Vogenx Initiates Phase 2b EMERGE Study of Mizagliflozin for Post-Bariatric Hypoglycemia
EMERGE will test two mizagliflozin doses against placebo, with combined Level 2 and Level 3 hypoglycemic events as its primary endpoint.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Summary
Vogenx (VOGX) has initiated EMERGE, a Phase 2b trial evaluating investigational mizagliflozin for low blood sugar following bariatric surgery.
The randomized, double-blind, placebo-controlled study plans to enroll approximately 36 adults. After a three-week run-in period, eligible participants will receive oral mizagliflozin 5 mg, 10 mg or placebo three times daily for 28 days. The primary endpoint is the number of combined Level 2 and Level 3 hypoglycemic events. Safety and tolerability will also be assessed, with continuous glucose monitoring during treatment. Vogenx expects approximately 10 U.S. sites.
Earlier clinical studies showed improvements in Level 2 and Level 3 hypoglycemic events in patients with post-bariatric hypoglycemia (PBH). Across clinical studies, no drug-related serious adverse events or discontinuations or withdrawals were reported. No FDA-approved therapy currently treats PBH.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Positive
- Moderate pointPhase 2b EMERGE initiated, advancing mizagliflozin's clinical development for post-bariatric hypoglycemia.
- Minor pointEarlier PBH studies showed improvements in Level 2 and Level 3 hypoglycemic events.
- Minor pointClinical safety experience included no drug-related serious adverse events and no discontinuations or withdrawals.
Negative
- None.
Key Figures
- Planned enrollment
- Approximately 36 participants
- EMERGE Phase 2b study
- Study treatment arms
- Mizagliflozin 5 mg, mizagliflozin 10 mg, or placebo
- Oral dosing
- Dosing frequency
- Three times daily
- EMERGE treatment regimen
- Treatment period
- 28 days
- After a three-week run-in period
- Planned study sites
- Approximately 10
- United States
- Prior clinical exposure
- More than 500 subjects across 10 clinical studies
- Mizagliflozin
Key Terms
post-bariatric hypoglycemia medical
placebo-controlled technical
double-blind technical
run-in period technical
sglt1 medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
RALEIGH, NC / ACCESS Newswire / October 15, 2026 / Vogenx, Inc. (NASDAQ:VOGX), a clinical-stage developer of novel therapeutics for the treatment of serious metabolic and gastrointestinal diseases, today announced the initiation of EMERGE (VGX-001-013), its Phase 2b clinical trial evaluating mizagliflozin for the treatment of post-bariatric hypoglycemia (PBH). There are currently no therapeutics approved by the U.S. Food and Drug Administration for the treatment of PBH.
EMERGE is a randomized, placebo-controlled, double-blind, parallel-group Phase 2b study designed to enroll approximately 36 adults who underwent bariatric surgery more than 12 months prior and who experience recurrent reactive hypoglycemia. Following a three-week run-in period, eligible participants will be randomized to receive mizagliflozin 5 mg, mizagliflozin 10 mg or placebo, taken orally three times daily for 28 days. The study will evaluate the safety and tolerability of mizagliflozin and its ability to reduce hypoglycemia, with glucose monitored continuously throughout treatment. Primary endpoint is the number of combined Level 2 and Level 3 hypoglycemic events. The trial is expected to be conducted at approximately 10 sites in the United States. Additional information is available at ClinicalTrials.gov under identifier NCT07760961.
"Initiating EMERGE is an important milestone for Vogenx and for people living with post-bariatric hypoglycemia, a serious and often debilitating condition with no approved treatment options," said James Green, Chief Executive Officer of Vogenx. "Mizagliflozin has been studied in more than 500 subjects across 10 clinical studies and has been shown to reduce Level 2 and Level 3 hypoglycemic events in clinical studies of patients diagnosed with PBH. EMERGE is designed to build on those earlier results in a larger, placebo-controlled parallel group setting, and we look forward to working with our investigators to advance enrollment."
"Patients with PBH can experience sudden, severe drops in blood sugar after meals that disrupt daily life and can be dangerous," said William Wilkison, PhD, Chief Scientific Officer. "By reducing and delaying glucose absorption in the small intestine, mizagliflozin targets key drivers of the exaggerated insulin response that causes these episodes. We are pleased to be underway with EMERGE."
About the EMERGE Study
EMERGE (VGX-001-013; NCT07760961) is a Phase 2b randomized, placebo-controlled, double-blind, repeat-dose, parallel-group study evaluating the safety, tolerability and effect on hypoglycemia of mizagliflozin in approximately 36 participants with post-bariatric hypoglycemia following bariatric surgery. After a run-in period, eligible participants will receive mizagliflozin 5 mg, mizagliflozin 10 mg or placebo three times daily for 28 days.
