Clinical Trials List
Protocol NumberJ2A-MC-GZPW
NCT Number(ClinicalTrials.gov Identfier)NCT07241390
Active
2026-01-01 - 2031-09-18
Phase III
Not yet recruiting1
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Event-Driven Study to Investigate the Effect of Orforglipron on the Incidence of Major Adverse Cardiovascular Events in Participants with Established Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease (ATTAIN-Outcomes)
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Trial Applicant
ELI LILLY AND COMPANY(TAIWAN), INC.
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Sponsor
ELI LILLY AND COMPANY(TAIWAN), INC.
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Trial scale
Multi-Regional Multi-Center
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Update
2026/09/11
Investigators and Locations
Co-Principal Investigator
- Ye-Hsu Lu 無
- Cheng-An Chiu 無
- Chun-Yuan Chu 無
- 吳韋璁 無
- 黃天祈 無
Co-Principal Investigator
- Ping-Yen Liu 無
- 吳至行 無
- 李文煌 無
- Wei-Hung Lin 無
- 張尹凡 無
- 張秦松 無
- 張獻元 無
Co-Principal Investigator
- Yung-Ta Kao 無
- Chien-Yi Hsu 無
- 洪元 無
- 陳志維 無
- 蕭卜源 無
- 鄭宇倫 無
- 陳彥舟 無
Co-Principal Investigator
- MAO-HSIN LIN 無
- YEN-HUNG LIN 無
- Tzung-Dau Wang 無
- JEN-KUANG LEE 無
- 陳盈憲 無
- CHO-KAI WU 無
- Chih-Fan Yeh 無
- 林柏志 無
- 黃慶昌 無
- 孟士瑋 無
- 蘇乾嘉 無
- 柯宗佑 無
Co-Principal Investigator
- Chern-En Chiang 無
- Wen-Chung Yu 無
- Kang-Ling Wang 無
- Tse-Min Lu 無
- I-Ming Chen 無
- 吳承學 無
- 黃偉銘 無
- 張俊欽 無
- 游偉光 無
- 張皓智 無
- 郭姿廷 無
- 陳泰位 無
Principal Investigator
Pao-Hsien Chu
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Condition/Disease
Atherosclerosis Cardiovascular Disease Chronic Kidney Disease
Objectives
The purpose of this study is to measure cardiovascular outcomes with orforglipron compared with placebo in participants with atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD). Participation in the study will last about 5 years.
Test Drug
Orforglipron (LY3502970)
Placebo
Placebo
Active Ingredient
Orforglipron (LY3502970)
Placebo
Placebo
Dosage Form
Tablet
Tablet
Tablet
Dosage
MG
MG
MG
Endpoints
Time to First Occurrence of Composite Endpoint of Major Cardiovascular Events Composite endpoint includes nonfatal myocardial infarction, nonfatal stroke, hospitalization or urgent visit due to heart failure, coronary revascularization, or all-cause death Baseline up to end of study (about 5 years)
Inclution Criteria
Have established ASCVD and/or CKD
Exclusion Criteria
Have type 1 diabetes
Have had a major heart condition within 60 days prior to screening
Have New York Heart Association Functional Classification Class IV heart failure
Have had a major heart condition within 60 days prior to screening
Have New York Heart Association Functional Classification Class IV heart failure
The Estimated Number of Participants
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Taiwan
166 participants
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Global
7140 participants