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MBX 4291

Phase 1

Obesity | Small molecule | Metabolic |MBX Biosciences, Inc.|Last Updated: Jun 2, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment124
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07142707A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MBX 4291 in Adult Participants With ObesityPHASE1 RECRUITING 124Sep 3, 2025Oct 30, 2026Jun 2, 20264 United States
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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 — 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 2, 2026NCT07142707lastUpdatePostDate: changed
LOWJun 2, 2026NCT07142707lastUpdatePostDate: changed
LOWJun 2, 2026NCT07142707lastUpdatePostDate: changed
MEDIUMMay 26, 2026NCT07142707Enrollment: 64 → 124
LOWMay 24, 2026NCT07142707studyFirstPostDate: changed