NCT07076030

Pharmacokinetics of Petrelintide Following Administration to Participants With Impaired Renal Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Zealand Pharma · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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 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.

Detailed description

This is a Phase 1, open-label, single-center, single dose, parallel-group, non-randomized study to evaluate the pharmacokinetics (PK), safety, and tolerability of petrelintide after a single dose in participants with mild, moderate, or severe renal impairment, and participants with normal renal function. Allocation of participants to the renal function groups will be based on the estimated glomerular filtration rate (eGFR). Each participant will receive a single subcutaneous dose of petrelintide on Day 1. Up to 24 participants with normal renal function and 24 participants with renal impairment (8 participants each in the following groups: mild, moderate, or severe renal impairment) will participate in this study.

Conditions

• Renal Impairment

Interventions

Type	Name	Description
DRUG	Petrelintide	Solution administered with a syringe

Timeline

• Start date: 2025-04-15
• Primary completion: 2025-11-25
• Completion: 2025-11-25
• First posted: 2025-07-20
• Last updated: 2026-01-28

Locations

1 site across 1 country: Germany

Regulatory

• FDA-regulated drug study