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

ConditionObesity
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMBX Biosciences

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • MBX 4291

    Drug

    MBX 4291 will be administered subcutaneously (SC)

  • Placebo

    Drug

    Placebo: Placebo will be administered subcutaneously (SC)

Treatment groups

124 Participants
are divided into 4 treatment groups
Group A: MBX 4291 (Part A)Experimental treatment 1 intervention
Group B: MBX 4291 (Part B)Experimental treatment 1 intervention
Group C: MBX 4291 (Part C)Experimental treatment 1 intervention
Group D: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Secondary outcomes

Other outcomes

Sponsors and contacts

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