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โ† Trials
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Effect of Mizagliflozin on Hypoglycemia in Patients With Post-Bariatric Hypoglycemia

RecruitingPhase 2Ages 18 Years - anyAllVogenx, Inc.
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In plain words

What the trial is, and whether it could suit you

VGX-001-013 (EMERGE) is a Phase 2b study to evaluate an investigational new drug, mizagliflozin, for safety, tolerability and its ability to prevent low blood sugar in patients with post-bariatric hypoglycemia.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Males and nonpregnant females, ages โ‰ฅ18 years old, having had Roux-en-Y bariatric surgery more than 12 months prior to signing the ICF. * History of reactive hypoglycemia with Whipple's triad: the occurrence of hypoglycemic symptoms associated with blood glucose of \<54 mg/dL, and resolution with glucose or carbohydrate administration. Symptoms associated with reactive hypoglycemia include neuroglycopenic symptoms (e.g., behavioral changes, confusion or impaired cognitive function, seizure, loss of consciousness). * Willing and able to give informed consent and follow all study procedures and requirements. * Participants (male and female) must agree to use an adequate method of contraception * Has recurrent hypoglycemia of at least 4 episodes during a 3-week Run-In period. Exclusion Criteria: * History of current medical conditions excluding PBH which may result in hypoglycemia). * Current use of insulin or insulin secretagogues. * Current use of GLP-1 agonists, GLP-1/GIP dual agonists, or GLP-1 antagonists. Unless participants have been through a 'wash-out' period * Current use of drugs that may affect CGM function (e.g., acetaminophen/paracetamol). * History of recent fasting hypoglycemia. * Participants with rectal prolapse or pelvic floor dysfunction within 6 months of Screening. * Congestive heart failure, New York Heart Association class II, III or IV within 6 months of Screening. * History of myocardial infarction, unstable angina, or revascularization within 6 months of Screening. * History of a cerebrovascular accident within 6 months of Screening. * Active malignancy, except basal cell or squamous cell skin cancers. * Major surgical operation within 30 days of Screening. * Active alcohol abuse or substance abuse. * 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. * Other participants considered by the investigator to be inappropriate.
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What it tests

  • Mizagliflozin 5 mg
  • Mizagliflozin 10 mg
  • Placebo
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Where

11 sites
Exalt Clinical Research
Chula Vista, United States
Stanford
Palo Alto, United States
U Colorado- Anschutz Medical Campus
Aurora, United States
DM Clinical- Miami
Doral, United States
Georgia Clinical Research
Lawrenceville, United States
Centricity Research
Morehead City, United States
Penn Medicine
Philadelphia, United States
Vanderbilt Weight Loss Center
Nashville, United States

โ€ฆand 3 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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