A Phase 2a, Open-label, Exploratory Study to Evaluate Preliminary Efficacy of Subcutaneous MBX 1416 in Patients With Postbariatric Hypoglycemia (The STEADI Study)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 5
- 主要终点
- Changes from baseline to post-treatment in glucose nadir during a standardized MMTT following different dose levels of MBX 1416.
研究概览
简要总结
The purpose of this study is to assess the preliminary efficacy of single SC administration of MBX 1416 at different dose levels in patients with PBH
详细描述
This is a Phase 2a, open-label, exploratory study to evaluate preliminary efficacy of SC MBX 1416 in patients with PBH. Approximately 20 patients aged 18 to 75 (inclusive) years with history of hypoglycemia following Roux-en-Y or sleeve gastrectomy will be included in the study. Participants will undergo 3 mixed-meal tolerance tests, one at baseline and again 48 hours after each MBX 1416 administration, to evaluate the effect of MBX 1416 on increasing post-prandial glucose nadir. MBX 1416 effect in reducing post-prandial insulin and C-peptide peaks will also be evaluated
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant must be ≥18 to ≤75 years of age at the time of signing the informed consent.
- •Participants must have undergone RYGB or SG surgery at least 12 months prior to study entry.
- •Participants should have a documented history of PBH, defined as Whipple's triad (symptomatic hypoglycemia, capillary glucose ≤54 mg/dL, with symptom resolution by carbohydrate administration) and a minimum of 1 symptomatic hypoglycemic episode per month by patient report.
- •Participants who are either treatment naïve or who are no longer using (i.e., have discontinued as part of their usual medical care) agents known to interfere with glucose metabolism at the time of screening.
- •Participants must have a body mass index (BMI) <45 kg/m2 at screening.
- •Must have signed informed consent.
排除标准
- •History of, or currently active, significant illness or medical disorders that in the opinion of the investigator may preclude participants from participating in the study.
- •Currently on-going type II diabetes mellitus.
- •History of hypoglycemia prior to bariatric surgery.
- •History of insulinoma or other endogenous hyperinsulinemia illness (e.g., congenital hyperinsulinism).
研究组 & 干预措施
MBX 1416 (INN imapextide)
Single subcutaneous administration at different dose levels
干预措施: MBX 1416 (INN imapextide) (Drug)
结局指标
主要结局
Changes from baseline to post-treatment in glucose nadir during a standardized MMTT following different dose levels of MBX 1416.
时间窗: The duration of the study will be approximately 67 days from screening to end of study (EoS) for any given participant
次要结局
未报告次要终点