Health TrialsbyHealthPanel

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

ConditionPostbariatric Hypoglycemia
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorVogenx, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mizagliflozin 5 mg

    Drug

    5mg mizagliflozin capsules orally administered TID for 28 days

  • Mizagliflozin 10 mg

    Drug

    10mg mizagliflozin capsules orally administered TID for 28 days

  • Placebo

    Drug

    Placebo capsules orally administered TID for 28 days

Treatment groups

36 Participants
are divided into 3 treatment groups
Group A: PlaceboPlacebo comparator 1 intervention
Group B: Mizagliflozin 5mgExperimental treatment 1 intervention
Group C: Mizagliflozin 10mgExperimental treatment 1 intervention

Trial outcomes

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)

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

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vogenx, Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: