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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Petrelintide will be administered as a single SC injection.
Centrum Badan Klinicznych Piotr Napora Lekarze sp.p.
Wroclaw, Poland, Poland
RECRUITINGSummit Clinical Research s.r.o.
Bratislava, Bratislava Region, Slovakia
RECRUITINGSummit Clinical Research s.r.o.
Malacky, Malacky, Slovakia
RECRUITINGArea 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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.