NCT05931380已完成3 期
A Phase 3, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Once-Daily Oral LY3502970 Compared With Placebo in Japanese Adult Participants With Obesity Disease
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 238
- 试验地点
- 29
- 主要终点
- Mean Percent Change in Body Weight
研究概览
简要总结
The main purpose of this study is to investigate the efficacy and safety of oral orforglipron in participants with obesity disease with obesity-related health problems.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with a BMI ≥27 kg/m² and <35 kg/m² and at least 2 obesity-related health problems (treated or untreated), OR a BMI ≥35 kg/m² and at least 1 obesity-related health problem (treated or untreated). At least one obesity-related health problem should be hypertension, dyslipidemia or T2D (approximately 25% of participants).
- •Have a history of at least one self-reported unsuccessful dietary effort to lose body weight.
- •Males and females may participate in this trial. Female participants must not be pregnant, intending to be pregnant, breastfeeding, or intending to breastfeed.
- •Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- •No male contraception is required except in compliance with specific local government study requirements.
排除标准
- •For participants with Type 2 Diabetes (T2D):
- •Have Type 1 Diabetes (T1D), history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except T2D.
- •Have had 1 or more episode of severe hypoglycemia and/or 1 or more episode of hypoglycemia unawareness within the 180 days prior to screening.
- •Have renal impairment measured as estimated glomerular filtration rate (eGFR) <15 mL/min/1.73 m², calculated by Japanese Society of Nephrology coefficient-modified chronic kidney disease-epidemiology equation during screening.
- •Have a known clinically significant gastric emptying abnormality.
- •For participants without Type 2 diabetes (T2D): Have any type of diabetes with hemoglobin A1c (HbA1c) ≥6.5 %.
- •Have a self-reported change in body weight >5 kg (11 pounds) within 90 days prior to screening.
- •Have chronic kidney disease.
- •Have lupus or rheumatoid arthritis.
- •Have the following cardiovascular conditions within 90 days prior to screening.
- •Have acute or chronic hepatitis.
结局指标
主要结局
Mean Percent Change in Body Weight
时间窗: Baseline, Week 72
Percentage of Participants Who Achieve ≥5% Body Weight Reduction
时间窗: Baseline to Week 72
Percent Change From Baseline in Body Weight at Week 72
时间窗: Baseline, Week 72
Values reported as "LS Mean" are model-based estimates (MBE) of the adjusted (unconditional) treatment effect. MBEs was calculated using an analysis of covariance (ANCOVA) model with the following variables: treatment group, baseline value, baseline Body Mass Index (BMI) category (\<35 kilogram per meter square \[kg/m²\] or ≥35 kg/m²), and stratification factors (sex and baseline type 2 diabetes status). Strata were defined by joint levels of sex (female, male) and baseline type 2 diabetes status (yes, no).
Percentage of Participants Who Achieved With Greater Than or Equal to (≥) 5% Body Weight Reduction From Baseline
时间窗: Baseline to Week 72
Percentage of participants with ≥5% body weight reduction was analysed by Logistic regression with the following variables: treatment group, baseline value, baseline BMI category (\<35 kg/m² or ≥35 kg/m²), and stratification factors (sex and baseline type 2 diabetes status). Stratification factors were defined by the combination of sex (female, male) and baseline type 2 diabetes status (yes, no). The model also allowed the treatment effect to vary across baseline values and stratification factors.
