Pharmacokinetics of Petrelintide in Participants With Impaired Hepatic Function
ConditionImpaired Hepatic Function
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorZealand Pharma
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Sex: male and female participants.
Body mass index (BMI): 18.5 to 40.0 kg/m², inclusive, at screening.
Participants who are considered healthy as determined by medical history, physical examination, and other screening procedures, with clinically normal hepatic function at screening..
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.
Disqualifiers
Known or suspected hypersensitivity to the IMP or related products.
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Petrelintide
DrugPetrelintide will be administered as a single SC injection.
Treatment groups
36 Participants
are divided into 4 treatment groupsGroup A: Petrelintide: Normal Hepatic FunctionExperimental treatment 1 intervention
Group B: Petrelintide: Mild HIExperimental treatment 1 intervention
Group C: Petrelintide: Moderate HIExperimental treatment 1 intervention
Group D: Petrelintide: Severe HIExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
1
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)2
Maximum Observed Plasma Concentration (Cmax) of Petrelintide
Time frame
Day 1 (pre-dose) to Day 50 (Follow-up)3
Time to Cmax (tmax)
Time frame
Day 1 (pre-dose) to Day 50 (Follow-up)4
Apparent Clearance (CL/F) of Petrelintide
Time frame
Day 1 (pre-dose) to Day 50 (Follow-up)Sponsors and contacts
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Source ClinicalTrials.gov