A Phase 2 Study of Once-Weekly LY3437943 Compared With Placebo in Participants Who Have Obesity or Are Overweight With Weight-Related Comorbidities
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 338
- 试验地点
- 27
- 主要终点
- Mean Percent Change From Baseline in Body Weight
研究概览
简要总结
This is a study of LY3437943 in participants who have obesity or are overweight. The main purpose is to learn more about how LY3437943 affects body weight loss. The study will last about 18 months and may include up to 18 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)
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
- •Participants must have a Body Mass Index (BMI) ) ≥30 and ≤50 kilograms per square meter (kg/m²), or ≥27 kg/m² and <30 kg/m², with at least one of the following comorbidities: hypertension, dyslipidemia, cardiovascular disease
- •Participants must be willing to learn how to self-inject study drug or receive an injection from a trained individual if visually impaired or with physical limitations, and follow study procedures for the duration of the study, including, but not limited to, follow lifestyle advice (for example, dietary changes and physical activity plan), maintain a study drug administration log, and complete required questionnaires
排除标准
- •Participants must not have type 1 or type 2 diabetes mellitus
- •Participants must not have had an increase or decrease in body weight > more than 5 kg (11 pounds) within the past 3 months
- •Participants must not have had surgery for obesity or plan to have such surgery during the study
- •Participants must not be using medications that promote weight loss or cause weight gain
- •Participants must not drink excessive amounts of alcohol (more than 14 units a week for women or more than 21 units a week for men)
- •Participants must not have used marijuana within the last 3 months.
- •Participants must not have heart attack, stroke, or hospitalization for congestive heart failure in the past 3 months
- •Participants must not have active cancer within the last 5 years
- •Participants must not have uncontrolled high blood pressure
- •Participants must not have liver disease other than non-alcoholic fatty liver disease
- •Participants must not have renal impairment with estimated glomerular filtration rate (eGFR) <45 mL/min/1.73 m2
- •Participants must not have a history of acute or chronic pancreatitis symptomatic gallbladder disease or documented human immunodeficiency virus infection
- •Participants must not have a major problem with depression or other mental illness within the last 2 years
- •Participants must not have family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma (family is defined as a first degree relative)
- •Female participants must not be pregnant, breast-feeding, or intend to become pregnant or of childbearing potential and not using adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice)
研究组 & 干预措施
Placebo
Participants received placebo matched to LY3437943 administered as subcutaneous (SC) injection once-weekly (QW).
干预措施: Placebo (Drug)
1 milligram (mg) LY3437943
Participants received 1 mg LY3437943 administered as SC injection QW.
干预措施: LY3437943 (Drug)
4 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW.
干预措施: LY3437943 (Drug)
4 mg LY3437943
Participants received 4 mg LY3437943 administered as SC injection QW.
干预措施: LY3437943 (Drug)
8 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW.
干预措施: LY3437943 (Drug)
8 mg LY3437943 (4 mg)
Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as SC injection QW.
干预措施: LY3437943 (Drug)
12 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943, 8 mg LY3437943 and then 12 mg LY3437943 administered as SC injection QW.
干预措施: LY3437943 (Drug)
结局指标
主要结局
Mean Percent Change From Baseline in Body Weight
时间窗: Baseline, Week 24
Least squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) for post-baseline measures: Variable = Treatment\*Time + Baseline BMI (\< 36kg/m2 vs. \>=36 kg/m2)\*Time + Sex (Female vs. Male)\*Time + Baseline\*Time.
次要结局
- Percentage of Participants Who Achieve ≥ 10% Body Weight Reduction(Week 48)
- Mean Percent Change From Baseline in Body Weight(Baseline, Week 48)
- Percentage of Participants Who Achieve ≥ 5% Body Weight Reduction(Week 48)
- Percentage of Participants Who Achieve ≥ 15% Body Weight Reduction(Week 48)
- Mean Change From Baseline in Body Weight(Baseline, Week 48)
- Mean Change From Baseline in BMI(Baseline, Week 48)
- Mean Change From Baseline in Waist Circumference(Baseline, Week 48)