Trial · Interventional
RecruitingPhase 1Registry dataPharmacokinetics of Petrelintide in Participants With Impaired Hepatic Function
Overview
- Status
- Recruiting
- Phase
- Phase 1
- Enrollment
- 36 participants (estimated)
- Sponsor
- Zealand Pharma · Industry
- Design
- Not randomized · Open label (no masking)
- Countries
2 countries
Poland, Slovakia
- Start
- 18 May 2026
- Primary completion
- 12 Apr 2027 (estimated)
- Completion
- 12 Apr 2027 (estimated)
- First posted
- 6 Jul 2026
- Last update posted
- 6 Jul 2026
- Conditions
- Impaired Hepatic Function
Timeline
1 trial · 1 ongoing
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 1
Pharmacokinetics of Petrelintide in Participants With Impaired Hepatic Function
NCT0768281818 May 2026 to est. 12 Apr 2027
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- PetrelintideDrug
Arms4
Experimental
Petrelintide: Normal Hepatic Function
Participants with normal hepatic function will receive a single SC dose of petrelintide.
Experimental
Petrelintide: Mild HI
Participants with mild HI will receive a single SC dose of petrelintide.
Experimental
Petrelintide: Moderate HI
Participants with moderate HI will receive a single SC dose of petrelintide.
Experimental
Petrelintide: Severe HI
Participants with severe HI will receive a single SC dose of petrelintide.
Primary outcomes1
Outcomes the sponsor listed as primary.
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(7)
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
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
A trial that is still running, or that stopped early, may post results later.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 70 Years
- Healthy volunteers
- Accepted
Inclusion and exclusion criteria, as posted
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