NCT07112872进行中（未招募）2 期
A Randomized, Double-Blind, Placebo- and Open-Label Active Comparator- Controlled, Parallel-Group, Multi-Center Phase II Study to Evaluate the Efficacy, Safety, and Tolerability of Once-Daily RO7795081 Administered for 30 Weeks to Participants With Type 2 Diabetes Mellitus
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 240
- 试验地点
- 95
- 主要终点
- RO7795081 vs. Placebo: Change in Glycated Hemoglobin (HbA1c) from Baseline at Week 30
研究概览
简要总结
This multicenter, randomized, double-blind, placebo- and open-label active comparator-controlled, parallel-group, dose-range-finding, Phase II study aims to evaluate the efficacy, tolerability, and safety of RO7795081 for glycemic control in adult participants with Type 2 diabetes mellitus (T2D).
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
- •Have a diagnosis of Type 2 diabetes mellitus (T2D) for at least 6 months before screening
- •Have an HbA1c ≥7% and ≤10.5% at screening
- •Management of T2D with diet and exercise alone or with either a stable dose of metformin or/and sodium-glucose cotransporter-2 (SGLT-2) inhibitors
- •Body mass index (BMI) ≥23.0 kg/m^2 at screening
- •A stable body weight within 3 months prior to screening (maximum 5% self-reported body weight gain and/or loss)
排除标准
- •Have Type 1 diabetes (T1D), history of ketosis or hyperosmolar state/coma, or any other types of diabetes except T2D
- •Have had 1 or more episodes of Level 3 hypoglycemia or has hypoglycemia unawareness within the 6 months prior to screening
- •History or presence of proliferative diabetic retinopathy, diabetic macular edema, or non-proliferative diabetic retinopathy that requires acute treatment
- •Evidence of clinically significant/active nephropathy or neuropathy (including resting tachycardia, orthostatic hypotension, and diabetic diarrhea)
- •Current treatment or treatment within 3 months of screening with any other anti-hyperglycemic medication except metformin or SGLT-2 inhibitors
- •Have obesity induced by other endocrinologic disorders (e.g., Cushing's syndrome) or diagnosed monogenetic or syndromic forms of obesity (e.g., melanocortin-4 receptor deficiency or Prader-Willi Syndrome)
- •Have a known, clinically significant gastric emptying abnormality
- •Have poorly controlled hypertension at screening, untreated renal artery stenosis, or evidence of labile blood pressure including symptomatic postural hypotension
- •Have any of the following cardiovascular conditions within 3 months prior to screening: Acute myocardial infarction; Cerebrovascular accident (stroke)/transient ischemic attack; Unstable angina; Hospitalization due to congestive heart failure
研究组 & 干预措施
Arm 5: RO7795081 Dosing Regimen 3
Experimental
干预措施: RO7795081 (Drug)
Arm 6: RO7795081 Dosing Regimen 4
Experimental
干预措施: RO7795081 (Drug)
Arm 7: RO7795081 Dosing Regimen 5
Experimental
干预措施: RO7795081 (Drug)
Arm 1: Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Arm 2: Semaglutide 14 mg
Active Comparator
干预措施: Semaglutide (Drug)
Arm 3: RO7795081 Dosing Regimen 1
Experimental
干预措施: RO7795081 (Drug)
Arm 4: RO7795081 Dosing Regimen 2
Experimental
干预措施: RO7795081 (Drug)
Arm 8: RO7795081 Dosing Regimen 6
Experimental
干预措施: RO7795081 (Drug)
Arm 9: RO7795081 Dosing Regimen 7
Experimental
干预措施: RO7795081 (Drug)
结局指标
主要结局
RO7795081 vs. Placebo: Change in Glycated Hemoglobin (HbA1c) from Baseline at Week 30
时间窗: Baseline to Week 30
次要结局
- RO7795081 vs. Semaglutide: Change in HbA1c from Baseline at Week 30(Baseline to Week 30)
- Percentage of Participants with HbA1c <5.7%, ≤6.5%, and <7.0% at Week 30(Week 30)
- Change in Fasting Plasma Glucose from Baseline at Week 30(Baseline to Week 30)
- Percent Change in Body Weight from Baseline at Week 30(Baseline to Week 30)
- Absolute Change in Body Weight (kg) from Baseline at Week 30(Baseline to Week 30)
- Percentage of Participants Who Achieve ≥5%, ≥10%, or ≥15% Body Weight Reduction from Baseline at Week 30(Baseline and Week 30)
- Number of Participants with Documented Hypoglycemia (Level 1, 2, or 3 per American Diabetes Association 2025)(From first dose until 28 days after the final dose of study treatment (34 weeks))
- Plasma Concentrations of RO7795081 at Prespecified Timepoints(Predose on Day 1 and at prespecified timepoints until Week 30)
- Incidence of Adverse Events (AEs), Adverse Events of Special Interest (AESIs), and Serious Adverse Events (SAEs)(From first dose until 28 days after the final dose of study treatment (34 weeks))
研究者
研究点 (95)
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