DRUG
Petrelintide
Petrelintide will be administered as a single SC injection.
Status
Recruiting
Phase
Phase 1
Enrollment
36
Locations
3
Results
Not posted
Publications
0
Study summary
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.
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
DRUG
Petrelintide will be administered as a single SC injection.
Timeline
First posted
Jul 6, 2026
Study start
May 18, 2026
Primary completion
Apr 12, 2027
Study completion
Apr 12, 2027
Results posted
Not reported
Registry updated
Jul 6, 2026
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)
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
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
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
No PMID-linked publications were present in this registry snapshot.
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