bratislava Region
    • Bratislava, Bratislava Region, Slovakia, 831 01
      • Recruiting
      • Summit Clinical Research s.r.o.
      • Contact: Viera Kupčová, Dr.; Phone Number: +421905286213; Email: viera.kupcova@summit-cr.eu
  • Malacky
    • Malacky, Malacky, Slovakia, 901 01
      • Recruiting
      • Summit Clinical Research s.r.o.
      • Contact: Edita Kadlubiaková, Dr.; Phone Number: +421905434699; Email: edita.kadlubiakova@summit-cr.eu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Petrelintide: Normal Hepatic Function; Participants with normal hepatic function will receive a single SC dose of petrelintide.	Drug: Petrelintide; Petrelintide will be administered as a single SC injection.; Other Names: ZP8396
Experimental: Petrelintide: Mild HI; Participants with mild HI will receive a single SC dose of petrelintide.	Drug: Petrelintide; Petrelintide will be administered as a single SC injection.; Other Names: ZP8396
Experimental: Petrelintide: Moderate HI; Participants with moderate HI will receive a single SC dose of petrelintide.	Drug: Petrelintide; Petrelintide will be administered as a single SC injection.; Other Names: ZP8396
Experimental: Petrelintide: Severe HI; Participants with severe HI will receive a single SC dose of petrelintide.	Drug: Petrelintide; Petrelintide will be administered as a single SC injection.; Other Names: ZP8396

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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)
Apparent Volume of Distribution at Terminal Phase (Vz/F) of Petrelintide	Day 1 (pre-dose) to Day 50 (Follow-up)
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)	Day 1 up to Day 50

Collaborators and Investigators

• Sponsor: Zealand Pharma
• Investigators: Principal Investigator: Clinical Trial Information Desk, Zealand Pharma A/S

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2026
• Primary Completion (Estimated): April 12, 2027
• Study Completion (Estimated): April 12, 2027

Study Registration Dates

• First Submitted: June 26, 2026
• First Submitted That Met QC Criteria: June 26, 2026
• First Posted (Actual): July 6, 2026

Study Record Updates

• Last Update Posted (Actual): July 6, 2026
• Last Update Submitted That Met QC Criteria: June 26, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: HI; Impaired Hepatic Function; Petrelintide
• Other Study ID Numbers: ZP8396-25077; Universal Trial number (Other Identifier: U1111-1328-8578); 2025-523641-10-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No