NCT04081337已完成1 期
A Randomized, Placebo-Controlled, Parallel-Arm Study to Investigate the Effect of Once-Weekly Tirzepatide on Energy Expenditure and Food Intake in Obese Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Change From Baseline to Week 18 in Sleep Metabolic Rate (SMR)
研究概览
简要总结
This is a study of tirzepatide in participants with obesity. The main purpose is to learn more about how tirzepatide affects the number of calories participants burn and the amount of food they eat. The study lasted for 28 weeks and will include about 21 visits to the study center.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have body mass index of 30 to 45 kilograms per square meter (kg/m²), inclusive
- •Have a stable body weight in the past 1 month prior to screening
- •Willing and agreeable to commit to the duration of the study and undergo study procedures as instructed by the clinic staff
排除标准
- •Have undergone gastric bypass or bariatric surgery
- •Have a diagnosis of type 2 diabetes
- •Have a history or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological or neurological disorders capable of significantly altering the absorption, metabolism or elimination of drugs; of constituting a risk when taking the study drug; or of interfering with the interpretation of data
- •Have received prescription drugs or over the counter drugs that promote weight loss in the past 6 months prior to screening
- •Have any lifetime history of a suicide attempt
- •Patient Health Questionnaire-9 (PHQ-9) score of 15 or more at screening
- •Positive responses to selected items on the Columbia Suicide Severity Rating Scale (C-SSRS)
研究组 & 干预措施
Placebo
Placebo Comparator
Participants received placebo once weekly (QW) by Subcutaneous (SC) injection.
干预措施: Placebo (Drug)
15 Milligram (mg) Tirzepatide
Experimental
Participants received 15 mg of tirzepatide QW by SC injection.
干预措施: Tirzepatide (Drug)
结局指标
主要结局
Change From Baseline to Week 18 in Sleep Metabolic Rate (SMR)
时间窗: Baseline, Week 18
SMR was measured using whole-room indirect calorimetry (respiratory chamber). Change from Baseline to Week 18 in SMR was evaluated. Least square (LS) mean was determined by analysis of covariance (ANCOVA) model with Baseline, Treatment, Change from Baseline to Week 18 in Fat-Free Mass, Change from baseline to Week 18 in Fat Mass and Random Error as variables.
次要结局
- Change From Baseline to Week 18 in 24 Hour Respiratory Quotient (RQ)(Baseline, Week 18)
- Change From Baseline to Week 18 in Body Fat Mass(Baseline, Week 18)
- Change From Baseline to Week 18 in Fasting Insulin Resistance(Baseline, Week 18 during standardized mixed meal tolerance test)
- Change From Baseline to Week 18 in Hemoglobin A1c (HbA1c)(Baseline, Week 18)
- Change From Baseline to Week 18 in Body Weight (BW)(Baseline, Week 18)
- Change From Baseline to Week 18 in Sleep RQ(Baseline, Week 18)
- Change From Baseline to Week 18 in Duration of Periods With RQ<0.80(Baseline, Week 18)
- Change From Baseline to Week 18 in Postprandial Insulin Sensitivity(Baseline, Week 18)
- Change From Baseline to Week 18 in Food Intake During Ad Libitum Meal(Baseline, Week 18)
- Change From Baseline to Week 18 in 24-hour Energy Expenditure (EE)(Baseline, Week 18)
- Change From Baseline to Week 18 in Percentage of Body Fat Mass(Baseline, Week 18)
- Change From Baseline to Week 18 in Fat, Protein, and Carbohydrate Oxidation(Baseline, Week 18)
- Change From Baseline to Week 18 in Body Fat-Free Mass(Baseline, Week 18)
- Change From Baseline to Week 18 in Lipid Metabolism Parameters(Baseline, Week 18)
- Change From Baseline to Week 18 in Postmeal Total Glucose AUC During sMMTT(Baseline, Week 18)
研究者
研究点 (1)
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