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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-03

Study Completion Date

2026-05-30

Brief Summary

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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.

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Detailed Description

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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 64 patients aged 18 to 65 years old will be enrolled.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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MBX 4291 (Part A)

Participants will be administered single ascending doses of MBX 4291, or matching placebo.

Group Type EXPERIMENTAL

MBX 4291

Intervention Type DRUG

MBX 4291 will be administered subcutaneously (SC)

MBX 4291 (Part B)

Participants will be administered multiple ascending doses of MBX 4291, or matching placebo.

Group Type EXPERIMENTAL

MBX 4291

Intervention Type DRUG

MBX 4291 will be administered subcutaneously (SC)

Placebo

Participants will be administered single or multiple ascending doses of placebo.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo: Placebo will be administered subcutaneously (SC)

Interventions

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MBX 4291

MBX 4291 will be administered subcutaneously (SC)

Intervention Type DRUG

Placebo

Placebo: Placebo will be administered subcutaneously (SC)

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No