Actively Recruiting
Study to Evaluate Efficacy and Dose Response of Imapextide (STEADI)
Led by MBX Biosciences · Updated on 2025-12-17
10
Participants Needed
4
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Study to Evaluate Efficacy and Dose Response of Imapextide (STEADI)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years at informed consent
- Underwent Roux-en-Y gastric bypass or sleeve gastrectomy at least 12 months before study entry
- Documented history of postbariatric hypoglycemia with symptomatic hypoglycemia, blood glucose ≤54 mg/dL, and symptom improvement after carbohydrate
- At least one symptomatic hypoglycemic episode per month reported by patient
- Treatment naive or discontinued medications affecting glucose metabolism before screening
- Body mass index (BMI) less than 45 kg/m2 at screening
- Signed informed consent
You will not qualify if you...
- History of or current significant illness that may prevent study participation
- Currently diagnosed with type II diabetes mellitus
- History of hypoglycemia before bariatric surgery
- History of insulinoma or other endogenous hyperinsulinemia conditions such as congenital hyperinsulinism
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
MBX Biosciences Investigational Site
Aurora, Colorado, United States, 80045
Actively Recruiting
2
MBX Biosciences Investigational Site
Morehead City, North Carolina, United States, 28557
Actively Recruiting
3
MBX Biosciences Investigational Site
Knoxville, Tennessee, United States, 37920
Actively Recruiting
4
MBX Biosciences Investigational Site
San Antonio, Texas, United States, 78229
Actively Recruiting
Research Team
E
Elisa Fabbrini, MD, PhD
CONTACT
S
Stewart Hallett
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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