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MBX 4291

Phase 1

Obesity | Small molecule | Metabolic |MBX Biosciences, Inc.|Last Updated: Jun 9, 2026

Target and mechanism

Molecular targetGLP-1/GIP
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment124

FDA Designations

No designations recorded

Clinical trial landscape

MBX 4291 · 1 trial · 1 indication

Phase 1 1
NCT07142707A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MBX 4291 in Adult Participants With ObesityObesity
RECRUITING124 Analytics
PHASE1RECRUITING
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MBX 4291 in Adult Participants With Obesity
ObesityUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of participants with Treatment Emergent Adverse Events (TEAEs)
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.
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
MBX 4291 (Part A)EXPERIMENTALParticipants will be administered single ascending doses of MBX 4291, or matching placebo.
MBX 4291 (Part B)EXPERIMENTALParticipants will be administered multiple ascending doses of MBX 4291, or matching placebo.
MBX 4291 (Part C)EXPERIMENTALParticipants will be administered multiple ascending doses of MBX 4291, or matching placebo.
PlaceboPLACEBO_COMPARATORParticipants will be administered single or multiple ascending doses of placebo.

Interventions

NameTypeDescription
MBX 4291DRUGMBX 4291 will be administered subcutaneously (SC)
PlaceboDRUGPlacebo: Placebo will be administered subcutaneously (SC)
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites4

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. Exclusi...

Countries:United States
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Recent Changes (Last 90 Days)

LOWJun 9, 2026NCT07142707lastUpdatePostDate: changed
LOWJun 9, 2026NCT07142707lastUpdatePostDate: changed

Frequently asked questions about MBX 4291

What is MBX 4291 used for?

MBX 4291 is an investigational small molecule being developed for the treatment of obesity. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and is still being studied for safety and effectiveness in clinical trials.

Who makes MBX 4291?

MBX 4291 is being developed by MBX Biosciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol MBX. The company is conducting clinical trials to evaluate the drug's safety, tolerability, pharmacokinetics, and pharmacodynamics in adult participants with obesity.

What phase is MBX 4291 in?

MBX 4291 is in Phase 1 clinical development. The drug is investigational and has not been approved by the FDA or any other regulatory agency. It is currently being studied in a Phase 1 trial to assess its safety, tolerability, and how the body processes the drug in adults with obesity.

What clinical trials is MBX 4291 in?

MBX 4291 is being evaluated in a Phase 1 clinical trial registered as NCT07142707. This study is recruiting 124 adult participants with obesity in the United States. The trial is randomized, double-blind, and placebo-controlled, and it is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of MBX 4291.

Is MBX 4291 FDA approved?

No, MBX 4291 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The drug is being studied in a clinical trial to evaluate its safety and tolerability in adults with obesity, but it has not yet received regulatory approval for any use.