A Phase 2 Study of Once-Daily LY3502970 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
- 272
- 试验地点
- 35
- 主要终点
- Percent Change From Baseline in Body Weight in LY3502970 and Placebo
研究概览
简要总结
The main purpose of the study was to assess the effect of LY3502970 in participants who have obesity or are overweight.
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
- •Have a body mass index (BMI) of ≥30-kilogram square meter (kg/m²)
- •Have a BMI ≥27 kg/m² and <30 kg/m² with at least 1 of the following weight-related comorbidities eg; [Have hypertension, or dyslipidemia, cardiovascular disease]
- •Have had a stable body weight for the 3 months prior to randomization (not more than 5% body weight gain and/or loss)
排除标准
- •Have any prior diagnosis of diabetes
- •Have a prior or planned surgical treatment for obesity
- •Have obesity induced by other endocrinological disorders or diagnosed monogenetic or syndromic forms of obesity
- •Have renal impairment measured as estimated glomerular filtration rate (eGFR) <30 milliliter (mL)/minute (min)/1.73 m²
- •Have a history of acute chronic pancreatitis
- •Have a history of significant active or unstable Major Depressive Disorder (MDD) or other severe psychiatric disorder (for example, schizophrenia, bipolar disorder, or other serious mood or anxiety disorder) within the last 2 years Note: Participants with MDD or generalized anxiety disorder whose disease state is considered stable for the past 2 years and expected to remain stable throughout the course of the study, may be considered for inclusion if they are not on excluded medications.
- •Within 3 months prior to screening:
- •Have poorly controlled hypertension
- •Have history of acute myocardial infarction
- •Have history of cerebrovascular accident (stroke)
- •Had hospitalization due to congestive heart failure (CHF)
- •Have cancer
- •Have human immunodeficiency virus (HIV) and/or positive HIV antibodies historically or at screening
- •Have hepatitis B and/or positive hepatitis B surface antigen
研究组 & 干预措施
45 mg-1 LY3502970
Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally once daily until 36 weeks.
干预措施: LY3502970 (Drug)
12 milligram (mg) LY3502970
Participants received maintenance dose 12 mg with dose escalation starting from 3 mg,6 mg and then 12 mg LY3502970 administered orally once daily until 36 weeks.
干预措施: LY3502970 (Drug)
24 mg LY3502970
Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally once daily until 36 weeks.
干预措施: LY3502970 (Drug)
36 mg-1 LY3502970
Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 administered orally once daily until 36 weeks.
干预措施: LY3502970 (Drug)
36 mg-2 LY3502970
Participants received maintenance dose 36 mg with dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 administered orally once daily until 36 weeks.
干预措施: LY3502970 (Drug)
45 mg-2 LY3502970
Participants received maintenance dose 45 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally once daily until 36 weeks.
干预措施: LY3502970 (Drug)
Placebo
Participants received placebo administered orally once daily until 36 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Percent Change From Baseline in Body Weight in LY3502970 and Placebo
时间窗: Baseline, Week 26
Least Squares (LS) mean was determined by mixed model repeated measures (MMRM) model with Baseline + Baseline BMI Group + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Percent Change from Baseline) = Unstructured.
次要结局
- Change From Baseline in Body Weight in LY3502970 and Placebo(Baseline, Week 36)
- Change From Baseline in Waist Circumference in LY3502970 and Placebo(Baseline, Week 36)
- Change From Baseline in BMI in LY3502970 and Placebo(Baseline, Week 36)
- Percentage of Participants With >=5% Body Weight Loss(Week 36)
- Percentage of Participants With >=10% Body Weight Loss(Week 36)
- Percent Change From Baseline in Body Weight in LY3502970 and Placebo(Baseline, Week 36)