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

Part of paid clinical trials in Doral, Florida.

Sponsor
MBX Biosciences
Study ID
NCT07142707
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • MBX 4291 — DRUG
    MBX 4291 will be administered subcutaneously (SC)
  • Placebo — DRUG
    Placebo: Placebo will be administered subcutaneously (SC)

Study Details

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.

Key Dates

Start date
Sep 3, 2025
Status verified
Jun 2026
Primary completion
Oct 30, 2026
Completion
Oct 30, 2026

Study Design

Enrollment
124 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: MBX 4291 (Part A)
    Participants will be administered single ascending doses of MBX 4291, or matching placebo.
  • Experimental: MBX 4291 (Part B)
    Participants will be administered multiple ascending doses of MBX 4291, or matching placebo.
  • Experimental: MBX 4291 (Part C)
    Participants will be administered multiple ascending doses of MBX 4291, or matching placebo.
  • Placebo Comparator: Placebo
    Participants will be administered single or multiple ascending doses of placebo.

Primary Outcome Measure

Number of participants with Treatment Emergent Adverse Events (TEAEs) [ Time Frame: 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. ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
MBX Biosciences Investigational SiteDoralFlorida33172-
MBX Biosciences Investigational SiteLexingtonKentucky40509-
MBX Biosciences Investigational SiteKansas CityMissouri64114-
MBX Biosciences Investigational SiteKnoxvilleTennessee37920-

Find similar trials in Doral, FL

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
MBX Biosciences Investigational Site· Doral, FLMBX Biosciences Investigational Site· Lexington, KYMBX Biosciences Investigational Site· Kansas City, MOMBX Biosciences Investigational Site· Knoxville, TN

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