CTRI/2025/12/099605尚未招募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
Eli Lilly and Company (India) Pvt. Ltd.20 个研究点 分布在 1 个国家目标入组 172 人开始时间: 2026年2月1日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 172
- 试验地点
- 20
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
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants with Type 2 Diabetes:
- •Have had type 2 diabetes for at least one year
- •Insulin naive
- •Have HbA1c more than or equal to 7.5% and less than or equal to 10% at screening
- •Have body mass index (BMI) more than or equal to 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: a) heart attack, b) stroke, c) 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 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.
研究者
Dr Manish Mistry
Eli Lilly and Company (India) Pvt. Ltd
研究点 (20)
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