Skip to content

Trial · Interventional

RecruitingPhase 1Registry data

Pharmacokinetics of Petrelintide in Participants With Impaired Hepatic Function

NCTNCT07682818 (opens ClinicalTrials.gov in a new tab)Other idZP8396-25077Other id2025-523641-10-00Other idUniversal Trial numberOther id2025

Overview

Status
Recruiting
Phase
Phase 1
Enrollment
36 participants (estimated)
Sponsor
Zealand Pharma · Industry
Design
Not randomized · Open label (no masking)
Countries
2 countries

Poland, Slovakia

Start
18 May 2026
Primary completion
12 Apr 2027 (estimated)
Completion
12 Apr 2027 (estimated)
First posted
6 Jul 2026
Last update posted
6 Jul 2026
Conditions
Impaired Hepatic Function

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202620272028
  1. Ph 1

    Pharmacokinetics of Petrelintide in Participants With Impaired Hepatic Function

    NCT07682818

    18 May 2026 to est. 12 Apr 2027

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • PetrelintideDrug

Arms4

  • Experimental

    Petrelintide: Normal Hepatic Function

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

  • Experimental

    Petrelintide: Mild HI

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

  • Experimental

    Petrelintide: Moderate HI

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

  • Experimental

    Petrelintide: Severe HI

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

Primary outcomes1

Outcomes the sponsor listed as primary.

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

    Time frame · Day 1 (pre-dose) to Day 50 (Follow-up)

Secondary outcomes(7)
  1. AUC from Time Zero up to Time of Last Measurable Concentration (AUC0-last) of Petrelintide

    Time frame · Day 1 (pre-dose) to Day 50 (Follow-up)

  2. Maximum Observed Plasma Concentration (Cmax) of Petrelintide

    Time frame · Day 1 (pre-dose) to Day 50 (Follow-up)

  3. Time to Cmax (tmax)

    Time frame · Day 1 (pre-dose) to Day 50 (Follow-up)

  4. Apparent Clearance (CL/F) of Petrelintide

    Time frame · Day 1 (pre-dose) to Day 50 (Follow-up)

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

    Time frame · Day 1 (pre-dose) to Day 50 (Follow-up)

  6. Apparent Volume of Distribution at Terminal Phase (Vz/F) of Petrelintide

    Time frame · Day 1 (pre-dose) to Day 50 (Follow-up)

  7. Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)

    Time frame · Day 1 up to Day 50

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 70 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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.

PepBank is a research reference. Talk to a doctor before you use any peptide.