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New treatment option for Impaired Hepatic Function
Official title Pharmacokinetics of Petrelintide in Participants With Impaired Hepatic Function
ClinicalTrials.gov ID: NCT07682818
What this study is testing
What is Petrelintide?
Petrelintide is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for impaired hepatic function.
Also referred to as ZP8396.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70. Healthy volunteers may be eligible.
You may be able to join if
- All participants:
- Sex: male and female participants.
- Body mass index (BMI): 18.5 to 40.0 kg/m\^2, inclusive, at screening. Additional for Participants with Normal Hepatic Function
- Participants who are considered healthy as determined by medical history, physical examination, and other screening procedures, with clinically...
- Clinical laboratory test results within normal reference range for the population, or results with acceptable deviations that are judged not to be...
You likely can't join if
- All participants:
- 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...
See the full eligibility criteria
- All participants:
- Sex: male and female participants.
- Body mass index (BMI): 18.5 to 40.0 kg/m\^2, inclusive, at screening. Additional for Participants with Normal Hepatic Function
- 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. Additional for Participants...
- Participants with stable HI for at least 3 months, classified as Child-Pugh Grade A, B, or C as assessed by the Investigator.
- 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...
- 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...
- All participants:
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Wroclaw, Poland, Poland
- Bratislava, Bratislava Region, Slovakia
- Malacky, Malacky, Slovakia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wroclaw, Poland, Poland; Bratislava, Bratislava Region, Slovakia; Malacky, Malacky, Slovakia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.