A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes (SELENE-Asia)
A Phase III, Randomised, Double-Blind, Placebo-Controlled, Multicentre Trial to Evaluate the Efficacy and Safety of AZD6234 in Participants With Obesity or Overweight With at Least One Weight Related Comorbidity With or Without Type 2 Diabetes Mellitus (SELENE-Asia)
This study will evaluate the efficacy and safety of AZD6234 compared with placebo in adults who are overweight or obese, with or without type 2 diabetes mellitus.
研究概览
研究类型
注册 (估计的)
阶段
- 第三阶段
联系人和位置
学习联系方式
- 姓名：AstraZeneca Clinical Study Information Center
- 电话号码：1-877-240-9479
- 邮箱：information.center@astrazeneca.com
学习地点
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Beijing、中国、100029
- Research Site
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Bozhou、中国、236000
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Cangzhou、中国、061002
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Changzhou、中国、213004
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Chongqing、中国、402260
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Daqing、中国、163316
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Ganzhou、中国、341099
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Guangzhou、中国、510150
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Guangzhou、中国、510800
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Jiaxing、中国、314001
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Jinan、中国、250031
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Jinan、中国、250013
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Liuzhou、中国、545005
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Luoyang、中国、471003
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Luzhou、中国、646000
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Sanya、中国、572000
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Shanghai、中国、200031
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Shanghai、中国、310000
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Shanghai、中国、201700
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Shenyang、中国、110016
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Shenyang、中国、110023
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Shiyan、中国、442099
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Suzhou、中国、215004
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Wuhan、中国、430060
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Xi'an、中国、710068
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Xuancheng、中国、242000
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Yuncheng、中国、044099
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Zhengzhou、中国、450007
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Ansārinagar、印度、110 029
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Calicut、印度、673008
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Kolkata、印度、700014
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Ludhiana、印度、141001
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Meerut、印度、250005
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Surat、印度、395002
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Aged 18 years or older at the time of signing informed consent.
- Body mass index:
- at least 28 kg/m²; or
- at least 24 kg/m² and less than 28 kg/m² with at least one protocol-defined weight-related comorbidity, including type 2 diabetes mellitus, hypertension, dyslipidaemia, obstructive sleep apnoea, cardiovascular disease, heart failure, chronic kidney disease, metabolic dysfunction-associated steatotic liver disease, knee osteoarthritis, or stress urinary incontinence.
- Stable body weight (≤ 5% body weight change) for at least 3 months prior to Randomisation.
- Participants with type 2 diabetes mellitus must:
- have been diagnosed at least 6 months before informed consent;
- have HbA1c between 6.0% and 10.0% at Screening; and
- be managed with diet and exercise alone or with a stable dose of 1 to 3 oral glucose-lowering medications for at least 3 months before Screening.
- At least one previous self-reported unsuccessful attempt to lose body weight.
- Participants of childbearing potential must comply with protocol-defined highly effective contraception requirements and have negative pregnancy tests at Screening and Randomisation.
- Able to provide signed informed consent.
Exclusion Criteria:
- Obesity primarily caused by another endocrine disorder.
- Severe heart failure, defined as New York Heart Association Class IV, or hospitalisation for heart failure within 3 months before Screening.
- Type 1 diabetes mellitus or ketoacidosis or hyperosmolar coma/state within 3 months before Screening.
- Clinically significant gastric-emptying abnormality requiring treatment.
- Significant inflammatory bowel disease or another severe disease or prior surgery affecting the upper gastrointestinal tract.
- Cardiovascular event, percutaneous coronary intervention, or coronary artery bypass graft within 3 months before Screening.
- Previous or planned surgical treatment for obesity.
- Uncontrolled hypothyroidism or hyperthyroidism.
- Significant hepatobiliary disease, including protocol-defined elevations in alanine aminotransferase, aspartate aminotransferase, or total bilirubin.
