2025-523933-24-00招募中3 期
A Randomized, Open-label, Parallel-group Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Elecoglipron Compared with Oral Semaglutide in Adults with Type 2 Diabetes Mellitus (Eluminate-2)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 335
- 试验地点
- 47
- 主要终点
- Change from baseline to Week 52 in HbA1c (%)
研究概览
简要总结
To evaluate the efficacy of elecoglipron compared with oral semaglutide for glycemic control
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with T2DM for at least 90 days prior to screening
- •T2DM inadequately managed with lifestyle management alone or up to 2 oral glucose-lowering medications
- •HbA1c value of ≥ 7% to ≤ 10.5% (53 to 91.3 mmol/mol)
- •Increased risk of CV events defined by ≥1 of: documented coronary heart disease, peripheral arterial disease, ischemic cerebrovascular disease, or heart failure (NYHA II–III); or ≥2 CV risk factors
- •BMI of ≥ 23 kg/m2 at screening
- •Stable body weight (self-reported or documented) for 90 days prior to screening
排除标准
- •T1DM, secondary forms of diabetes (including congenital forms), or history of ketoacidosis or hyperosmolar coma
- •Currently receiving or anticipated to receive, therapeutic intervention for diabetic retinopathy and/or macular edema
- •Have had more than one episode of severe hypoglycemia within 180 days prior to screening or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms
- •Clinically significant condition affecting the upper GI tract or chronic use of any medication that affects gastric motility or gastric emptying
- •History of acute or chronic pancreatitis
- •Severe congestive heart failure (NYHA IV)
- •History/family history of medullary thyroid cancer or multiple endocrine neoplasia type 2
研究组 & 干预措施
Rybelsus 4 mg tablets, Rybelsus 1.5 mg tablets, Rybelsus 9 mg tablets
Comparator
干预措施: Rybelsus 1.5 mg tablets (Drug)
Rybelsus 4 mg tablets, Rybelsus 1.5 mg tablets, Rybelsus 9 mg tablets
Comparator
干预措施: Rybelsus 9 mg tablets (Drug)
Elecoglipron, Elecoglipron, Elecoglipron, Elecoglipron
Test
干预措施: Elecoglipron (Drug)
Rybelsus 4 mg tablets, Rybelsus 1.5 mg tablets, Rybelsus 9 mg tablets
Comparator
干预措施: Rybelsus 4 mg tablets (Drug)
结局指标
主要结局
Change from baseline to Week 52 in HbA1c (%)
Change from baseline to Week 52 in HbA1c (%)
次要结局
- Percent change from baseline to Week 52 in body weight
- Change from baseline to Week 52 in body weight (kg)
- Achieved ≥ 5% weight loss from baseline at Week 52 and achieved HbA1c < 7% (53 mmol/mol) at Week 52
- Achieved HbA1c ≤ 6.5% (48 mmol/mol) at Week 52
- Achieved HbA1c < 7% (53 mmol/mol) at Week 52
研究者
AstraZeneca Clinical Study Information Center
Scientific
AstraZeneca AB
研究点 (47)
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