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New obesity drug MBX 4291 enters first human safety trial

NCT ID NCT07142707

Disease control Sponsor: MBX Biosciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study is testing an experimental drug, MBX 4291, in 124 adults with obesity. The main goal is to check the drug's safety and how the body processes it. Participants will receive either the drug or a placebo as a shot under the skin, and researchers will monitor for side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
MBX 4291 (an experimental drug given as a shot under the skin)
What this could lead to
If safe and effective, this could lead to a new weight-loss medication for people with obesity.
What could go wrong
This is a very early Phase 1 trial focused on safety, not weight loss. The drug may not work or could have side effects. Many early-stage drugs never make it to market.
Why investors are watching

MBX Biosciences is a very small publicly traded company, and this Phase 1 trial is its first test of MBX 4291 in people. The study checks whether the drug is safe and tolerable in 124 adults with obesity, which is the first major hurdle for any new medicine. For a micro-cap company, this readout matters because it is the earliest evidence that its lead candidate might work in humans.

If it works: If the trial shows the drug is safe and well tolerated, MBX Biosciences could move the drug into larger studies. That result would give the company a clearer path forward and could attract more attention from partners or investors.

If it fails: Phase 1 trials often fail because the drug proves unsafe or causes side effects. If MBX 4291 fails or the trial is delayed, the company has few other products to fall back on, which could hurt its value and future plans.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 124 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Body Weight nutritional disorder Obesity obesity disorder Overweight

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Obesity

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • MBX Biosciences Investigational Site

    RECRUITING

    Doral, Florida, 33172, United States

  • MBX Biosciences Investigational Site

    RECRUITING

    Lexington, Kentucky, 40509, United States

  • MBX Biosciences Investigational Site

    RECRUITING

    Kansas City, Missouri, 64114, United States

  • MBX Biosciences Investigational Site

    RECRUITING

    Knoxville, Tennessee, 37920, United States

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