Phase 2 Randomized Single Ascending Dose Study in Post-Bariatric Hypoglycemia Subjects to Determine the Effect of Mizagliflozin Formulations on Postprandial Glucose and Insulin Levels

  • STATUS
    Recruiting
  • days left to enroll
    23
  • participants needed
    9
  • sponsor
    Vogenx, Inc.
Updated on 28 October 2022

Summary

This clinical study will examine the safety and tolerability, as well as the effects of orally administered mizagliflozin on post prandial glucose and insulin levels in subjects diagnosed with post-bariatric hypoglycemia (PBH).

Description

This is a Phase 2 randomized, sequential crossover single ascending dose study in PBH subjects to determine the effect of two mizagliflozin formulations This study will examine single doses of mizagliflozin in either a liquid or encapsulated formulation. Subjects will be randomly assigned to one of two treatment arms. Safety, tolerability and pharmacodynamic response to mizagliflozin will be assessed in subjects during a mixed meal tolerance test (MMTT).

Details
Condition Postbariatric Hypoglycemia
Treatment Mizagliflozin
Clinical Study IdentifierNCT05541939
SponsorVogenx, Inc.
Last Modified on28 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Roux-en-Y gastric bypass surgery performed > 6 months prior to enrollment
Diagnosis of PBH

Exclusion Criteria

History of current medical conditions (other than PBH) which may result in hypoglycemia such as insulinoma, adrenal insufficiency, insulin autoimmune hypoglycemia, congenital hyperinsulinemia
Current use of insulin or insulin secretagogues
History of current dumping syndrome
History of current fasting hypoglycemia
Pregnancy and/ or Lactation: For women of childbearing potential: there is a requirement for a negative urine pregnancy test and for agreement to use contraception during the study and for at least 2 weeks after participating in the study
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