EUCTR2021-002805-88-HU进行中（未招募）1 期
A Phase 2 Study of Once-Daily LY3502970 Compared with Placebo in Participants Who Have Obesity or Are Overweight with Weight-Related Comorbidities
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 270
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Have a body mass index (BMI) of =30-kilogram per square meter (kg/m²)
- •=27 kg/m² and <30 kg/m² with at least 1 of the following weight-related comorbidities
- •Have hypertension, or dyslipidemia
- •Have cardiovascular disease: (for example, ischemic cardiovascular disease
- •Have obstructive sleep apnea (only in participants >30 years of age)
- •Have had a stable body weight for the 3 months prior to randomization (5% body weight gain and/or loss)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 216
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 54
排除标准
- •Have any prior diagnosis of Type 1 diabetes mellitus
- •Have a prior 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)
- •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.
- •Have poorly controlled hypertension
- •Have any acute myocardial infarction
- •Have cerebrovascular accident (stroke)
- •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
研究者
相似试验
进行中（未招募）
1 期
Effect of LY3502970 Versus Placebo and Dulaglutide in Participants with Type 2 Diabetes MellitusType 2 diabetes mellitusMedDRA version: 21.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861EUCTR2021-002806-29-HUEli Lilly and Company370
进行中（未招募）
1 期
Effect of LY3502970 Versus Placebo and Dulaglutide in Participants with Type 2 Diabetes MellitusType 2 diabetes mellitusMedDRA version: 21.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861EUCTR2021-002806-29-SKEli Lilly and Company370
进行中（未招募）
1 期
Effect of LY3502970 Versus Placebo and Dulaglutide in Participants with Type 2 Diabetes MellitusEUCTR2021-002806-29-PLEli Lilly and Company383
进行中（未招募）
1 期
A clinical trial comparing the effects of experimental drug versus placebo and an approved drug in once-weekly dosing for patients diagnosed with Type 2 Diabetes Mellitus.Diabetes Mellitus, Type 2MedDRA version: 21.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861EUCTR2016-004179-33-PLEli Lilly and Company316
进行中（未招募）
1 期
A clinical trial comparing the effects of experimental drug versus placebo and an approved drug in once-weekly dosing for patients diagnosed with Type 2 Diabetes Mellitus.Diabetes Mellitus, Type 2MedDRA version: 20.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861EUCTR2016-004179-33-SKEli Lilly and Company316