Status:
RECRUITING
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MBX 4291 in Adult Participants With Obesity
Lead Sponsor:
MBX Biosciences
Conditions:
Obesity
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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 a...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 30 2026
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT07142707
Start Date
September 3 2025
End Date
May 30 2026
Last Update
December 15 2025
Active Locations (1)
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1
MBX Biosciences Investigational Site
Knoxville, Tennessee, United States, 37920