NCT07743450招募中3 期
A Phase III, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Once-Daily Oral ASC30 in Adult Participants With Obesity or Overweight With Type 2 Diabetes Mellitus (AURORA-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
- 1,560
- 试验地点
- 136
- 主要终点
- Percent change from baseline in body weight
研究概览
简要总结
Study ASC30-302 (AURORA-2) is a Phase III, global, multicenter, randomized, double-blind, placebo-controlled study to investigate the long-term efficacy, safety, and tolerability of three maintenance doses of once-daily oral ASC30 compared with placebo in participants with obesity or overweight and T2DM.
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
- Triple (Participant, Care Provider, 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
- •Participant must be ≥18 years of age inclusive, or the legal age of consent in the jurisdiction in which the study is taking place at screening.
- •Have a BMI ≥ 27 kg/m2 at screening.
- •Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.
- •Have a diagnosis of T2D according to the WHO classification or other locally applicable standards, with HbA1c > 6.5% (48 mmol/mol) to ≤10.5% (91 mmol/mol) at screening.
排除标准
- •Have Type 1 Diabetes Mellitus (T1DM), history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except T2DM.
- •Have a self-reported change in body weight >5 kg (11 pounds) within 3 months prior to screening.
- •Have an estimated glomerular filtration rate (eGFR) < 15 mL/min/1.73 m2, as determined by the laboratory at screening.
- •Have a history of acute or chronic pancreatitis any time prior to screening.
- •Have known allergies or intolerance to glucagon-like peptide-1 Receptor Agonists (GLP-1 RA).
- •Participants with a personal or family (first-degree relative) history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia (MEN) syndrome type
- •Are currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study at the investigator's discretion.
研究组 & 干预措施
ASC30 Cohort 1
Experimental
Participants will receive oral ASC30 tablets A1.
干预措施: ASC30 tablets A1 (Drug)
ASC30 Cohort 2
Experimental
Participants will receive oral ASC30 tablets A1.
干预措施: ASC30 tablets A1 (Drug)
ASC30 Cohort 3
Experimental
Participants will receive oral ASC30 tabletsA1.
干预措施: ASC30 tablets A1 (Drug)
Placebo Cohort 4
Placebo Comparator
Participants will receive matching placebo tablets orally once daily.
干预措施: Placebo (Drug)
结局指标
主要结局
Percent change from baseline in body weight
时间窗: Baseline to Week 72
次要结局
- Change from baseline in BMI (kg/m²)(Baseline to Week 72)
- Change from baseline in fasting insulin (pmol/L)(Baseline to Week 72)
- Change from baseline in waist circumference (cm)(Baseline to Week 72)
- Change from baseline in diastolic blood pressure (DBP) (mmHg)(Baseline to Week 72)
- Change from baseline in HbA1c (%)(Baseline to Week 72)
- Change from baseline in fasting serum glucose (mg/dL)(Baseline to Week 72)
- Change from baseline in systolic blood pressure (SBP) (mmHg)(Baseline to Week 72)
- Percent change from baseline in fasting non-HDL cholesterol(Baseline to Week 72)
- Percent change from baseline in fasting triglycerides(Baseline to Week 72)
- Percent change from baseline in fasting total cholesterol(Baseline to Week 72)
研究者
研究点 (136)
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