NCT07137585进行中（未招募）1 期
Effects of RO7204239 on Insulin Sensitivity, Muscle Composition and Function in Participants Living With Type 2 Diabetes Mellitus and Overweight or Obesity: A Double-blind, Randomized, Placebo-controlled Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change From Baseline in M-value in a Hyperinsulinemic Euglycemic Glucose Clamp (HEC) at Week 24
研究概览
简要总结
The main purpose of this study is to assess the effect of RO7204239 on insulin sensitivity versus placebo in participants with T2DM and obesity or overweight.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 治疗
- 盲法
- 四盲 (受试者、医护人员、研究者、结局评估者)
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 T2DM for at least 6 months, treated with diet, exercise and/or metformin alone or in combination with either dipeptidyl peptidase 4 (DPP-4) inhibitor or sodium-glucose co-transporter 2 (SGLT2) at stable dose for the last 3 months prior to study entry and with a HbA1c between ≤ 6.5% and ≤ 10%
- Body mass index (BMI) within the range of 27.0 to 45.0 kilogram per meter square (kg/m2)
- Stable body weight for the 3 months prior to screening
- Participants on lipid-lowering or antihypertensive drugs must be on stable doses for at least 3 months
排除标准
- Type 1 diabetes mellitus (DM), known latent autoimmune diabetes in adults, or people with an episode of ketoacidosis or hyperosmolar state requiring hospitalisation in 6 months prior to screening
- Active proliferative diabetic retinopathy, diabetic maculopathy, or severe non-proliferative diabetic retinopathy requiring acute treatment
- Uncontrolled comorbid conditions commonly associated with diabetes (for example, hypertension, hyperlipidaemia)
- Severe hypoglycaemia within 6 months prior to screening visit
- Current autonomic neuropathy as evidenced by neuropathic urinary retention, resting tachycardia, orthostatic hypotension, or diabetic diarrhea
- Have evidence of a significant, uncontrolled endocrine abnormality (e.g., thyrotoxicosis and adrenal crises)
- Are currently taking a central nervous system stimulant (e.g., Ritalin-SR), with the exception of caffeinated beverage
- Have a known allergy, hypersensitivity, or intolerance to any component of the study treatment (i.e., RO7204239 / placebo) formulation
- Blood donation of more than 500 milliliters (mL) within the past 3 months or blood transfusion or severe blood loss within 3 months prior to screening
研究组 & 干预措施
Placebo
Experimental
Participants will receive RO7204239 matching placebo, every 4 weeks (Q4W), as a subcutaneous (SC) injection for 24 weeks.
干预措施: Placebo (Drug)
RO7204239
Experimental
Participants will receive RO7204239, Q4W, as a SC injection for 24 weeks.
干预措施: RO7204239 (Drug)
结局指标
主要结局
Change From Baseline in M-value in a Hyperinsulinemic Euglycemic Glucose Clamp (HEC) at Week 24
时间窗: Baseline, Week 24
次要结局
- Number of Participants With Adverse Events (AEs)(Up to Week 48)
- Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12 and 24(Baseline, Week 12, Week 24)
- Change From Baseline in Glucose Metabolism Assessed Using Fasting Glucose Test at Weeks 12 and 24(Baseline, Week 12, Week 24)
- Change From Baseline in Glucose Metabolism Assessed Using Insulin Test at Weeks 12 and 24(Baseline, Week 12, Week 24)
- Change From Baseline in Glucose Metabolism Assessed Using C-peptide Test at Weeks 12 and 24(Baseline, Week 12, Week 24)
- Change From Baseline in Blood Lipid Profiles at Weeks 12 and 24(Baseline, Week 12, Week 24)
- Change From Baseline in Body Weight at Weeks 12 and 24(Baseline, Week 12, Week 24)
- Change From Baseline in Waist Circumference at Weeks 12 and 24(Baseline, Week 12, Week 24)
- Change From Baseline in Waist to Height Ratio at Weeks 12 and 24(Baseline, Week 12, Week 24)
- Change From Baseline in Total Lean Tissue Volume and Total Adipose Tissue Volume From Abdominal Magnetic Resonance Imaging (MRI) at Weeks 12 and 24(Baseline, Week 12, Week 24)
- Change From Baseline in Muscle Volume From Thigh Muscle MRI at Weeks 12 and 24(Baseline, Week 12, Week 24)
- Change From Baseline in Muscle Fat Infiltration From Thigh Muscle MRI at Weeks 12 and 24(Baseline, Week 12, Week 24)
- Number of Participants With Local and Systemic Injection Reactions(Up to Week 48)
研究者
研究点 (1)
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标识符
- NCT 编号
- NCT07137585
- 其他研究编号
- BP45980, 2025-521401-41-00, 2025
日期
- 首次提交
- (去年)
- 首次发布
- (去年)
- 主要完成日期
- (16天前)
- 研究完成日期
- (5个月后)
- 最近核实
- (29天前)
- 最近更新
- (昨天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否
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