Recruiting
Phase 2

Mizagliflozin

Sponsor:

Vogenx, Inc.

Code:

NCT07760961

Conditions

Postbariatric Hypoglycemia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Mizagliflozin 5 mg

Mizagliflozin 10 mg

Placebo

Study Details

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.

Conditions

Postbariatric Hypoglycemia

Study ID

NCT07760961

Start date

Oct, 2026

Status verified date

Oct, 2026

Completion date

Jan, 2028

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

36 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Placebo

experimental: Mizagliflozin 5mg

experimental: Mizagliflozin 10mg

Interventions

Mizagliflozin 5 mg

5mg mizagliflozin capsules orally administered TID for 28 days

Mizagliflozin 10 mg

10mg mizagliflozin capsules orally administered TID for 28 days

Placebo

Placebo capsules orally administered TID for 28 days

Primary outcome measure

  • 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) ]

Central Contacts and Locations

Locations

Exalt Clinical Research

Recruiting

Chula Vista, California, United States, 91910

Contacts

Tiffany Hecklinski

619-826-8884tiffany@exaltresearch.com

Centricity Research

Recruiting

Morehead City, North Carolina, United States, 28557

Contacts

Rachel Gratz

252-222-5700rachel.gratz@centricityresearch.com

Texas Valley Clinical Research

Recruiting

Weslaco, Texas, United States, 78596

Contacts

Gabriela Echiveste

956-554-4003gabriela@tvcrtrials.com

More Information

Sponsor

Vogenx, Inc.

Last update posted

Oct 26, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-27. This information was provided to ClinicalTrials.gov by Vogenx, Inc. on 2026-10-26. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.