NCT07760961Not yet recruitingPhase 2
Phase 2B Randomized, Placebo-Controlled, Double-Blind, Repeat Dose Parallel Study in Participants With Post-Bariatric Hypoglycemia to Determine the Effect of Mizagliflozin on Hypoglycemia
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Vogenx, Inc.
- Enrollment
- 36
- Primary Endpoint
- Number of combined Level 2 (as measured by self-monitored blood glucose) and Level 3 hypoglycemic events (as measured by diary entry and adjudicated)
Study Overview
Brief Summary
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.
Detailed Description
This is a phase 2b randomized, placebo-controlled, double-blind, repeat dose parallel group study in patients with post-bariatric hypoglycemia (PBH) to determine the effect of mizagliflozin on safety, postprandial glucose excursions and reduction in hypoglycemic events.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Sponsor
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Males and nonpregnant females, ages ≥18 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.
Arms & Interventions
Placebo
Placebo Comparator
Intervention: Placebo (Drug)
Mizagliflozin 5mg
Experimental
Intervention: Mizagliflozin 5 mg (Drug)
Mizagliflozin 10mg
Experimental
Intervention: Mizagliflozin 10 mg (Drug)
Outcomes
Primary Outcomes
Number of combined Level 2 (as measured by self-monitored blood glucose) and Level 3 hypoglycemic events (as measured by diary entry and adjudicated)
Time Frame: During the double-blind treatment period (approximately 28 days)
Secondary Outcomes
No secondary outcomes reported
Investigators
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