Study to Evaluate Efficacy and Dose Response of Imapextide (STEADI)

Conditions

• Postbariatric Hypoglycemia

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• MBX 1416 (INN imapextide) — DRUG
  A single subcutaneous injection of MBX 1416 at a low dose and a high dose approximately 2 weeks apart.

Study Details

The purpose of this study is to assess the preliminary efficacy of single SC administration of MBX 1416 at different dose levels in patients with PBH

Key Dates

Start date

Aug 26, 2025

Status verified

Dec 2025

Primary completion

Dec 22, 2025

Completion

Jan 26, 2026

Study Design

Enrollment

10 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: MBX 1416 (INN imapextide)
  Single subcutaneous administration at different dose levels

Primary Outcome Measure

Changes from baseline to post-treatment in glucose nadir during a standardized MMTT following different dose levels of MBX 1416. [ Time Frame: The duration of the study will be approximately 67 days from screening to end of study (EoS) for any given participant ]

Central Contacts

• Elisa Fabbrini, MD, PhD
  844-877-4473
  [email protected]
• Stewart Hallett
  844-877-4473
  [email protected]

Locations (4)

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