36 Participants NeededMy employer runs this trial

Mizagliflozin for Post-Bariatric Hypoglycemia

(EMERGE Trial)

Recruiting at 10 trial locations
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, mizagliflozin, to determine if it can safely prevent low blood sugar in individuals who have undergone Roux-en-Y bariatric surgery and experience post-bariatric hypoglycemia. The study compares two different doses of mizagliflozin with a placebo (a pill with no active drug) to identify the most effective option. Individuals who had this type of surgery over a year ago and frequently experience low blood sugar episodes might be suitable candidates.

As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

Is there any evidence suggesting that mizagliflozin is likely to be safe for humans?

Research has shown that mizagliflozin is generally safe for patients. Studies examining repeated use of the drug found that common side effects were similar to those of a placebo, a harmless pill used for comparison. This indicates that negative reactions did not significantly differ from those experienced by people not taking the drug. Additionally, no major safety issues were reported. Some individuals might experience mild stomach problems, but these were not more severe than those observed in placebo recipients. This suggests mizagliflozin may be safe for many, though individual reactions can vary.12345

Why do researchers think this study treatment might be promising?

Most treatments for post-bariatric hypoglycemia focus on dietary changes and medications like acarbose that slow carbohydrate absorption. However, Mizagliflozin is unique because it targets the renal glucose transport system. This new mechanism of action helps reduce blood sugar spikes by promoting glucose excretion through urine. Researchers are excited about Mizagliflozin because it offers a novel way to manage blood sugar levels, potentially providing a more effective and convenient option for patients struggling with this condition.

What evidence suggests that mizagliflozin might be an effective treatment for post-bariatric hypoglycemia?

Research has shown that mizagliflozin may help treat low blood sugar in individuals who have undergone weight loss surgery. In this trial, participants will receive either a placebo or mizagliflozin at doses of 5mg or 10mg. Studies found that mizagliflozin can lower peak blood sugar levels by 21% and reduce severe low blood sugar episodes by 50% to 67%, depending on the dose. Importantly, these benefits occurred without major side effects. This suggests mizagliflozin could be a useful treatment for managing low blood sugar after bariatric surgery.678910

Are You a Good Fit for This Trial?

This trial is for adults (18+) who had Roux-en-Y bariatric surgery over a year ago and now have frequent episodes of low blood sugar with symptoms like confusion or fainting, confirmed by lab tests. Participants must be able to consent, follow study rules, and use contraception.

Inclusion Criteria

I am 18 or older and had Roux-en-Y surgery over a year ago.
* Willing and able to give informed consent and follow all study procedures and requirements.
I have had at least 4 episodes of low blood sugar in the past 3 weeks.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive mizagliflozin or placebo to evaluate its effect on hypoglycemia

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Mizagliflozin

Trial Overview

The study is testing two doses of mizagliflozin (5 mg and 10 mg) compared to a placebo to see if the drug can safely prevent low blood sugar in people with post-bariatric hypoglycemia. Participants are randomly assigned to one of the groups.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Placebo Group

Group I: Mizagliflozin 5mgExperimental Treatment1 Intervention
Group II: Mizagliflozin 10mgExperimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Vogenx, Inc.

Lead Sponsor

Trials
2
Recruited
20+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/42670480/

A single dose trial of mizagliflozin for the treatment ...

Conclusion: Mizagliflozin resulted in improved glucose nadir, reduction in both postprandial peak glucose and peak insulin, and reduction in ...

A single dose trial of mizagliflozin for the treatment of ...

mizagliflozin (all capsule doses combined) raised the glucose nadir by 38% Treatment with mizagliflozin also lowered both peak glucose by 21% ( ...

Vogenx Announces Positive Results From Second Phase 2 ...

These data suggest mizagliflozin is effective in preventing hypoglycemic events without significantly impacting blood glucose levels in patients ...

OR08-04 Efficacy and Safety of the SGLT1 Inhibitor ... - PMC

treatment with Mizagliflozin led to clinically meaningful improvements in postprandial glucose and insulin, and reductions in Level 3 and Level ...

Effect of Mizagliflozin on Hypoglycemia in Patients With ...

Most clinical studies have one primary outcome measure, but some have more than one. ... The main reason for the clinical trial. The types of primary purpose are: ...

Effect of Mizagliflozin Repeat Dosing on Adverse Events a...

This study will examine repeat doses of mizagliflozin and placebo while also evaluating dosing regimen. Up to 15 subjects are expected to ...

Vogenx Initiates Phase 2b EMERGE Study of Mizagliflozin ...

The study will evaluate the safety and tolerability of mizagliflozin and its ability to reduce hypoglycemia, with glucose monitored continuously ...

SUN-619 Outpatient Treatment of Post-Bariatric Hypoglycemia ...

Compared to before canagliflozin, there was no significant reduction in postprandial hyperglycemic events with BG > 180 mg/dL (p = 0.48), ...

Vogenx Initiates Phase 2b EMERGE Study of Mizagliflozin ...

The study will evaluate the safety and tolerability of mizagliflozin and its ability to reduce hypoglycemia, with glucose monitored continuously ...

Study Details | NCT05036317 | Empagliflozin for the ...

This randomized trial is to test whether a treatment with empagliflozin is superior to placebo in patients with postprandial hypoglycemia after bariatric ...