Mizagliflozin for Low Blood Sugar

Not currently recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Vogenx, Inc.

Must not be taking: Insulin, Insulin secretagogues

Disqualifiers: Insulinoma, Adrenal insufficiency, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called mizagliflozin to determine its effects on individuals with post-bariatric hypoglycemia (PBH), a condition characterized by low blood sugar after eating. Researchers aim to discover if this treatment can reduce unwanted drops in blood sugar and related symptoms. Participants will receive varying doses to identify the most effective one. The trial seeks individuals who underwent gastric bypass surgery over six months ago and experience low blood sugar after meals. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial requires that you do not use insulin or medications that increase insulin production. If you are on these, you will need to stop taking them to participate.

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

Research has shown that mizagliflozin is generally safe for people. Earlier studies found no specific side effects related to its mechanism, including symptoms like hypoglycemia, meaning it did not cause dangerously low blood sugar levels. In another study, one person had a low blood sugar reading but experienced no symptoms.

Overall, mizagliflozin appears well-tolerated. It is designed to help control blood sugar without causing major side effects. For those considering joining a trial for mizagliflozin, this research suggests that the treatment is relatively safe based on past studies. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Mizagliflozin is unique because it targets low blood sugar differently than current treatments, like glucose tablets or gels, which provide direct sugar boosts. Mizagliflozin works by modulating renal glucose reabsorption, offering a novel mechanism that potentially stabilizes blood sugar levels more effectively over time. Researchers are excited about this treatment because it could provide a more consistent and sustained approach to managing low blood sugar, reducing the need for frequent interventions and enhancing overall glucose control.

What evidence suggests that mizagliflozin might be an effective treatment for low blood sugar?

Research shows that mizagliflozin, a type of medication, effectively lowers blood sugar and insulin levels after meals. Studies have demonstrated that it significantly reduces low blood sugar events without affecting blood sugar levels in those without low blood sugar. Additionally, mizagliflozin is safe for patients with constipation, with a low risk of causing low blood sugar. These findings suggest that mizagliflozin may help manage blood sugar levels after eating and reduce the risk of low blood sugar, making it a promising treatment for people with these issues. Participants in this trial will receive a placebo and two doses of encapsulated mizagliflozin over three dosing periods to further evaluate its effectiveness and safety. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals who have had Roux-en-Y gastric bypass surgery over 6 months ago and are diagnosed with post-bariatric hypoglycemia (PBH). Participants must not be pregnant, using insulin or drugs that increase insulin release, and should not have other conditions causing low blood sugar.

Inclusion Criteria

You had a specific type of stomach surgery more than 6 months ago.

You have been diagnosed with PBH.

Exclusion Criteria

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

You are currently taking insulin or certain medications that stimulate insulin production.

You have a medical condition that may cause low blood sugar, like insulinoma or adrenal insufficiency.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive placebo and two doses of encapsulated mizagliflozin in a crossover fashion

6 weeks

Multiple visits for dosing and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Mizagliflozin
• Placebo

Trial Overview The study tests the effects of Mizagliflozin—a drug—on adverse events and how it affects blood sugar levels after eating in people with PBH. It's a phase 2 trial where participants will receive either Mizagliflozin or a placebo without knowing which one they're getting.

How Is the Trial Designed?

Group I: Cohort 2 Experimental Treatment 2 Interventions

Subjects will receive placebo and two doses of encapsulated mizagliflozin over three dosing periods. Twice and three times daily dosing will be examined.

Group II: Cohort 1 Experimental Treatment 2 Interventions

Subjects will receive placebo and two doses of encapsulated mizagliflozin over three dosing periods. Once and twice daily dosing will be examined.

Who Is Running the Clinical Trial?

Vogenx, Inc.

Lead Sponsor

Trials

2

Recruited

20+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12543950/

OR08-04 Efficacy and Safety of the SGLT1 Inhibitor ... In conclusion, treatment with Mizagliflozin led to clinically meaningful improvements in postprandial glucose and insulin, and reductions in ...

2. vogenx.com vogenx.com/vogenx-announces-positive-results-in-second-phase-2-study-of-mizagliflozin-in-post-bariatric-hypoglycemia/

Vogenx Announces Positive Results From Second Phase 2 ... Mizagliflozin is effective in preventing hypoglycemic events without significantly impacting blood glucose levels in patients not experiencing hypoglycemia.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6474710/

Effect of Mizagliflozin on Postprandial Plasma Glucose in ... We reported that mizagliflozin showed favourable efficacy and safety for patients with functional constipation and the risk of hypoglycaemia would be low.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05541939?tab=results

Study Results | NCT05541939 | Effect of Mizagliflozin on ... The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.

5. finance.yahoo.com finance.yahoo.com/news/vogenx-announces-positive-results-second-190000294.html

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 ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2468125318301651

Safety and efficacy of the sodium-glucose cotransporter 1 ... No specific adverse events related to the mechanism of action of mizagliflozin, such as hypoglycaemia-like symptoms, were observed. According to Rome III and IV ...

7. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/39/NCT05541939/Prot_SAP_000.pdf

919.659.5677919.659.5677 To evaluate the safety, tolerability, and pharmacodynamics of two formulations of mizagliflozin with respect to postprandial plasma glucose ...

8. researchgate.net researchgate.net/publication/396795481_OR08-04_Efficacy_and_Safety_of_the_SGLT1_Inhibitor_Mizagliflozin_in_Patients_with_Post-Bariatric_Hypoglycemia

OR08-04 Efficacy and Safety of the SGLT1 Inhibitor ... Results Baseline frequency of hypoglycemic events, disability, and hypoglycemia-related worries were high. Symptom-triggered hypoglycemic events ...