Current partner codePEPTIDESDE
NCT07682818·Phase 1·INTERVENTIONAL

Pharmacokinetics of Petrelintide in Participants With Impaired Hepatic Function

Status

Recruiting

Phase

Phase 1

Enrollment

36

Locations

3

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Full 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.

Interventions

Treatment arms and agents.

DRUG

Petrelintide

Petrelintide will be administered as a single SC injection.

Timeline

From registration to results.

  1. First posted

    Jul 6, 2026

  2. Study start

    May 18, 2026

  3. Primary completion

    Apr 12, 2027

  4. Study completion

    Apr 12, 2027

  5. Results posted

    Not reported

  6. Registry updated

    Jul 6, 2026

Outcomes

What the study measures.

Primary outcomes

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

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)

Maximum Observed Plasma Concentration (Cmax) of Petrelintide

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

Time to Cmax (tmax)

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

Apparent Clearance (CL/F) of Petrelintide

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

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

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

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

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

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

Time frame · Day 1 up to Day 50

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
70 Years
Sex
ALL
Healthy volunteers
Yes

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 locations

3 registered sites.

Poland · Slovakia. Showing up to 24 locations stored in the fast local snapshot.

Centrum Badan Klinicznych Piotr Napora Lekarze sp.p.

Wroclaw, Poland, Poland

Summit Clinical Research s.r.o.

Bratislava, Bratislava Region, Slovakia

Summit Clinical Research s.r.o.

Malacky, Malacky, Slovakia

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Petrelintide.

Related PeptideStat pages

Put the record in context.

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