- Neoplastic disease within 5 years before Screening, except as otherwise permitted by the protocol.
- Clinically important disease or disorder that may place the participant at risk or interfere with study participation.
- Known or suspected drug abuse or alcohol abuse.
- Planned elective surgery requiring discontinuation of study intervention for more than 6 weeks.
- Weight-management treatment within 3 months before Randomisation.
- Treatment with a glucagon-like peptide-1 receptor agonist or another glucagon-like peptide-1-containing medication within 3 months before Randomisation.
- Treatment with a marketed or investigational amylin-based compound within 3 months before Randomisation.
- Use of insulin therapy for type 2 diabetes mellitus.
- Long-term systemic glucocorticoid treatment lasting more than 14 days or use of central nervous system stimulants.
- Concomitant medication that may increase risk, affect study results, or interfere with study participation.
- Unstable major depressive disorder or Patient Health Questionnaire-9 score of 15 or higher.
- History of psychosis or active symptomatic bipolar disorder.
- Active suicidal ideation corresponding to Category 4 or 5 on the Columbia-Suicide Severity Rating Scale, or history of a suicide attempt.
- Participation in another clinical study within 30 days before Screening.
- Known hypersensitivity to AZD6234.
- Involvement in the planning and/or conduct of the study.
- Unlikely or unable to comply with study procedures, restrictions, or requirements.
- Previous randomisation in the present study.
- Currently pregnant or breastfeeding.
- Any other condition that, in the Investigator's judgement, makes participation inappropriate.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：AZD6234 Higher Target-Dose
Participants will receive AZD6234 with dose titration to the higher target dose, followed by a safety follow-up period. |
administered once weekly. |
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实验性的：AZD6234 Lower Target-Dose
Participants will receive AZD6234 with dose titration to the lower target dose, followed by a safety follow-up period. |
administered once weekly. |
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安慰剂比较：Placebo
Participants will receive matching placebo with dose titration according to the protocol, followed by a safety follow-up period. |
Matching placebo administered once weekly. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Percent change in body weight from baseline at Week 64
大体时间：up to 64 weeks
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To evaluate the effect of AZD6234 as compared to placebo in percent body weight change from baseline of treatment. |
up to 64 weeks
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Number of participants achieving at Least a 5% Reduction in Body Weight From Baseline at Week 64
大体时间：up to 64 weeks
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To evaluate the effect of AZD6234 as compared to placebo in body weight loss of at least 5% from baseline of treatment. |
up to 64 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of participants achieving at Least a 10% Reduction in Body Weight From Baseline at Week 64
大体时间：up to 64 weeks
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To evaluate the effect of AZD6234 as compared to placebo in body weight loss of at least 10% from baseline of treatment. |
up to 64 weeks
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Change in waist circumference from baseline
大体时间：up to 64 weeks
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To evaluate the effect of AZD6234 as compared to placebo in waist circumference change from baseline of treatment. |
up to 64 weeks
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Absolute change in weight from baseline
大体时间：up to 64 weeks
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To evaluate the effect of AZD6234 as compared to placebo on absolute change in weight from baseline of treatment. |
up to 64 weeks
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Percent change in triglycerides from baseline
大体时间：up to 64 weeks
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To evaluate the effect of AZD6234 as compared to placebo on triglycerides percent change from baseline of treatment. |
up to 64 weeks
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Change in systolic BP from baseline
大体时间：up to 64 weeks
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To evaluate the effect of AZD6234 as compared to placebo on systolic BP change from baseline of treatment. |
up to 64 weeks
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Number of Participants With Adverse Events
大体时间：From first administration through Week 64 and the 4-week safety follow-up
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Number of participants with prespecified adverse event categories. |
From first administration through Week 64 and the 4-week safety follow-up
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合作者和调查者
赞助
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- D8750C00019
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
IPD 共享时间框架
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD 共享访问标准
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
IPD 共享支持信息类型
- 研究方案
- 树液
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