NCT04348175

A Phase 1 Study to Evaluate the Pharmacokinetics of Setmelanotide in Subjects With Varying Degrees of Renal Impairment

A Phase 1, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of Setmelanotide in Subjects With Varying Degrees of Renal Impairment

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Rhythm Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 83 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 1, multi-center, open-label, single-dose study designed to assess the effect of renal impairment on the PK of setmelanotide. A total of approximately 32 subjects (approximately 8 subjects in each renal impairment group and 8 healthy subjects with normal renal function) are planned to be enrolled across 4 centers in the United States. At screening, subjects will be assigned to a study group according to eGFR. Cohort A - Mild Renal Impairment Cohort B - Moderate Renal Impairment Cohort C - Severe Renal Impairment Cohort D - Normal Renal Function (control)

Conditions

• Renal Insufficiency

Interventions

Type	Name	Description
DRUG	Setmelanotide	Setmelanotide will be administered as a single SC dose of 2.0 mg on Day 1. A dose higher than 2.0 mg will not be used during the study. Dose may be lowered based on safety data.

Timeline

• Start date: 2020-07-09
• Primary completion: 2021-04-17
• Completion: 2021-04-17
• First posted: 2020-04-16
• Last updated: 2021-06-30

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study