RecruitingPhase 2NCT07029412
Study to Evaluate Efficacy and Dose Response of Imapextide (STEADI)
A Phase 2a, Open-label, Exploratory Study to Evaluate Preliminary Efficacy of Subcutaneous MBX 1416 in Patients With Postbariatric Hypoglycemia (The STEADI Study)
Sponsor
MBX Biosciences
Enrollment
10 participants
Start Date
Aug 26, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
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
Eligibility
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria6
- 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.
Exclusion Criteria4
- 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).
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Interventions
DRUGMBX 1416 (INN imapextide)
A single subcutaneous injection of MBX 1416 at a low dose and a high dose approximately 2 weeks apart.
Locations(4)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07029412