Trial · Interventional
CompletedPhase 1Registry dataInvestigating the Pharmacokinetics of Petrelintide Using Different Drug Product Concentrations
Overview
- Status
- Completed
- Phase
- Phase 1
- Enrollment
- 48 participants (actual)
- Sponsor
- Zealand Pharma · Industry
- Design
- Randomized · Open label (no masking)
- Countries
1 country
Germany
- Start
- 17 Dec 2025
- Primary completion
- 31 Mar 2026
- Completion
- 31 Mar 2026
- First posted
- 13 Jan 2026
- Last update posted
- 8 Apr 2026
- Conditions
- Obesity & Overweight
Timeline
1 trial · 1 completed
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 1
Investigating the Pharmacokinetics of Petrelintide Using Different Drug Product Concentrations
NCT0733821417 Dec 2025 to 31 Mar 2026
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 co-morbidities or related diseases. The goal is to learn how the same single dose of petrelintide, given using different concentrations, works in the body when given to participants with a BMI at, or above, 27kg/m2. The main questions it aims to answer are: 1. Are there differences in how the body absorbs, distributes, metabolises and excretes petrelintide when same single dose petrelintide is given using different concentrations? 2. Are there differences in safety of petrelintide when same single dose petrelintide is given using different concentrations? Participants will: Visit the study center 10 times for tests and blood sampling (9 day ambulatory visits and 1 in-house visit of 4 consecutive days with sleeping 3 nights at the study center). Petrelintide will be given once as a single injection in a skin fold of the abdomen on Day 1. The participants will be monitored until approximately Day 50.
Interventions
- PetrelintideDrug
Arms4
Active comparator
Arm A
Each participant will receive a single subcutaneous dose of petrelintide strength A on Day 1.
Active comparator
Arm B
Each participant will receive a single subcutaneous dose of petrelintide strength B on Day 1.
Active comparator
Arm C
Each participant will receive a single subcutaneous dose of petrelintide strength C on Day 1.
Active comparator
Arm D
Each participant will receive a single subcutaneous dose of petrelintide strength D on Day 1.
Primary outcomes2
Outcomes the sponsor listed as primary.
To investigate the Pharmacokinetics of a single dose administration of petrelintide administered subcutaneously using 4 different drug product concentrations in participants with overweight or obesity
Time frame · Day 1 - day 50 (+/- 2)
Registry description
Area under the petrelintide plasma concentration time curve from time zero to infinity after a single dose of petrelintide (AUC0-inf)
To investigate the Pharmacokinetics of a single dose administration of petrelintide administered subcutaneously using 4 different drug product concentrations in participants with overweight or obesity
Time frame · Day 1 - day 50 (+/- 2)
Registry description
Maximum observed plasma concentration (Cmax) from time zero to infinity after a single dose of petrelintide
Secondary outcomes(5)
To investigate the Pharmacokinetics of a single dose administration of petrelintide administered subcutaneously using 4 different drug product concentrations in participants with overweight or obesity
Time frame · Day 1 - day 50 (+/- 2)
Registry description
Area under the petrelintide plasma concentration time curve from time zero to last measurable concentration after a single dose of petrelintide (AUC0-t)
To investigate the Pharmacokinetics of a single dose administration of petrelintide administered subcutaneously using 4 different drug product concentrations in participants with overweight or obesity
Time frame · Day 1 - day 50 (+/- 2)
Registry description
Time to maximum observed petrelintide plasma concentration after a single dose of petrelintide (Tmax)
To investigate the Pharmacokinetics of a single dose administration of petrelintide administered subcutaneously using 4 different drug product concentrations in participants with overweight or obesity
Time frame · Day 1 - day 50 (+/- 2)
Registry description
Terminal elimination half-life for petrelintide after a single dose of petrelintide (t1/2)
To investigate the Pharmacokinetics of a single dose administration of petrelintide administered subcutaneously using 4 different drug product concentrations in participants with overweight or obesity
Time frame · Day 1 - day 50 (+/- 2)
Registry description
Apparent clearance of petrelintide after a single dose of petrelintide (CL/F)
To investigate the safety and tolerability of a single dose administration of petrelintide administered subcutaneously using 4 different drug product concentrations in participants with overweight or obesity
Time frame · Day 1 - day 50 (+/- 2)
Registry description
Incidence of treatment-emergent adverse events (TEAEs) from dosing (Day 1) to end of follow-up
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 64 Years
- Healthy volunteers
- Accepted
Inclusion and exclusion criteria, as posted
PepBank is a research reference. Talk to a doctor before you use any peptide.