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RecruitingNCT07760961EMERGEUpdated Nov 5, 2026

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

A Phase 2 interventional study of Mizagliflozin 5 mg and Mizagliflozin 10 mg in Postbariatric Hypoglycemia, sponsored by Vogenx, Inc.. Recruiting at 11 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.

Sponsored by Vogenx, Inc. · Phase 2, Interventional, and Treatment

Updated Oct 26, 2026Now RecruitingFirst site in United States+1 moreGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Postbariatric Hypoglycemia

Browse trials for

03

In context

Hypoglycemia

706 studies on the registry are indexed under Hypoglycemia; 94 are open to participants now.

This study's planned enrollment of 36 is above the median of 28 across 534 interventional studies indexed under Hypoglycemia.

Browse Hypoglycemia studies →

Lead sponsor

Vogenx, Inc. is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 and follow all study procedures and requirements.
  • Participants (male and female) must agree to use an adequate method of
  • Has recurrent hypoglycemia of at least 4 episodes during a 3-week Run-In period.

Exclusion criteria

Exclusion Criteria:

  • 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, 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 , 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 : there is a requirement for a negative urine pregnancy test and for agreement to use during the study and for at least 2 weeks after participating in the study.
  • Other participants considered by the investigator to be inappropriate.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
36 participants (estimated)

Study arms

  • Placebo comparator
    Placebo

    Drug: Placebo

  • Experimental
    Mizagliflozin 5mg

    Drug: Mizagliflozin 5 mg

  • Experimental
    Mizagliflozin 10mg

    Drug: Mizagliflozin 10 mg

Interventions

  • 5mg mizagliflozin capsules orally administered TID for 28 days

  • 10mg mizagliflozin capsules orally administered TID for 28 days

  • DrugPlacebo

    Placebo capsules orally administered TID for 28 days

06

What researchers measure

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)

07

Study locations

3 of 11 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

3 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2026 (actual). Primary completion is estimated for Oct 2027, 12 months after the start.

Of 24 phase 2 interventional studies under Hypoglycemia, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 31. This study's planned 12 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 7, 2026
First posted
Aug 12, 2026
StartActual
Oct 20, 2026
Primary completionEst.
Oct 2027
CompletionEst.
Jan 2028
Last update
Nov 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting
changed Oct 26, 2026
Sites
11 sites added — first site in United States
Show 11 added (11 United States)
  • Exalt Clinical Research · Chula Vista, United States
  • Stanford · Palo Alto, United States
  • U Colorado- Anschutz Medical Campus · Aurora, United States
  • DM Clinical- Miami · Doral, United States
  • Georgia Clinical Research · Lawrenceville, United States
  • Centricity Research · Morehead City, United States
  • Penn Medicine · Philadelphia, United States
  • Vanderbilt Weight Loss Center · Nashville, United States
  • DM Clinical- Irving · Irving, United States
  • UT San Antonio · San Antonio, United States
  • Texas Valley Clinical Research · Weslaco, United States
Oct 26, 2026
Show all 3 updates
  1. Nov 5, 2026
    Minor edits only
    + 2 other changes: verification date and date precision
  2. Oct 29, 2026
    Minor edits only
    + 1 other change: registry dates
  3. Oct 26, 2026
    Not yet recruiting→Recruiting
    11 sites added — first site in United States
    Show 11 added (11 United States)
    • Exalt Clinical Research · Chula Vista, United States
    • Stanford · Palo Alto, United States
    • U Colorado- Anschutz Medical Campus · Aurora, United States
    • DM Clinical- Miami · Doral, United States
    • Georgia Clinical Research · Lawrenceville, United States
    • Centricity Research · Morehead City, United States
    • Penn Medicine · Philadelphia, United States
    • Vanderbilt Weight Loss Center · Nashville, United States
    • DM Clinical- Irving · Irving, United States
    • UT San Antonio · San Antonio, United States
    • Texas Valley Clinical Research · Weslaco, United States
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07760961
Lead sponsor
Vogenx, Inc.
Responsible party
Sponsor
First posted
Aug 12, 2026
Start date
Oct 20, 2026
Primary completion
Oct 2027 (estimated)
Completion
Jan 2028 (estimated)
Last update
Nov 5, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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Discussion

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Studies of the drug tested here: Mizagliflozin

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