Clinical trial

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

Recruiting now · Phase 1 · 1 countries · Registry ID NCT07142707

Recruiting nowPhase 1Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years
SexAll
Healthy volunteersNot accepted
ConditionObesity

Full registry criteria

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.

Treatments and study arms

MBX 4291

Drug

MBX 4291 will be administered subcutaneously (SC)

Placebo

Drug

Placebo: Placebo will be administered subcutaneously (SC)

Primary outcomes

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, up to 99 days in Part B, and up to 148 days in Part C.

Study locations

4 locations were listed when this page was built. The first 40 are shown.

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