Postbariatric HypoglycemiaPhase 2NCT05721729
Effect of Mizagliflozin Repeat Dosing on Adverse Events and Postprandial Glucose Excursions
A Phase 2 study testing Mizagliflozin in people with Postbariatric Hypoglycemia, run by Vogenx, Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postbariatric Hypoglycemia
- What is being tested?
- Mizagliflozin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 Jun 2023to 1 Jun 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Roux-en-Y gastric bypass surgery performed > 6 months prior to enrollment
- Diagnosis of PBH
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Colorado / Anschutz Medical Campus
Aurora, Colorado, 80045
Stanford
Palo Alto, California, 94304
About this study
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
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.
Read the 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.
- Conditions
- Postbariatric Hypoglycemia
- Being tested
- Mizagliflozin, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MizagliflozinDrug
Encapsulated
PlaceboDrug
Encapsulated
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Subjects will receive placebo and two doses of encapsulated mizagliflozin over three dosing periods. Once and twice daily dosing will be examined. Receives: Drug: Mizagliflozin; Drug: Placebo |
| Cohort 2 | Experimental | Subjects will receive placebo and two doses of encapsulated mizagliflozin over three dosing periods. Twice and three times daily dosing will be examined. Receives: Drug: Mizagliflozin; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Number of participants with adverse events
Measured: Through study completion, 43 days
Vital Signs
Number of participants with abnormal vital signs
Measured: Through study completion, 43 days
Laboratory Tests
Number of participants with abnormal laboratory tests
Measured: Through study completion, 43 days
Glucose nadir after dosing
Time course of glucose concentrations during MMTT
Measured: 0-3 hours following liquid meal
Secondary outcomes (6)
MMTT peak glucose concentration after dosing
Time course of glucose concentrations during MMTT
Measured: 0-3 hours following liquid meal
MMTT peak insulin concentration after dosing
Time course of insulin concentrations during MMTT
Measured: 0-3 hours following liquid meal
MMTT time to peak glucose concentration after dosing
Time course of glucose concentrations during MMTT
Measured: 0-3 hours following liquid meal
MMTT time to peak insulin concentration after dosing
Time course of insulin concentrations during MMTT
Measured: 0-3 hours following liquid meal
MMTT glucose concentration
MMTT glucose area under the curve (AUC0-1, AUC0-2, and AUC0-3) after dosing
Measured: 0-3 hours following liquid meal
MMTT insulin concentration
MMTT insulin area under the curve (AUC0-1, AUC0-2, and AUC0-3) after dosing
Measured: 0-3 hours following liquid meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start23 Jun 2023
- Primary completion1 May 2024
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postbariatric HypoglycemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vogenx, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05721729
- Sponsor's protocol ID
- VGX-001-012
- Status last verified
- Dec 2025
- First submitted
- 31 Jan 2023
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05721729
- Acronym / sponsor ID
- VGX-001-012
- Conditions
- Postbariatric Hypoglycemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Vogenx, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Jun 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 10 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Mizagliflozin, Drug: PlaceboSubjects will receive placebo and two doses of encapsulated mizagliflozin over three dosing periods. Once and twice daily dosing will be examined. |
| Cohort 2 | Experimental | Drug: Mizagliflozin, Drug: PlaceboSubjects will receive placebo and two doses of encapsulated mizagliflozin over three dosing periods. Twice and three times daily dosing will be examined. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Roux-en-Y gastric bypass surgery performed > 6 months prior to enrollment
- Diagnosis of PBH
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MizagliflozinEncapsulated | Drug | Cohort 1, Cohort 2 |
| PlaceboEncapsulated | Drug | Cohort 1, Cohort 2 |
Primary outcome
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
6 secondary outcomes
MMTT peak glucose concentration after dosing
Time frame: 0-3 hours following liquid meal
MMTT peak insulin concentration after dosing
Time frame: 0-3 hours following liquid meal
MMTT time to peak glucose concentration after dosing
Time frame: 0-3 hours following liquid meal
MMTT time to peak insulin concentration after dosing
Time frame: 0-3 hours following liquid meal
MMTT glucose concentration
Time frame: 0-3 hours following liquid meal
MMTT insulin concentration
Time frame: 0-3 hours following liquid meal
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mizagliflozin in people with Postbariatric Hypoglycemia, run by Vogenx, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: Through study completion, 43 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.