A Phase 1, Investigator- and Participant- Blinded, Randomized, Placebo-Controlled, Single-Dose Study to Investigate the Impact of Tirzepatide on Gastric Emptying in Adult Participants With Type 1 Diabetes Mellitus and Overweight or Obesity
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Pharmacokinetics (PK): Time of Maximum Observed Drug Concentration (Tmax) of Acetaminophen
研究概览
简要总结
The main purpose of this study is to learn more how tirzepatide affects stomach emptying in participants with Type 1 Diabetes Mellitus (T1DM) and overweight or obesity.
Participation in this study will last about 8 weeks, including screening and follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a diagnosis of type 1 diabetes mellitus (T1DM) and have been treated with insulin for at least 1 year prior to screening
- •Have a body mass index (BMI) greater than or equal to 25.0 kilograms per square meter (kg/m2) at screening
- •Are of stable weight, that is a self-reported change of 5 kg or less, for at least 90 days prior to screening
排除标准
- •Participants who have a known clinically significant gastric emptying abnormality
- •Have undergone weight loss surgery such as gastric bypass (bariatric) surgery or restrictive bariatric surgery
- •Have known allergies or intolerance to acetaminophen, tirzepatide, or glucagon-like peptide-1 (GLP-1) receptor agonists
研究组 & 干预措施
Placebo + Acetaminophen
Participants will receive placebo administered SC and acetaminophen administered orally.
干预措施: Placebo (Drug)
Placebo + Acetaminophen
Participants will receive placebo administered SC and acetaminophen administered orally.
干预措施: Acetaminophen (Drug)
Tirzepatide + Acetaminophen
Participants will receive tirzepatide administered subcutaneously (SC) and acetaminophen administered orally.
干预措施: Tirzepatide (Drug)
Tirzepatide + Acetaminophen
Participants will receive tirzepatide administered subcutaneously (SC) and acetaminophen administered orally.
干预措施: Acetaminophen (Drug)
结局指标
主要结局
Pharmacokinetics (PK): Time of Maximum Observed Drug Concentration (Tmax) of Acetaminophen
时间窗: Predose on Day 1 through 36 hours post dose
PK: Area Under the Concentration Versus Time Curve from Time Zero to Time t (AUC0-tlast) of Acetaminophen
时间窗: Predose on Day 1 through 36 hours post dose
PK: Maximum Observed Drug Concentration (Cmax) of Acetaminophen
时间窗: Predose on Day 1 through 36 hours post dose
次要结局
- PK: Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC0-∞) of Tirzepatide(Predose on Day 1 through Day 29)
- PK: Area Under the Concentration Versus Time Curve from Time Zero to Time t (AUC0-tlast) of Tirzepatide(Predose on Day 1 through Day 29)
- PK: Maximum Observed Drug Concentration (Cmax) of Tirzepatide(Predose on Day 1 through Day 29)
- PK: Time of Maximum Observed Drug Concentration (Tmax) of Tirzepatide(Predose on Day 1 through Day 29)