NCT07760961 · Vogenx, Inc.
Effect of Mizagliflozin on Hypoglycemia in Patients With Post-Bariatric Hypoglycemia
(EMERGE)
What this study is about
VGX-001-013 (EMERGE) is a Phase 2b study to evaluate an experimental new drug, mizagliflozin, for safety, tolerability and its ability to prevent low blood sugar in patients with post-bariatric hypoglycemia.
View original scientific description
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.
Interventions
DRUG
Mizagliflozin 5 mg
5mg mizagliflozin capsules orally administered TID for 28 days
DRUG
Mizagliflozin 10 mg
10mg mizagliflozin capsules orally administered TID for 28 days
DRUG
Placebo
Placebo capsules orally administered TID for 28 days
Primary outcome measures
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)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Chula Vista, California
- Palo Alto, California
- Aurora, Colorado
- Doral, Florida
- Lawrenceville, Georgia
- Morehead City, North Carolina
- Philadelphia, Pennsylvania
- Nashville, Tennessee
- Irving, Texas
- San Antonio, Texas
- Weslaco, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 26, 2026 · Source of record for eligibility and locations