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

Conditions: Postbariatric Hypoglycemia

Sex: All

Ages: 18 Years – 75 Years

Healthy volunteers: No

Phase: PHASE2

Enrollment: 20

Sponsor: MBX Biosciences

Location: MBX Biosciences Investigational Site Aurora Colorado

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

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) \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07029412). StuddyBuddy aggregates publicly available trial information.