NCT07613307招募中3 期
A Phase 3b, Multicenter, Multi-Country, Open-Label, Single-Arm Study to Investigate the Efficacy and Safety of Orforglipron in Adult Participants With Type 2 Diabetes Who Observe Ramadan Fasting (ACHIEVE-RAM)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 130
- 试验地点
- 40
- 主要终点
- Change from Baseline in Hemoglobin A1C (HbA1c)
研究概览
简要总结
The purpose of this study is to test the efficacy and safety of orforglipron in participants with T2D (type 2 diabetes) who participate in fasting during Ramadan. For each participant, the study will last up to 48 weeks with a minimum of 7 in clinic visits and 4 virtual visits.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a clinical diagnosis of T2D based on the World Health Organization (WHO) classification or other locally applicable diagnostic standards.
- •Have an HbA1c value of at least 7.0% (53 millimoles per mole (mmol/mol)) to less than 9.5% (91 mmol/mol) at screening.
- •Intend to be compliant with the fast during the Ramadan period.
- •Have had stable body weight self-reported change of 5 kilograms (kg) or lower during the 90 days prior to screening.
- •Have body mass index (BMI) of 25 kilograms per meter square (kg/m2) or higher at screening.
排除标准
- •Have any form of diabetes other than T2D, including type 1 diabetes (T1D), gestational diabetes, latent autoimmune diabetes, maturity-onset diabetes of the young, and medication-induced diabetes
- •Have a family (first-degree relative) or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type
- •Have a history of chronic or acute pancreatitis any time prior to screening
- •Have evidence of a significant, uncontrolled endocrine abnormality, for example, thyrotoxic or adrenal crises, in the opinion of the investigator
- •Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years.
- •Have a history of cholecystectomy (surgically removed gallbladder)
- •Have New York Heart Association Functional Classification IV congestive heart-failure.
研究组 & 干预措施
Orforglipron
Experimental
Administered orally
干预措施: Orforglipron (Drug)
结局指标
主要结局
Change from Baseline in Hemoglobin A1C (HbA1c)
时间窗: Baseline, up to 8 Weeks after Start of Ramadan
次要结局
- Change in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Index(Baseline, Up to 8 Weeks after Start of Ramadan)
- Percent Change in HbA1c(4 Weeks Prior to Ramadan, Up to Week 8 after Start of Ramadan])
- Percent Change in Body Weight(4 Weeks Prior to Ramadan, Up to Week 8 after Start of Ramadan])
- Percentage of Participants with an HbA1c of less than (<) 7 Percent (%) (53 millimeters per mole (mmol/mol))(Baseline, Up to 8 Weeks after Start of Ramadan)
- Change From Baseline in Fasting Serum Glucose (FSG)(Baseline, Up to 8 Weeks after Start of Ramadan)
- Percent Change from Baseline in Body Weight(Baseline, Up to 8 Weeks after Start of Ramadan)
研究者
研究点 (40)
Loading locations...
相似试验
招募中
3 期
A Study of Orforglipron (LY3502970) in Participants With Obesity or Overweight and Osteoarthritis (OA) of the Knee ( ATTAIN-OA PAIN )Osteoarthritis2025-522631-34-00Eli Lilly & Co.115
尚未招募
3 期
A Study of a Once-Daily Tablet (Orforglipron) to Improve Blood Flow in People with Peripheral Artery DiseasePeripheral vascular disease, unspecified,CTRI/2026/04/107819Eli Lilly and Company (India) Pvt. Ltd.1,205
已完成
3 期
在二甲双胍治疗后血糖控制不佳的 2 型糖尿病受试者中评价 orforglipron 与达格列净相比的作用（ACHIEVE-2）2 型糖尿病CTR20234303Eli Lilly and Company/
礼来苏州制药有限公司/
Lilly del Caribe, Inc.
进行中（未招募）
3 期
在肥胖或超重参与者中评价 orforglipron 片剂的有效性和安全性研究成人长期体重管理CTR20252894Eli Lilly and Company/
礼来苏州制药有限公司/
Lilly del Caribe, Inc.
招募中
3 期
A Study of Orforglipron (LY3502970) on Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease (ATTAIN-Outcomes)Atherosclerosis Cardiovascular DiseaseChronic Kidney Disease2025-523123-22-00Eli Lilly & Co.548