A Phase 2, Multicenter, Randomized, Single-Blind, Placebo-Controlled Cross-over Study to Assess the Efficacy and Safety of Exendin 9-39 in Patients With Postbariatric Hypoglycemia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 5
- 主要终点
- Postprandial Glucose Nadir
研究概览
简要总结
This clinical study will evaluate whether taking an investigational drug called exendin 9-39 is safe, well-tolerated, and helps to prevent low blood sugar in people who have had bariatric surgery and later develop a rare condition called postbariatric hypoglycemia (PBH).
详细描述
This is a Phase 2, multicenter, randomized, single-blind, placebo-controlled cross-over study in patients with refractory PBH.
Participants will be randomized and assigned in a 1:1 ratio to one of two treatment arms. All participants will receive 2 dosing regimens of exendin 9-39 and matching placebo self-administered via subcutaneous (SC) injection.
Participants will undergo in-clinic mixed meal tolerance test (MMTT) provocation with concomitant blood draws and symptom assessments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body mass index (BMI) of up to 40 kg/m2
- •Roux-en-Y gastric bypass (RYGB) surgery performed ≥12 months prior
- •Diagnosis of PBH
- •At least 2 episodes during screening 2-week run-in phase of severe hypoglycemia
排除标准
- •Other cause of endogenous hyperinsulinism other than PBH
- •Metabolic or bariatric surgical procedure other than RYGB
- •History of non-RYGB upper GI surgery
- •Use of agents that may interfere with glucose metabolism
研究组 & 干预措施
Treatment Group 1
patients will receive two dose regimens of exendin 9-39 and one placebo
干预措施: exendin 9-39 (Drug)
Treatment Group 1
patients will receive two dose regimens of exendin 9-39 and one placebo
干预措施: Placebo (Other)
Treatment Group 2
patients will receive two dose regimens of exendin 9-39 and one placebo (in a different sequence than Treatment Group 1)
干预措施: exendin 9-39 (Drug)
Treatment Group 2
patients will receive two dose regimens of exendin 9-39 and one placebo (in a different sequence than Treatment Group 1)
干预措施: Placebo (Other)
结局指标
主要结局
Postprandial Glucose Nadir
时间窗: 3 hours following a liquid meal
Plasma glucose nadir occurring within 3 hours of mixed-meal tolerance testing (MMTT)
次要结局
未报告次要终点