RECRUITINGPhase 1INTERVENTIONAL
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
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- Age of \>18 to ≤65 years at the time of signing the willing to sign a consent form.
- 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.
Who Should NOT Join This Trial:
- 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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* 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 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 Being Tested
DRUG
MBX 4291
MBX 4291 will be administered subcutaneously (SC)
DRUG
Placebo
Placebo: Placebo will be administered subcutaneously (SC)
Locations (1)
MBX Biosciences Investigational Site
Knoxville, Tennessee, United States