Study to Evaluate Efficacy and Dose Response of Imapextide (STEADI)
NCT ID: NCT07029412
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
10 participants
INTERVENTIONAL
2025-08-26
2026-01-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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MBX 1416 (INN imapextide)
Single subcutaneous administration at different dose levels
MBX 1416 (INN imapextide)
A single subcutaneous injection of MBX 1416 at a low dose and a high dose approximately 2 weeks apart.
Interventions
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MBX 1416 (INN imapextide)
A single subcutaneous injection of MBX 1416 at a low dose and a high dose approximately 2 weeks apart.
Eligibility Criteria
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Inclusion Criteria
2. Participants must have undergone RYGB or SG surgery at least 12 months prior to study entry.
3. 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.
4. 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.
5. Participants must have a body mass index (BMI) \<45 kg/m2 at screening.
6. Must have signed informed consent.
Exclusion Criteria
2. Currently on-going type II diabetes mellitus.
3. History of hypoglycemia prior to bariatric surgery.
4. History of insulinoma or other endogenous hyperinsulinemia illness (e.g., congenital hyperinsulinism).
18 Years
75 Years
ALL
No
Sponsors
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MBX Biosciences
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Other Identifiers
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MBX-1P2002
Identifier Type: -
Identifier Source: org_study_id