Imapextide dose-response test for postbariatric hypoglycemia

A Phase 2a, Open-label, Exploratory Study to Evaluate Preliminary Efficacy of Subcutaneous MBX 1416 in Patients With Postbariatric Hypoglycemia (The STEADI Study)

This will test whether a single under-the-skin dose of imapextide can raise post-meal blood sugar in adults with postbariatric hypoglycemia.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: MBX Biosciences (Industry-sponsored)
• Locations: 4 sites (Aurora, Colorado and 3 other locations)
• Trial ID: NCT07029412 on ClinicalTrials.gov

What this trial studies

This Phase 2a, open-label exploratory study will give single subcutaneous doses of MBX 1416 (imapextide) at different dose levels to about 10 adults with postbariatric hypoglycemia. Participants must be 18–75 years old and have had Roux-en-Y or sleeve gastrectomy at least 12 months earlier. Each participant will undergo three mixed-meal tolerance tests: one at baseline and one 48 hours after each MBX 1416 administration, to measure post-prandial glucose nadir and insulin and C‑peptide peaks. The goal is to see whether imapextide can raise the post-meal glucose nadir and reduce post-meal insulin and C‑peptide responses.

Who should consider this trial

Good fit: Adults 18–75 years who had Roux-en-Y or sleeve gastrectomy at least 12 months ago, have documented PBH with at least one symptomatic hypoglycemic episode per month, BMI <45 kg/m2, and who can stop glucose‑altering medications are ideal candidates.

Not a fit: People with active significant medical illnesses, those unable to discontinue glucose‑altering medications, or those without documented PBH are unlikely to receive benefit.

Why it matters

Potential benefit: If successful, imapextide could reduce post-meal low blood sugar episodes and improve daily safety and quality of life for people with PBH.

How similar studies have performed: This peptide therapy approach for PBH is relatively novel with limited prior clinical data, so larger successful studies have not yet been established.

Eligibility criteria

Inclusion Criteria:

1. Participant must be ≥18 to ≤75 years of age at the time of signing the informed consent.
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:

1. 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.
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).

Where this trial is running

Aurora, Colorado and 3 other locations

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

Study contacts

• Study coordinator: Elisa Fabbrini, MD, PhD

Conditions Postbariatric Hypoglycemia; PBH