NCT07142707

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MBX 4291 in Adult Participants With Obesity

A Randomized, Double-blind, Placebo-controlled First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of MBX 4291 in Adult Participants With Obesity

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: MBX Biosciences · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and tolerability of single and multiple subcutaneous (SC) doses of MBX 4291 in adults with obesity.

Detailed description

This is a Phase 1, double-blind, placebo-controlled first-in-human study to evaluate the single ascending doses (SAD) and multiple ascending doses (MAD) of MBX 4291 in participants with obesity, who are otherwise generally healthy. Approximately 64 patients aged 18 to 65 years old will be enrolled.

Conditions

• Obesity

Interventions

Type	Name	Description
DRUG	MBX 4291	MBX 4291 will be administered subcutaneously (SC)
DRUG	Placebo	Placebo: Placebo will be administered subcutaneously (SC)

Timeline

• Start date: 2025-09-03
• Primary completion: 2026-05-30
• Completion: 2026-05-30
• First posted: 2025-08-27
• Last updated: 2026-04-13

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study