Testing MBX 4291 for safety and body effects in adults with obesity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a first-in-human, double-blind, placebo-controlled Phase 1 study using single ascending dose (SAD) and multiple ascending dose (MAD) designs to characterize safety, tolerability, pharmacokinetics, and pharmacodynamics of MBX 4291. About 124 adults aged 18–65 with BMI 30 to <50 kg/m2 who are otherwise generally healthy will be enrolled. Participants will receive subcutaneous doses of MBX 4291 or placebo and undergo scheduled safety and laboratory monitoring as well as PK/PD sampling. The study excludes people with diabetes, active pancreatitis, secondary causes of obesity, and certain thyroid cancer risk factors.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age of \>18 to ≤65 years at the time of signing the informed consent.
* Has a BMI of ≥30 to \<50 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.

Where it's running

• MBX Biosciences Investigational Site
  Doral, Florida, United States Recruiting
• MBX Biosciences Investigational Site
  Lexington, Kentucky, United States Recruiting
• MBX Biosciences Investigational Site
  Kansas City, Missouri, United States Recruiting
• MBX Biosciences Investigational Site
  Knoxville, Tennessee, United States Recruiting

Study contacts

• Study coordinator: Elisa Fabbrini, MD, PhD
• Email: MBX4291.Clinicaltrials@mbxbio.com
• Phone: 844-877-4473

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.