Pharmacokinetics of Petrelintide in Participants With Impaired Hepatic Function
Pharmacokinetics of Petrelintide Following Administration to Participants With Impaired Hepatic Function
Lead sponsor
Asset
Petrelintide
Subcutaneous · Amylin analog
Listed sites
3
Recruiting sites
3
Estimated enrollment
36
Study population
MASH / NAFLD / liver fibrosis
Eligibility highlights
•BMI 18.5-40•HbA1c ≤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
Timeline
Milestones
Assets
Investigational agents
Who this study enrolls
Who can enroll
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 endpointsArea 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
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
Maximum Observed Plasma Concentration (Cmax) of Petrelintide
Time frame:Day 1 (pre-dose) to Day 50 (Follow-up)
concentration, descriptive
Time to Cmax (tmax)
Time frame:Day 1 (pre-dose) to Day 50 (Follow-up)
time to event, event
Apparent Clearance (CL/F) of Petrelintide
Time frame:Day 1 (pre-dose) to Day 50 (Follow-up)
concentration, descriptive
Terminal Elimination Half-life (t1/2) of Petrelintide
Time frame:Day 1 (pre-dose) to Day 50 (Follow-up)
concentration, descriptive
Apparent Volume of Distribution at Terminal Phase (Vz/F) of Petrelintide
Time frame:Day 1 (pre-dose) to Day 50 (Follow-up)
descriptive
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Time frame:Day 1 up to Day 50
event count, event
Provenance
Sources
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.