Postbariatric HypoglycemiaPhase 2EMERGENCT07760961
Effect of Mizagliflozin on Hypoglycemia in Patients With Post-Bariatric Hypoglycemia
A Phase 2 study testing Mizagliflozin 5 mg and Mizagliflozin 10 mg in people with Postbariatric Hypoglycemia, run by Vogenx, Inc. at 11 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postbariatric Hypoglycemia
- What is being tested?
- Mizagliflozin 5 mg and Mizagliflozin 10 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 11 sitesUnited States
- Study dates
- 20 Oct 2026to Jan 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
United States11 sites, 11 recruiting
- Not yet recruiting
U Colorado- Anschutz Medical Campus
Aurora, Colorado, 80045
- Recruiting
Exalt Clinical Research
Chula Vista, California, 91910
Tiffany Hecklinski, 619-826-8884, tiffany@exaltresearch.com
- Not yet recruiting
DM Clinical- Miami
Doral, Florida, 33166
- Not yet recruiting
DM Clinical- Irving
Irving, Texas, 75063
- Not yet recruiting
Georgia Clinical Research
Lawrenceville, Georgia, 30044
- Recruiting
Centricity Research
Morehead City, North Carolina, 28557
Rachel Gratz, 252-222-5700, rachel.gratz@centricityresearch.com
- Not yet recruiting
Vanderbilt Weight Loss Center
Nashville, Tennessee, 37204
- Not yet recruiting
Stanford
Palo Alto, California, 94304
- Not yet recruiting
Penn Medicine
Philadelphia, Pennsylvania, 19104
- Not yet recruiting
UT San Antonio
San Antonio, Texas, 78229
- Recruiting
Texas Valley Clinical Research
Weslaco, Texas, 78596
Gabriela Echiveste, 956-554-4003, gabriela@tvcrtrials.com
About this study
Official title: Phase 2B Randomized, Placebo-Controlled, Double-Blind, Repeat Dose Parallel Study in Participants With Post-Bariatric Hypoglycemia to Determine the Effect of Mizagliflozin on Hypoglycemia
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.
Read the detailed description
This is a phase 2b randomized, placebo-controlled, double-blind, repeat dose parallel group study in patients with post-bariatric hypoglycemia (PBH) to determine the effect of mizagliflozin on safety, postprandial glucose excursions and reduction in hypoglycemic events.
- Conditions
- Postbariatric Hypoglycemia
- Being tested
- Mizagliflozin 5 mg, Mizagliflozin 10 mg, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mizagliflozin 5 mgDrug
5mg mizagliflozin capsules orally administered TID for 28 days
Mizagliflozin 10 mgDrug
10mg mizagliflozin capsules orally administered TID for 28 days
PlaceboDrug
Placebo capsules orally administered TID for 28 days
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Mizagliflozin 5mg | Experimental | Not described Receives: Drug: Mizagliflozin 5 mg |
| Mizagliflozin 10mg | Experimental | Not described Receives: Drug: Mizagliflozin 10 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of combined Level 2 (as measured by self-monitored blood glucose) and Level 3 hypoglycemic events (as measured by diary entry and adjudicated)
Measured: During the double-blind treatment period (approximately 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start20 Oct 2026
- Primary completionOct 2027 (estimated)
- Study completionJan 2028 (estimated)
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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vogenx, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07760961
- Sponsor's protocol ID
- VGX-001-013
- Acronym
- EMERGE
- Status last verified
- Nov 2026
- First submitted
- 7 Aug 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2B Randomized, Placebo-Controlled, Double-Blind, Repeat Dose Parallel Study in Participants With Post-Bariatric Hypoglycemia to Determine the Effect of Mizagliflozin on Hypoglycemia
- ClinicalTrials.gov ID
- NCT07760961
- Acronym / sponsor ID
- EMERGE / VGX-001-013
- Conditions
- Postbariatric Hypoglycemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Vogenx, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Oct 2026 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 12 Aug 2026 (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.
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.
Detailed description
This is a phase 2b randomized, placebo-controlled, double-blind, repeat dose parallel group study in patients with post-bariatric hypoglycemia (PBH) to determine the effect of mizagliflozin on safety, postprandial glucose excursions and reduction in hypoglycemic events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Mizagliflozin 5mg | Experimental | Drug: Mizagliflozin 5 mg |
| Mizagliflozin 10mg | Experimental | Drug: Mizagliflozin 10 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
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 |
|---|---|---|
| Mizagliflozin 5 mg5mg mizagliflozin capsules orally administered TID for 28 days | Drug | Mizagliflozin 5mg |
| Mizagliflozin 10 mg10mg mizagliflozin capsules orally administered TID for 28 days | Drug | Mizagliflozin 10mg |
| PlaceboPlacebo capsules orally administered TID for 28 days | Drug | Placebo |
Primary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: No
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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.
11 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 5 mg and Mizagliflozin 10 mg in people with Postbariatric Hypoglycemia, run by Vogenx, Inc. at 11 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 5 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the 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)). 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 5 Nov 2026.