Effect of Mizagliflozin Repeat Dosing on Adverse Events and Postprandial Glucose Excursions

• ClinicalTrials.gov Identifier: NCT05721729
• Recruitment Status: Active, not recruiting
• First Posted: February 10, 2023
• Last Update Posted: March 20, 2024
• Sponsor: Vogenx, Inc.
• Information provided by (Responsible Party): Vogenx, Inc.

Tracking Information

• First Submitted Date: January 31, 2023
• First Posted Date: February 10, 2023
• Last Update Posted Date: March 20, 2024
• Actual Study Start Date: June 23, 2023
• Estimated Primary Completion Date: May 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 31, 2023)

• Adverse Events [ Time Frame: Through study completion, 43 days ]
  Number of participants with adverse events
• Vital Signs [ Time Frame: Through study completion, 43 days ]
  Number of participants with abnormal vital signs
• Laboratory Tests [ Time Frame: Through study completion, 43 days ]
  Number of participants with abnormal laboratory tests
• Glucose nadir after dosing [ Time Frame: 0-3 hours following liquid meal ]
  Time course of glucose concentrations during MMTT

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: January 31, 2023)

• MMTT peak glucose concentration after dosing [ Time Frame: 0-3 hours following liquid meal ]
  Time course of glucose concentrations during MMTT
• MMTT peak insulin concentration after dosing [ Time Frame: 0-3 hours following liquid meal ]
  Time course of insulin concentrations during MMTT
• MMTT time to peak glucose concentration after dosing [ Time Frame: 0-3 hours following liquid meal ]
  Time course of glucose concentrations during MMTT
• MMTT time to peak insulin concentration after dosing [ Time Frame: 0-3 hours following liquid meal ]
  Time course of insulin concentrations during MMTT
• MMTT glucose concentration [ Time Frame: 0-3 hours following liquid meal ]
  MMTT glucose area under the curve (AUC0-1, AUC0-2, and AUC0-3) after dosing
• MMTT insulin concentration [ Time Frame: 0-3 hours following liquid meal ]
  MMTT insulin area under the curve (AUC0-1, AUC0-2, and AUC0-3) after dosing

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effect of Mizagliflozin Repeat Dosing on Adverse Events and Postprandial Glucose Excursions
• Official Title: Phase 2 Crossover, Randomized, Placebo-Controlled, Single-Blind, Repeat Dose Study in Post-Bariatric Hypoglycemia Subjects to Determine the Effect of Mizagliflozin on Adverse Events and Postprandial Glucose Excursions
• Brief Summary: This is a phase 2 crossover, randomized, placebo-controlled, single-blind, repeat dose study in PBH subjects to determine the effect of mizagliflozin on adverse events and postprandial glucose excursions.
• Detailed Description: This is a phase 2 crossover, randomized, placebo-controlled, single-blind, repeat dose study in PBH subjects to determine the effect of mizagliflozin on adverse events and postprandial glucose excursions. This study will examine repeat doses of mizagliflozin and placebo while also evaluating dosing regimen. Up to 15 subjects are expected to complete the study. Subjects will be randomly assigned to a treatment arm within a cohort. Each subject should receive placebo and 2 active dose regimens in a crossover fashion.
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
• Condition: Postbariatric Hypoglycemia

Intervention

• Drug: Mizagliflozin
  Encapsulated
• Drug: Placebo
  Encapsulated

Study Arms

• Experimental: Cohort 1
  Subjects will receive placebo and two doses of encapsulated mizagliflozin over three dosing periods. Once and twice daily dosing will be examined.
  Interventions:

  • Drug: Mizagliflozin
  • Drug: Placebo
• Experimental: Cohort 2
  Subjects will receive placebo and two doses of encapsulated mizagliflozin over three dosing periods. Twice and three times daily dosing will be examined.
  Interventions:

  • Drug: Mizagliflozin
  • Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: January 31, 2023): 15
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: August 2024
• Estimated Primary Completion Date: May 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Roux-en-Y gastric bypass surgery performed > 6 months prior to enrollment
• Diagnosis of PBH

Exclusion Criteria:

• History of current medical conditions (other than PBH) which may result in hypoglycemia such as insulinoma, adrenal insufficiency, insulin autoimmune hypoglycemia, congenital hyperinsulinemia.
• Current use of insulin or insulin secretagogues
• History of current fasting hypoglycemia
• 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05721729
• Other Study ID Numbers: VGX-001-012
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Vogenx, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Vogenx, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Vogenx, Inc.
• Verification Date: March 2024