NCT06496217

Safety and Pharmacokinetics Study of MBX 2109 in Adult Subjects With Normal and Impaired Renal Function

A Phase 1, Open-Label, Parallel-Group, Single Dose Adaptive Study to Evaluate the Safety and Pharmacokinetics of MBX 2109 in Adult Subjects With Normal and Impaired Renal Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: MBX Biosciences · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

Evaluate the Safety and Pharmacokinetics of MBX 2109 in Adult Subjects with Normal and Impaired Renal Function

Detailed description

A Phase 1, Open-Label, Parallel-Group, Single-Dose Adaptive Study to Evaluate the Safety and Pharmacokinetics of MBX 2109 in Adult Subjects with Normal and Impaired Renal Function

Conditions

• Renal Impairment

Interventions

Type	Name	Description
DRUG	MBX 2109	Group 1: Subjects with mild renal impairment (eGFR ≥ 60 and \< 90 mL/min)
DRUG	MBX 2109	Group 2: Subjects with moderate renal impairment (eGFR ≥ 30 and \< 60 mL/min)
DRUG	MBX 2109	Group 3: Subjects with severe renal impairment (eGFR \< 30 mL/min), or kidney failure and not receiving dialysis
DRUG	MBX 2109	Group 4: Matched healthy subjects with normal renal function (eGFR ≥ 90 mL/min)

Timeline

• Start date: 2024-06-13
• Primary completion: 2025-09-04
• Completion: 2025-09-04
• First posted: 2024-07-11
• Last updated: 2025-10-28

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study