NCT07760961尚未招募2 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- Vogenx, Inc.
- 入组人数
- 36
- 主要终点
- Number of combined Level 2 (as measured by self-monitored blood glucose) and Level 3 hypoglycemic events (as measured by diary entry and adjudicated)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Sponsor
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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, 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.
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Mizagliflozin 5mg
Experimental
干预措施: Mizagliflozin 5 mg (Drug)
Mizagliflozin 10mg
Experimental
干预措施: Mizagliflozin 10 mg (Drug)
结局指标
主要结局
Number of combined Level 2 (as measured by self-monitored blood glucose) and Level 3 hypoglycemic events (as measured by diary entry and adjudicated)
时间窗: During the double-blind treatment period (approximately 28 days)
次要结局
未报告次要终点
研究者
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