2024-520322-11-00招募中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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 74
- 试验地点
- 30
- 主要终点
- Change in HbA1c from baseline at Week 30
研究概览
简要总结
To evaluate the effect of RO7795081, compared with placebo, on glycated hemoglobin (HbA1c)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Have a diagnosis of T2D according to the WHO classification or other locally applicable standards 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 per approved local label. Participants on metformin, SGLT-2 inhibitor, or metformin and SGLT-2 inhibitors must be on a stable therapy for ≥ 3 months prior to the screening visit
- •BMI ≥ 23.0 kg/m2 at screening
- •Have had a stable body weight within 3 months prior to screening (maximum 5% self-reported body weight gain and/or loss)
- •Agreement to adhere to the contraception requirements
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. Any participant who the Investigator feels would not be able to communicate an understanding of hypoglycemic symptoms and the appropriate treatment of hypoglycemia should also be excluded
- •History or presence of proliferative diabetic retinopathy, diabetic macular edema, or non-proliferative diabetic retinopathy that requires acute treatment based on a dilated fundoscopic examination or with retinal photography as part of a quality assured diabetes retinal screening program (WHO 2020) performed within 12 months prior to screening. If the participant has not had a dilated fundoscopic examination or retinal photography within 12 months prior to screening, or if the Investigator believes further examination is required, then participants are allowed to have one performed during the screening period before randomization.
- •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, including but not limited to insulin, dipeptidyl peptidase-4 (DPP-4) inhibitors, glucagon-like peptide 1 (GLP-1) or GLP-1/ glucose-dependent insulinotropic polypeptide (GIP) receptor agonists (RAs), sulfonylurea, and amylin analogs
结局指标
主要结局
Change in HbA1c from baseline at Week 30
Change in HbA1c from baseline at Week 30
次要结局
- Change in HbA1c from baseline at Week 30
- Percentage of participants with HbA1c < 5.7%, ≤ 6.5%, and < 7.0% at Week 30
- Change in fasting plasma glucose from baseline at Week 30
- Percent (%) change in body weight from baseline at Week 30
- Absolute change in body weight (kg) from baseline at Week 30
- Percentage of participants who achieve ≥ 5%, ≥ 10%, or ≥ 15% body weight reduction at Week 30
- Incidence of AEs, AESIs, and SAEs
- Number of participants with documented hypoglycemia (Level 1, 2, or 3 per ADA 2024)
- Change in safety laboratory values and vital signs
- Change in ECG parameters
- Plasma concentrations of RO7795081
研究者
Trial Information System - TISL
Scientific
F. Hoffmann-La Roche AG
研究点 (30)
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