Effect of Mizagliflozin on Hypoglycemia in Patients With Post-Bariatric Hypoglycemia

NCT07760961 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: VGX-001-013
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Number of combined Level 2 (as measured by self-monitored blood glucose) and Level 3 hypoglycemic events (as measured by diary entry and adjudicated)

  During the double-blind treatment period (approximately 28 days)

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Mizagliflozin 5mg

EXPERIMENTAL

Drug: Mizagliflozin 5 mg

Mizagliflozin 10mg

EXPERIMENTAL

Drug: Mizagliflozin 10 mg

Interventions

Mizagliflozin 5 mg DRUG

5mg mizagliflozin capsules orally administered TID for 28 days

Mizagliflozin 5mg

Mizagliflozin 10 mg DRUG

10mg mizagliflozin capsules orally administered TID for 28 days

Mizagliflozin 10mg

Placebo DRUG

Placebo capsules orally administered TID for 28 days

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vogenx, Inc.: lead

MeSH Terms

Interventions

mizagliflozin

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sponsor
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2026
• First Posted: August 12, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: August 12, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share