NCT05680155已完成3 期
A Phase 3, Multi-center, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of XW003 in Patients With T2DM Inadequately Controlled by Diet and Exercise Alone
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 211
- 试验地点
- 1
- 主要终点
- Change from baseline in HbA1c
研究概览
简要总结
The main purpose of this study is to investigate the efficacy and safety of XW003 versus placebo in patients with type 2 diabetes mellitus (T2DM) inadequately controlled by diet and exercise alone
详细描述
In this Phase 3 study, eligible participants will be randomized in a 2:2:1:1 ratio to receive once-weekly subcutaneous XW003 (high or low dose) or volume matching placebo as an adjunct to lifestyle intervention for 24 weeks. The core treatment phase will be followed by a 28-week open-label period where all participants receive XW003.
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
- Double (Participant, Investigator)
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
- 否
入选标准
- •Ability and willingness to participate in the study, give written informed consent, and comply with the study specific requirements and all protocol procedures.
- •Sex: male or female; Age: 18 to 75 years, inclusive
- •BMI: 20.0 kg/m^2 to 35.0 kg/m^2, inclusive
- •Have been diagnosed with T2DMthat is inadequately controlled with at least 3 months of diet and exercise prior to screening.
- •HbA1c ranging from 7.5% to 11.0% at screening, inclusive
- •FPG ≤13.9 mmol/L at screening.
排除标准
- •History of type 1 or other types of diabetes mellitus.
- •Use of any GLP-1 analogue during the 3 months preceding to screening.
- •History of proliferative diabetic retinopathy, diabetic maculopathy, diabetic neuropathy, or diabetic foot during the 6 months preceding screening.
- •History of acute or chronic pancreatitis or high risk factors for pancreatitis.
- •Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type
- •History of stomach surgeries or disorders associated with slowed emptying of the stomach during the past 6 months.
- •History of heart attack, stroke, or congestive heart failure of Grade 3 or 4 in the past 6 months.
研究组 & 干预措施
C1-XW003
Experimental
High dosage of XW003 once weekly
干预措施: Ecnoglutide (Drug)
C1-Placebo
Placebo Comparator
Matched Placebo once weekly
干预措施: Placebo (Drug)
C2-XW003
Experimental
Low dosage of XW003 once weekly
干预措施: Ecnoglutide (Drug)
C2-Placebo
Placebo Comparator
Matched Placebo once weekly
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in HbA1c
时间窗: Baseline, Week 24
次要结局
- Change from baseline in HbA1c(Baseline, Week 5, Week 9, Week 13, Week 17, Week 29, Week 33, Week 37, Week 45, Week 52)
- Proportion of subjects with HbA1c < 7% and HbA1c ≤6.5% after treatment(week 24, week 52)
- Proportion of subjects with HbA1c < 7%, with no severe hypoglycemia or no weight gain(week 24)
- Change from baseline in fasting plasma glucose (FPG)(Baseline, Week 24 and Week 52)
- Change from baseline in fasting insulin(Baseline, Week 24 and Week 52)
- Change from baseline in lipid panel(Baseline, Week 24 and Week 52)
- Change from baseline in 2-hour postprandial blood glucose(Baseline, Week 24 and Week 52)
- Change from baseline in 7-point self-monitored blood glucose(Baseline, Week 24 and Week 52)
- Change from baseline in HOMA-IR(Baseline, Week 24 and Week 52)
- Change from baseline in waist circumference(Baseline, Week 24 and Week 52)
- Change from baseline in hip circumference(Baseline, Week 24 and Week 52)
- Change from baseline in HOMA-β(Baseline, Week 24 and Week 52)
- Change from baseline in body weight(Baseline, Week 24 and Week 52)
研究者
研究点 (1)
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