drugset / Trial / NCT07338214

Investigating the Pharmacokinetics of Petrelintide Using Different Drug Product Concentrations

NCT07338214 ↗

Phase 1 Completed 48 enrolled Zealand Pharma ICON Clinical Research · collab
RandomizedParallel-groupOpen-labelBasic science

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.

Timeline

Start
2025-12-17
Primary completion
2026-03-31
Completion
2026-03-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Petrelintide Protein / enzyme biologic — Subcutaneous

Indications