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RecruitingPhase 1

Pharmacokinetics of Petrelintide in Participants With Impaired Hepatic Function

Pharmacokinetics of Petrelintide Following Administration to Participants With Impaired Hepatic Function

Lead sponsor

Zealand Pharma

Asset

Petrelintide

Subcutaneous · Amylin analog

Listed sites

3

Recruiting sites

3

Estimated enrollment

36

Study population

MASH / NAFLD / liver fibrosis

Eligibility highlights

BMI 18.5-40HbA1c ≤11%Healthy volunteers

Primary endpoint

AUC

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07682818
Org study IDZP8396-25077
Secondary ID2025-523641-10-00
Secondary IDUniversal Trial numberU1111-1328-8578

Timeline

Milestones

Study start2026-05-18actual
Study first posted2026-07-06actual
Last update posted2026-07-06actual
Primary completion2027-04-12estimated
Study completion2027-04-12estimated

Assets

Investigational agents

Who this study enrolls

MASH / NAFLD / liver fibrosis

Who can enroll

Minimum age18 Years
Maximum age70 Years
SexAll
Healthy volunteersAccepted

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.

Endpoints (8)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

8 endpoints
Primary/protocol endpoint

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)

concentration, descriptive

Secondary/protocol endpoint

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)

concentration, descriptive

Secondary/protocol endpoint

Maximum Observed Plasma Concentration (Cmax) of Petrelintide

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

concentration, descriptive

Secondary/protocol endpoint

Time to Cmax (tmax)

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

time to event, event

Secondary/protocol endpoint

Apparent Clearance (CL/F) of Petrelintide

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

concentration, descriptive

Secondary/protocol endpoint

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

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

concentration, descriptive

Secondary/protocol endpoint

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

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

descriptive

Secondary/protocol endpoint

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

Time frame:Day 1 up to Day 50

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 6, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.