Trial · Interventional
CompletedPhase 1Registry dataPharmacokinetics of Petrelintide Following Administration to Participants With Impaired Renal Function
Overview
- Status
- Completed
- Phase
- Phase 1
- Enrollment
- 39 participants (actual)
- Sponsor
- Zealand Pharma · Industry
- Design
- Not randomized · Double masking
- Countries
1 country
Germany
- Start
- 15 Apr 2025
- Primary completion
- 25 Nov 2025
- Completion
- 25 Nov 2025
- First posted
- 20 Jul 2025
- Last update posted
- 28 Jan 2026
- Conditions
- Renal Impairment
Timeline
1 trial · 1 completed
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 1
Pharmacokinetics of Petrelintide Following Administration to Participants With Impaired Renal Function
NCT0707603015 Apr 2025 to 25 Nov 2025
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This clinical research study is testing the study compound petrelintide that is being developed for the weight management in people with obesity or overweight with comorbidities or related diseases. The aim of this clinical research study is to investigate whether the effects of petrelintide will be different in people with normal kidney function compared to people with impaired kidney function.
Interventions
- PetrelintideDrug
Arms4
Experimental
Group 1 Normal Renal Function
Each participant will receive a single subcutaneous dose of petrelintide on Day 1.
Experimental
Group 2 Mild Renal Impairment
Each participant will receive a single subcutaneous dose of petrelintide on Day 1.
Experimental
Group 3 Moderate Renal Impairment
Each participant will receive a single subcutaneous dose of petrelintide on Day 1.
Experimental
Group 4 Severe Renal Impairment
Each participant will receive a single subcutaneous dose of petrelintide on Day 1.
Primary outcomes1
Outcomes the sponsor listed as primary.
AUCo-inf of petrelintide
Time frame · From administration (Day 1) to Last visit (Day 43)
Registry description
AUCo-inf: Area Under the Curve from time 0 to infinity
Secondary outcomes(7)
Maximum observed plasma concentration
Time frame · From administration (Day 1) to Last visit (Day 43)
Time to attain maximum observed plasma concentration
Time frame · From administration (Day 1) to Last visit (Day 43)
Area under the plasma concentration-time curve from time 0 to infinity
Time frame · From administration (Day 1) to Last visit (Day 43)
Area under the concentration versus time curve from time zero to last measurable concentration
Time frame · From administration (Day 1) to Last visit (Day 43)
Terminal elimination half-life
Time frame · From administration (Day 1) to Last visit (Day 43)
Apparent clearance
Time frame · From administration (Day 1) to Last visit (Day 43)
Apparent volume of distribution at terminal phase
Time frame · From administration (Day 1) to Last visit (Day 43)
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.
Completed trials do not always post results.
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 65 Years
- Healthy volunteers
- Accepted
Inclusion and exclusion criteria, as posted
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