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

Phase 1

Recruiting

• Conditions: Renal Impairment
• Interventions: Drug: MBX 2109

• Registration Number: NCT06496217
• Lead Sponsor: MBX Biosciences

Brief 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

Study Timeline

• Study Start: 2024-05-24
• Study First Submitted: 2024-06-12
• Status Verified: 2024-07
• Study First Submitted QC: 2024-07-03
• Study First Posted: 2024-07-11
• Last Update Submitted: 2024-07-17
• Last Update Posted: 2024-07-18
• Primary Completion: 2024-10-12
• Study Completion: 2024-10-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Single 900 µg dose of MBX 2109	MBX 2109	A single, 900 µg dose of MBX 2109 will be administered subcutaneously in the abdomen

Primary Outcome Measures

Name	Time	Method
Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC0-∞)	Baseline through Day 36	Assess the plasma pharmacokinetics (PK) of MBX 2109 and MBX 2099 following a single 900 µg subcutaneous (SC) dose
Maximum observed concentration (Cmax)	Baseline through Day 36	Assess the plasma pharmacokinetics (PK) of MBX 2109 and MBX 2099 following a single 900 µg subcutaneous (SC) dose
Area under the plasma concentration-time curve from time 0 to time of last quantifiable sample (AUC0-T)	Baseline through Day 36	Assess the plasma pharmacokinetics (PK) of MBX 2109 and MBX 2099 following a single 900 µg subcutaneous (SC) dose
Apparent clearance (CL/F) (MBX 2109 only)	Baseline through Day 36	Assess the plasma pharmacokinetics (PK) of MBX 2109 and MBX 2099 following a single 900 µg subcutaneous (SC) dose
Time to maximum concentration (Tmax)	Baseline through Day 36	Assess the plasma pharmacokinetics (PK) of MBX 2109 and MBX 2099 following a single 900 µg subcutaneous (SC) dose
Terminal elimination half-life (t1/2)	Baseline through Day 36	Assess the plasma pharmacokinetics (PK) of MBX 2109 and MBX 2099 following a single 900 µg subcutaneous (SC) dose
Apparent volume of distribution (Vz/F) (MBX 2109 only)	Baseline through Day 36	Assess the plasma pharmacokinetics (PK) of MBX 2109 and MBX 2099 following a single 900 µg subcutaneous (SC) dose

Trial Locations

Locations (2)

MBX Biosciences Investigational Site; 🇺🇸 Minneapolis, Minnesota, United States

MBX Bioscience Investigational Site; 🇺🇸 Tampa, Florida, United States