次要结局
- Percentage of Participants Who Achieve ≥10% Body Weight Reduction(Baseline to Week 72)
- Percentage of Participants Who Achieve ≥15% Body Weight Reduction(Baseline to Week 72)
- Percentage of Participants Who Achieve ≥20% Body Weight Reduction(Baseline to Week 72)
- Mean Change from Baseline in Body Mass Index (BMI)(Baseline, Week 72)
- Percentage of Participants Who Had Improvements in Dyslipidemia (only for participants with Dyslipidemia at baseline)(Baseline to Week 72)
- Percentage of Participants Who Achieve HbA1c Target value (<6.5% (48 mmol/mol) at Week 72 (only T2D at Baseline):(Baseline to Week 72)
- Mean Change from Baseline in Visceral Adipose Tissue (VAT)(Baseline, Week 72)
- Mean Change from Baseline in Waist Circumference at Umbilical Level(Baseline, Week 72)
- Mean Change from Baseline in Systolic Blood Pressure (SBP)(Baseline, Week 72)
- Mean Change from Baseline in non-High Density Lipoprotein (HDL)(Baseline, Week 72)
- Mean Change from Baseline in HDL(Baseline, Week 72)
- Mean Change from Baseline in Triglycerides(Baseline, Week 72)
- Mean Change from Baseline in Fasting Glucose(Baseline, Week 72)
- Mean Change from Baseline in Hemoglobin A1c (HbA1c)(Baseline, Week 72)
- Mean Change from Baseline in High-sensitivity C-reactive Protein(Baseline, Week 72)
- Mean Change from Baseline in Short Form 36 Version 2 (SF-36v2) Acute Form Domain Scores(Baseline, Week 72)
- Mean Change from Baseline in IMPACT of Weight on Quality-of-Life Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function, Physical, and Psychosocial Composite Score(Baseline, Week 72)
- Time to Onset of Type 2 Diabetes (T2D) (only non T2D at Baseline)(Baseline to Week 72)
- Pharmacokinetics (PK): Plasma Concentration of Orforglipron(Baseline to Week 72)
- Percentage of Participants Who Had Improvements in Hypertension(Baseline to Week 72)
- Pharmacokinetics (PK): Mean Plasma Concentration of Orforglipron(Pre-dose at Weeks 8, 24, and 48; post-dose at Week 16 (4 to 12 hours) and Week 36 (1 to 4 hours))
- Percentage of Participants Who Achieved ≥10% Body Weight Reduction From Baseline(Baseline to Week 72)
- Percentage of Participants Who Achieved ≥15% Body Weight Reduction From Baseline(Baseline to Week 72)
- Percentage of Participants Who Achieved ≥20% Body Weight Reduction From Baseline(Baseline to Week 72)
- Change From Baseline in Body Mass Index (BMI) at Week 72(Baseline, Week 72)
- Percentage of Participants Who Had Improvements in Dyslipidemia(Baseline to Week 72)
- Percentage of Participants Who Achieve Hemoglobin A1c (HbA1c) Target Value (<6.5% [48 mmol/Mol])(Baseline to Week 72)
- Mean Change From Baseline in Visceral Adipose Tissue (VAT) at Week 72(Baseline, Week 72)
- Mean Change From Baseline in Waist Circumference at Umbilical Level at Week 72(Baseline, Week 72)
- Mean Change From Baseline in Systolic Blood Pressure (SBP) at Week 72(Baseline, Week 72)
- Percent Change From Baseline in Non-High Density Lipoprotein (Non-HDL) at Week 72(Baseline, Week 72)
- Percent Change From Baseline in High Density Lipoprotein (HDL) at Week 72(Baseline, Week 72)
- Percent Change From Baseline in Triglycerides at Week 72(Baseline, Week 72)
- Mean Change From Baseline in Fasting Glucose at Week 72(Baseline, Week 72)
- Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 72(Baseline, Week 72)
- Mean Change From Baseline in High-sensitivity C-reactive Protein at Week 72(Baseline, Week 72)
- Time to Onset of Type 2 Diabetes (T2D)(Up to Week 72)
- Mean Change From Baseline in Short Form 36 Version 2 (SF-36v2) Acute Form For Domain and Component Scores at Week 72(Baseline, Week 72)
- Mean Change From Baseline in Impact of Weight on Quality-of-Life Lite Clinical Trials Version (IWQOL-Lite-CT) of Physical Function, Physical, and Psychosocial Composite Score at Week 72(Baseline, Week 72)
研究者
研究点 (29)
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