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)
1 other identifier
interventional
10
1 country
4
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Aug 2025
Shorter than P25 for phase_2
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 11, 2025
CompletedFirst Posted
Study publicly available on registry
June 19, 2025
CompletedStudy Start
First participant enrolled
August 26, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 22, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 26, 2026
CompletedDecember 17, 2025
December 1, 2025
4 months
June 11, 2025
December 11, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes from baseline to post-treatment in glucose nadir during a standardized MMTT following different dose levels of MBX 1416.
The duration of the study will be approximately 67 days from screening to end of study (EoS) for any given participant
Study Arms (1)
MBX 1416 (INN imapextide)
EXPERIMENTALSingle subcutaneous administration at different dose levels
Interventions
A single subcutaneous injection of MBX 1416 at a low dose and a high dose approximately 2 weeks apart.
Eligibility Criteria
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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MBX Bioscienceslead
Study Sites (4)
MBX Biosciences Investigational Site
Aurora, Colorado, 80045, United States
MBX Biosciences Investigational Site
Morehead City, North Carolina, 28557, United States
MBX Biosciences Investigational Site
Knoxville, Tennessee, 37920, United States
MBX Biosciences Investigational Site
San Antonio, Texas, 78229, United States
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2025
First Posted
June 19, 2025
Study Start
August 26, 2025
Primary Completion
December 22, 2025
Study Completion
January 26, 2026
Last Updated
December 17, 2025
Record last verified: 2025-12