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

Completed · Phase 2

Conditions studied: Postbariatric Hypoglycemia

In brief

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 facts

Study ID

NCT07029412

Run by

MBX Biosciences

People needed

20

Starts

2025-08-26

Expected to finish

2026-05-01

Last updated by the study team

2026-07-02

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant must be ≥18 to ≤75 years of age at the time of signing the informed consent.
• Participants must have undergone RYGB or SG surgery at least 12 months prior to study entry.
• Participants should have a documented history of PBH, defined as Whipple's triad (symptomatic hypoglycemia, capillary glucose ≤54 mg/dL, with symptom resolution by carbohydrate administration) and a minimum of 1 symptomatic hypoglycemic episode per month by patient report.
• Participants who are either treatment naïve or who are no longer using (i.e., have discontinued as part of their usual medical care) agents known to interfere with glucose metabolism at the time of screening.
• Participants must have a body mass index (BMI) <45 kg/m2 at screening.
• Must have signed informed consent.

You may not qualify if…

• 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.
• Currently on-going type II diabetes mellitus.
• History of hypoglycemia prior to bariatric surgery.
• History of insulinoma or other endogenous hyperinsulinemia illness (e.g., congenital hyperinsulinism).

Where it is running

• MBX Biosciences Investigational Site — Aurora, Colorado, United States
• MBX Biosciences Investigational Site — Morehead City, North Carolina, United States
• MBX Biosciences Investigational Site — Knoxville, Tennessee, United States
• MBX Biosciences Investigational Site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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