NCT06313528已完成1 期
A Randomized, Double-Blind, Phase 1 Study to Investigate the Effect of LY3437943 Versus Placebo on Calorie Intake and Energy Expenditure in Participants With Obesity Under Calorie Restriction
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
- 85
- 试验地点
- 3
- 主要终点
- Change from Baseline in Total Calorie Intake at Lunch and Dinner (Combined)
研究概览
简要总结
The main purpose of the study is to look at the effect of the study drug compared to placebo on calorie intake, energy metabolism, and appetite. The study will last up to 6 months and may include up to 20 visits.
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
- Double (Participant, Investigator)
盲法说明
Sponsor-blind
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
- •BMI greater than 30 kg/m2
- •History of at least 1 self-reported unsuccessful dietary effort to reduce body weight
排除标准
- •Change in body weight of greater than 5 kg (11 pounds) within 3 months prior to start of study
- •Any of the following treatments for obesity within 1 year prior, or plan to undergo any of these during the study period: liposuction, cryolipolysis, or abdominoplasty
- •Prior or planned bariatric or gastric sleeve surgery, endoscopic therapy, or device-based therapy for obesity
- •Type 1 or Type 2 Diabetes, history of ketoacidosis, or hyperosmolar state
- •Family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome Type 2
- •Acute or chronic hepatitis
- •Had within 90 days prior: acute myocardial infarction, cerebrovascular accident (stroke), coronary artery revascularization, hospitalization for unstable angina, or hospitalization due to congestive heart failure
- •History of active or unstable major depressive disorder or other severe psychiatric disorder within 2 years prior
- •History of chronic or acute pancreatitis
- •Blood transfusion or severe blood loss within the last 3 months or hemoglobinopathy, hemolytic anemia, sickle cell anemia
- •Clinically significant multiple or severe drug allergies
- •Started treatment with or changed dose within 12 months prior any medications that are associated with significant weight gain
- •History of substance use disorder
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo administered SC
干预措施: Placebo (Other)
LY3437943
Experimental
LY3437943 administered subcutaneously (SC)
干预措施: LY3437943 (Drug)
结局指标
主要结局
Change from Baseline in Total Calorie Intake at Lunch and Dinner (Combined)
时间窗: Baseline up to Week 17 (inclusive)
次要结局
- Change from Baseline in Sleep Metabolic Rate (SMR)(Baseline up to Week 16 (inclusive))
- Change from Baseline in SMR(Baseline up to Week 16 (inclusive))
- Change from Baseline in 24-hour Energy Expenditure (EE)(Baseline up to Week 16 (inclusive))
- Change from Baseline in 24-hour EE(Baseline up to Week 16 (inclusive))
- Change from Baseline in Total Calorie Intake at Lunch(Baseline up to Week 17 (inclusive))
- Change from Baseline in Total Calorie Intake at Dinner(Baseline up to Week 17 (inclusive))
- Change from Baseline in Fasting Appetite Visual Analog Score (VAS)(Baseline up to Week 16 (inclusive))
研究者
研究点 (3)
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