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

Not Applicable

Recruiting

• Conditions: Obesity
• Interventions: Drug: MBX 4291; Drug: Placebo

• Registration Number: NCT07142707
• Lead Sponsor: MBX Biosciences

Brief 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.

Study Timeline

• Study First Submitted: 2025-08-04
• Study First Submitted QC: 2025-08-19
• Study First Posted: 2025-08-27
• Status Verified: 2025-09
• Study Start: 2025-09-03
• Last Update Submitted: 2025-09-05
• Last Update Posted: 2025-09-09
• Primary Completion: 2026-05-30
• Study Completion: 2026-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• Age of >18 to ≤65 years at the time of signing the informed consent.
• Has a BMI of ≥30 to <40 kg/m2 at screening and baseline.
• Weight-stable, i.e., no more than ±5% change in body weight for at least 3 months prior to screening and between screening and baseline.

Exclusion Criteria

• History of, or currently active, significant illness or medical disorders that in the opinion of the investigator may preclude participants from participating in the study.
• History of currently active pancreatitis, type I and type II diabetes.
• Secondary causes of obesity, including but not limited to hypothalamic, monogenic, syndromic, or endocrine causes.
• A personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MBX 4291 (Part A)	MBX 4291	Participants will be administered single ascending doses of MBX 4291, or matching placebo.
MBX 4291 (Part B)	MBX 4291	Participants will be administered multiple ascending doses of MBX 4291, or matching placebo.
Placebo	Placebo	Participants will be administered single or multiple ascending doses of placebo.

Primary Outcome Measures

Name	Time	Method
Number of participants with Treatment Emergent Adverse Events (TEAEs)	The total duration of study participation for each participant including screening, treatment period, follow-up, and end of study visit will be up to 91 days in Part A and up to 99 days in Part B.

Trial Locations

Locations (1)

MBX Biosciences Investigational Site; 🇺🇸 Knoxville, Tennessee, United States