RecruitingPhase 1NCT07142707

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

Sponsor

MBX Biosciences

Enrollment

64 participants

Start Date

Sep 3, 2025

Study Type

INTERVENTIONAL

Conditions

Obesity

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria3

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 Criteria4

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.

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