A Phase II Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and Tolerability of AZD6234 in Participants Living With Overweight or Obesity With Type 2 Diabetes Who Are on a Stable Dose of GLP-1 Receptor Agonist
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- AstraZeneca
- 入组人数
- 69
- 试验地点
- 19
- 主要终点
- Percent change in body weight from baseline at Study Week 26
研究概览
简要总结
This Phase II study is a randomized, parallel group, double blinded, placebo-controlled, multicenter to evaluate the efficacy, safety, and tolerability of AZD6234 in adults with overweight or obesity and type 2 diabetes on stable GLP-1 RA therapy.
详细描述
This is a Phase II, randomised, parallel-group, double-blind, placebo-controlled, multi-centre study to assess the efficacy, safety, and tolerability of AZD6234 compared with placebo, given once weekly as a subcutaneous (SC) injection, in adults living with overweight or obesity and type 2 diabetes who are on a stable dose of GLP-1 RA. The study is being conducted across sites in the USA to evaluate the efficacy, safety, and tolerability of AZD6234 in adults with overweight or obesity and type 2 diabetes on stable GLP-1 RA therapy. A total of 64 Participants, aged 18-75 with a BMI ≥ 27 kg/m², will be randomized to receive weekly subcutaneous injections of either AZD6234 or a placebo, alongside their current GLP-1 RA medication. The study involves a screening period and a treatment and follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
This study will be conducted as double-blind through its duration, with participants, investigators, and site staff remaining blinded to treatment allocation. At the time of the interim analysis, Sponsor and designated CRO staff will be unblinded to treatment allocations solely for statistical analysis or operational management. Investigators, site staff, and participants will remain blinded for the entire study duration.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be 18 to 75 years old at the time of signing the informed consent.
- •Diagnosed with type 2 diabetes ≥ 180 days before screening.
- •HbA1c value at screening of ≥ 6.0% (42 mmol/mol) and ≤ 10% (86 mmol/mol).
- •On a stable maintenance dose of an injectable GLP-1 RA.
- •At Screening, have a BMI ≥ 27 kg/m2
排除标准
- •Has received treatment with prescription or non-prescription medication for weight loss within the last 3 months prior to screening (other than a GLP-1 RA).
- •Self-reported weight change of > 5 % in the 3 months prior to screening.
- •Diabetes mellitus that is not clearly type 2 diabetes.
- •Use of insulin therapy for T2DM
- •Previous or planned (within study period) bariatric surgery or fitting of a weight loss device (eg, gastric balloon or duodenal barrier)
- •Significant hepatobiliary disease (except for non-alcoholic steatohepatitis or nonalcoholic fatty liver disease without portal hypertension or cirrhosis)
- •8. Impaired renal function defined as eGFR ≤ 45 mL/minute/1.73m2 at screening
研究组 & 干预措施
AZD6234
Weekly SC injections of AZD6234
干预措施: AZD6234 (Drug)
Placebo for AZD6234
Weekly SC injections of matching placebo
干预措施: Placebo to match (Drug)
结局指标
主要结局
Percent change in body weight from baseline at Study Week 26
时间窗: From baseline to week 26
To determine whether treatment with AZD6234 is superior to placebo for weight loss at Study Week 26
Weight loss ≥ 5% from baseline at Study Week 26
时间窗: From baseline to week 26
To assess the effect of AZD6234 versus placebo on the proportion of participants with weight loss ≥ 5% from baseline at Study Week 26
次要结局
- Weight loss ≥ 10% from baseline at Study Week 26(From baseline to week 26)
- Absolute change in body weight (kg) from baseline at Study Week 26(From baseline to week 26)
- Change in HbA1c from baseline at Study Week 26.(From baseline to week 26)
- AZD6234 plasma concentrations(From baseline to week 26)
- Change in serum glucose from baseline at Study Week 26.(From baseline to week 26)