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RecruitingPhase 1

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety of MBX 4291 and how well adults with obesity can handle it. It gives one or more doses as shots under the skin.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Older than 18 and no older than 65 when signing the consent form.
  • Have a BMI of at least 30 but less than 50 at screening and the start of the study. BMI is a measure of weight compared with height.
  • Weight has not gone up or down by more than 5% for at least 3 months before screening and until the start of the study.

Who can't join

  • Have or have had a serious illness or medical condition that the study doctor thinks would prevent you from taking part.
  • Have or have had pancreatitis (swelling of the pancreas), type 1 diabetes, or type 2 diabetes.
  • Have obesity caused by another condition, such as a problem with hormones, genes, or the part of the brain that controls hunger.
  • You or a family member have had medullary thyroid cancer (a type of thyroid cancer) or multiple endocrine neoplasia type 2 (a condition that causes tumors in glands that make hormones).

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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.

Study sites (4)

FL

KY

MO

TN