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

MBX Biosciences

Status and phase: Enrolling; Phase 1

Conditions: Obesity

Treatments: Drug: MBX 4291; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07142707

MBX-4O3001

Details and patient eligibility

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.

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

Enrollment: 64 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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64 participants in 3 patient groups, including a placebo group

MBX 4291 (Part A)

Experimental group

Description:

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

Treatment:

Drug: MBX 4291

MBX 4291 (Part B)

Experimental group

Description:

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

Treatment:

Drug: MBX 4291

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo