NCT07784270招募中3 期
A Phase III Randomized, Double-Blind, Placebo-Controlled Multicentre Trial to Evaluate the Efficacy and Safety of AZD6234 in Participants With Type 2 Diabetes Mellitus and Obesity or Overweight (SELENE 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
- 发起方
- AstraZeneca
- 入组人数
- 1,500
- 试验地点
- 227
- 主要终点
- Percent change in body weight from baseline at 68 weeks of treatment.
研究概览
简要总结
The study will evaluate how well AZD6234 works and how safe it is in adults with excess weight or obesity. Efficacy of AZD6234 will be compared to placebo in percent body weight change from baseline at 68 weeks of treatment
详细描述
This is a Phase III, global, randomized, parallel-group, double-blind, multicentre study to assess the efficacy and safety of AZD6234 compared with placebo in adults with Type 2 Diabetes Mellitus (T2DM) and obesity or overweight. Eligible participants will be randomized to either receive AZD6234 or matching placebo respectively.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Males & females (inclusive of all gender identities) age ≥18 years
- •BMI ≥27 kg/m2
- •Diagnosed with T2DM ≥90 days prior to Screening
- •HbA1c value at Screening of ≥6.0% (42 mmol/mol) and ≤10% (86 mmol/mol) managed with diet and exercise alone or with a stable dose of any oral glycaemic-lowering agent (as per local labelling)
- •Stable body weight (≤5% body weight change) for at least 3 months prior to Randomisation
- •History of at least one self-reported unsuccessful attempt to lose body weight in lifetime
排除标准
- •Obesity primarily caused by other endocrine disorders
- •Type 1 diabetes mellitus (or any other diabetes mellitus that is not clearly Type 2 diabetes), OR have history of ketoacidosis or hyperosmolar coma/state within 3 months prior to Screening
- •Significant hepatobiliary disease and/or any of the following results at Screening:
- •ALT ≥ 3.0 X ULN
- •AST ≥ 3.0 X ULN
- •TBL > 1.5 X ULN (except for cases of known Gilbert's Syndrome)
- •Has received treatment with a GLP-1 receptor agonist or GLP-1 containing medication for any indication within 3 months before Randomisation
- •Use of insulin therapy for T2DM within 3 months prior to screening
研究组 & 干预措施
Placebo
Placebo Comparator
Matching placebo
干预措施: Placebo (Drug)
AZD6234 Dose 2
Experimental
AZD6234 Dose 2
干预措施: AZD6234 (Drug)
AZD6234 Dose 1
Experimental
AZD6234 Dose 1
干预措施: AZD6234 (Drug)
结局指标
主要结局
Percent change in body weight from baseline at 68 weeks of treatment.
时间窗: 68 weeks
To evaluate the effect of AZD6234 compared to placebo in percent body weight change
次要结局
- Absolute change in weight (kg) from baseline at 68 weeks of treatment(68 weeks)
- Achievement of at least 5 % body weight loss from baseline at 68 weeks of treatment(68 weeks)
- Achievement of at least 10 % body weight loss from baseline at 68 weeks of treatment(68 weeks)
- Change in haemoglobin A1C from baseline at 68 weeks of treatment(68 weeks)
- Change in waist circumference (cm) from baseline at 68 weeks of treatment(68 weeks)
- Percent change in triglycerides from baseline at 68 weeks of treatment(68 weeks)
- Change in systolic blood pressure (mmHg) from baseline at 68 weeks of treatment(68 weeks)
- Percent change in fat mass from baseline at 68 weeks of treatment measured by DXA in the DXA Sub-Study subset(68 weeks)
研究者
研究点 (227)
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