About Mizagliflozin
Mizagliflozin is an investigational, first-in-class, orally administered, minimally absorbed small molecule inhibitor of the sodium-dependent glucose transporter 1 (SGLT1). Unlike other SGLT inhibitors, which act systemically by blocking glucose reabsorption in the kidney, mizagliflozin is designed to act locally in the small intestine, with its effects limited to the intestinal lumen, where SGLT1 is the primary transporter responsible for dietary glucose absorption. By reducing and delaying intestinal glucose absorption, mizagliflozin lowers postprandial glucose absorption and reduces secretion of insulin and gastric inhibitory peptide, also known as glucose-dependent insulinotropic peptide (GIP). The molecule is being developed by Vogenx for the treatment of PBH, gastroparesis and GIP-dependent Cushing's Syndrome. Mizagliflozin has been administered to more than 500 subjects in 10 clinical studies and has shown statistically significant reductions in postprandial glucose absorption, GIP secretion, and insulin secretion. Mizagliflozin has also demonstrated improvement in postprandial glucose nadir as well as Level 2 and Level 3 hypoglycemia events in patients diagnosed with PBH. In clinical studies, mizagliflozin has been shown to be well tolerated with no drug-related serious adverse events and no discontinuations or withdrawals.
About Post-Bariatric Hypoglycemia
PBH is an increasingly recognized chronic side effect of bariatric surgeries that are commonly performed as a treatment for obesity and related comorbidities. Neuroglycopenic symptoms can include shakiness, dizziness, confusion, sweating and loss of consciousness. These symptoms can significantly impair quality of life, disrupt normal day-to-day activities and can be life-threatening. Following bariatric surgeries, patients often overexpress SGLT1 in the intestinal lumen, which increases the quantity and rate of glucose absorption and leads to increases in the secretion of GIP and insulin. There are currently no therapeutics approved by the U.S. Food and Drug Administration for the treatment of PBH.
About Vogenx, Inc.
Vogenx, Inc. (NASDAQ:VOGX) is a clinical-stage biopharmaceutical company based in Raleigh, North Carolina, focused on the discovery and development of novel therapeutics for the treatment of serious metabolic and gastrointestinal diseases with high unmet medical need. The Company is developing its lead product candidate, mizagliflozin, for post-bariatric hypoglycemia, gastroparesis and GIP-dependent Cushing's Syndrome. For more information, please visit https://vogenx.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the design, conduct, enrollment, timing and results of the EMERGE Phase 2b study, including the expected timing of topline data; the potential of mizagliflozin to treat post-bariatric hypoglycemia and other indications; anticipated clinical development plans and timelines; the anticipated use of proceeds from the Company's initial public offering; and the potential market opportunity for its product candidates. Words such as "anticipate," "believe," "expect," "intend," "plan," "potential," "will" and similar expressions are intended to identify forward-looking statements. These statements are based on management's current expectations and are subject to risks and uncertainties that could cause actual results to differ materially, including risks related to the initiation, timing, enrollment and results of clinical trials, the possibility that results of earlier studies may not be predictive of later studies, regulatory review, reliance on third parties including clinical research organizations and clinical trial sites, the Company's license from Kissei Pharmaceutical Co., Ltd., the Company's need for additional capital, its limited operating history, and its dependence on a small number of key personnel. Additional information on these and other risks is contained in the Company's filings with the Securities and Exchange Commission, including the prospectus filed pursuant to Rule 424(b)(4) on August 12, 2026. Forward-looking statements speak only as of the date of this release, and Vogenx undertakes no obligation to update them except as required by law.
Contact
Harrison Seidner, PhD and Nilesh Talele, PhD
WaterSeid Partners, Inc.
ir@vogenx.com
SOURCE: Vogenx, Inc.
View the original press release on ACCESS Newswire
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What is Vogenx testing in the Phase 2b EMERGE trial?
EMERGE evaluates mizagliflozin's safety, tolerability and effect on hypoglycemia in approximately 36 adults with post-bariatric hypoglycemia. Participants will receive 5 mg, 10 mg or placebo orally three times daily for 28 days after a three-week run-in period. The primary endpoint counts combined Level 2 and Level 3 hypoglycemic events.
Who is eligible for Vogenx's EMERGE study, and where is it registered?
EMERGE is designed to enroll adults who underwent bariatric surgery more than 12 months prior and experience recurrent reactive hypoglycemia. Additional study information is available on ClinicalTrials.gov under identifier NCT07760961.