NCT07438444进行中（未招募）4 期
A Phase 4, Open-Label, Single-Arm, 46-Week Study to Investigate the Safety and Efficacy With Tirzepatide in Adult Indian Participants With Either Type 2 Diabetes or Obesity
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 344
- 试验地点
- 42
- 主要终点
- Number of Participants with One or More Serious Adverse Events (SAE) Considered by the Investigator to be Related to Study Drug Administration
研究概览
简要总结
The main purpose of this study is to measure the safety and efficacy of tirzepatide in adult participants in India who have type 2 diabetes or who have obesity or overweight without type 2 diabetes. Participation in the study will last about 46 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Participants with Type 2 Diabetes:
- •Have had type 2 diabetes for at least one year
- •Insulin naive
- •Have HbA1c ≥7.5% and ≤10% at screening
- •Have body mass index (BMI) ≥23 kilograms per square meter (kg/m2)
- •Participants with Obesity or Overweight without Type 2 Diabetes:
- •Have a BMI
- •Greater than or equal to 30 kg/m2 OR
- •Greater than or equal to 27 kg/m2 AND previously diagnosed with at least one of the following weight-related comorbidities: high blood pressure, lipid disorder, obstructive sleep apnea, heart disease
排除标准
- •Participants with Type 2 Diabetes:
- •Have type 1 diabetes
- •Have had any of the following heart conditions within 6 months prior to screening:
- •heart attack
- •hospitalization due to heart failure
- •Have New York Heart Association Functional Classification Class III or IV congestive heart failure (CHF)
- •Have type 2 diabetes along with morbid obesity and being considered for bariatric surgery or any other procedure intended for weight loss
- •Participants with Obesity or Overweight without Type 2 Diabetes:
- •Have type 1 diabetes or type 2 diabetes
- •Have a self-reported change in body weight greater than 5 kilograms (kg) (11 pounds) within 3 months prior to screening
- •Have a prior or planned surgical treatment for obesity
- •Have had any of the following heart conditions within 6 months prior to screening:
- •heart attack
- •hospitalization due to heart failure
- •Have New York Heart Association Functional Classification Class III or IV CHF
- •Have taken any medications or alternative remedies for weight loss within 3 months prior to screening
研究组 & 干预措施
Tirzepatide
Experimental
Participants will receive tirzepatide subcutaneously (SC)
干预措施: Tirzepatide (Drug)
结局指标
主要结局
Number of Participants with One or More Serious Adverse Events (SAE) Considered by the Investigator to be Related to Study Drug Administration
时间窗: Baseline through Week 46
A summary of treatment emergent adverse events (TEAEs), SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
次要结局
- Percentage of Participants with ≥5% Body Weight Reduction(Week 46)
- Percentage of Participants with Hemoglobin A1c (HbA1c) <7.0% in Participants with Type 2 Diabetes(Week 46)
- Change from Baseline in Waist Circumference in Participants with Obesity or Overweight(Baseline, Week 46)
研究者
研究点 (42)
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