Investigating the Pharmacokinetics of Petrelintide Using Different Drug Product Concentrations
NCT07338214 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48
Last updated 2026-04-08
Summary
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.
Conditions
- Obesity & Overweight
Interventions
- DRUG
-
Solution administered with a syringe
Sponsors & Collaborators
-
ICON Clinical Research
collaborator INDUSTRY - lead INDUSTRY
Principal Investigators
-
Martha Haidacher · Charité Research Organisation GmbH
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 64 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-12-17
- Primary Completion
- 2026-03-31
- Completion
- 2026-03-31
Countries
- Germany
Study Locations
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