A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MBX 4291 in Adult Participants With Obesity
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MBX 4291, Placebo.
- Who it may be relevant to
- Registry conditions: Obesity. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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 are otherwise generally healthy. Approximately 124 patients aged 18 to 65 years old will be enrolled.
Interventions
- Drug MBX 4291
MBX 4291 will be administered subcutaneously (SC) - Drug Placebo
Placebo: Placebo will be administered subcutaneously (SC)
Primary outcome measures
- Number of participants with Treatment Emergent Adverse Events (TEAEs) [Time frame: 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.]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 4 centers
- MBX Biosciences Investigational Site — Doral
- MBX Biosciences Investigational Site — Lexington
- MBX Biosciences Investigational Site — Kansas City
- MBX Biosciences Investigational Site — Knoxville
Identifiers
NCT: NCT07142707 · MBX-4O3001