RecruitingPhase 2

Study to Evaluate Efficacy and Dose Response of Imapextide (STEADI)

United States10 participantsStarted 2025-08-26

Plain-language 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

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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).

Changes from baseline to post-treatment in glucose nadir during a standardized MMTT following different dose levels of MBX 1416.

Timeframe: The duration of the study will be approximately 67 days from screening to end of study (EoS) for any given participant

NCT IDNCT07029412

SponsorMBX Biosciences

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12-22

Elisa Fabbrini, MD, PhD

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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).