RECRUITING

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

Conditions

Obesity Body Weight Body Mass Index Overweight Nutrition Disorders

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2025-08-26

Study Completion:2026-05-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07142707

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Elisa Fabbrini, MD, PhD

CONTACT

844-877-4473

MBX4291.Clinicaltrials@mbxbio.com

Stewart Hallett

CONTACT

844-877-4473

MBX4291.Clinicaltrials@mbxbio.com

Study Locations (Sites)

MBX Biosciences Investigational Site

Knoxville, Tennessee, 37920

United States

Collaborators and Investigators

Sponsor: MBX Biosciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-26

Study Completion Date2026-05-30

Study Record Updates

Study Start Date2025-08-26

Study Completion Date2026-05-30

Terms related to this study

Keywords Provided by Researchers

Body Weight
Body Mass Index
Overweight
Nutrition Disorders

Additional Relevant MeSH Terms

Obesity