A Study of Tirzepatide (LY3298176) in Chinese Participants With Type 2 Diabetes
NCT ID: NCT05691712
Last Updated: 2025-08-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
257 participants
INTERVENTIONAL
2023-02-05
2024-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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5 Milligram (mg) Tirzepatide
Participants received 5 mg of tirzepatide administered as subcutaneous (SC) injection via a single-dose injection pen (SDP) once weekly (QW) for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached.
Tirzepatide
Administered SC
10 mg Tirzepatide
Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached.
Tirzepatide
Administered SC
15 mg Tirzepatide
Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached.
Tirzepatide
Administered SC
Placebo
Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks.
Placebo
Administered SC
Interventions
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Tirzepatide
Administered SC
Placebo
Administered SC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have HbA1c ≥7.0% (53 mmol/mol) to ≤11% (97 mmol/mol)
* Have been treated with insulin glargine (U100) once daily alone, or in combination with metformin with or without SGLT-2i ≥90 days
* Have a body mass index (BMI) ≥23 kilograms per meter squared (kg/m²)
Exclusion Criteria
* Have a history of chronic or acute pancreatitis
* Have proliferative diabetic retinopathy or diabetic macular edema or nonproliferative diabetic retinopathy that requires acute treatment
* Have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2
* Have a history of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months
* Have a history of diabetic ketoacidosis or hyperosmolar state/coma within the 6 months
* Have acute myocardial infarction, or cerebrovascular accident (stroke) or hospitalization due to congestive heart failure (CHF) in the past 2 months
* Have a serum calcitonin level of ≥35 ng/L, as determined by central laboratory
* Have acute or chronic hepatitis, signs, and symptoms of any other liver disease other than nonalcoholic fatty liver disease (NAFLD), or alanine aminotransferase (ALT) level \>3.0 times the upper limit of normal (ULN), as determined by the central laboratory at study entry; participants with NAFLD are eligible for participation in this trial only if their ALT level is ≤3.0 times ULN.
18 Years
ALL
Yes
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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The Second People's Hospital of Hefei
Hefei, Anhui, China
Beijing Hospital
Beijing, Beijing Municipality, China
Beijing Pinggu District Hospital
Beijing, Beijing Municipality, China
Chongqing General Hospital
Chongqing, Chongqing Municipality, China
Huizhou Municipal Central Hospital
Huizhou, Guangdong, China
The First Hospital of Harbin Medical University
Harbin, Heilongjiang, China
The Fourth Hospital of Harbin Medical University
Harbin, Heilongjiang, China
The First Affiliated Hospital of Henan University of Science &Technology
LuoyangShi, Henan, China
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
The First People's Hospital of Yueyang
Yueyang, Hunan, China
Baotou Central Hospital
Baotou, Inner Mongolia, China
Changzhou No.2 People's Hospital
Changzhou, Jiangsu, China
Nanjing First Hospital
Nanjing, Jiangsu, China
Zhongda Hospital Southeast University
Nanjing, Jiangsu, China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Wuxi People's Hospital
Wuxi, Jiangsu, China
The Affiliated Jiangyin Hospital of Southeast University Medical College
WuxiShi, Jiangsu, China
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, China
The Third Hospital of Nanchang
Nanchang, Jiangxi, China
The First Affiliated Hospital of Xi'an Medical University
Xi'an, Shaanxi, China
Jinan Central Hospital
Jinan, Shandong, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Chengdu Fifth People's Hospital
Chengdu, Sichuan, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
Huzhou Central Hospital
Huzhou, Zhejiang, China
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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I8F-MC-GPIM
Identifier Type: OTHER
Identifier Source: secondary_id
18552
Identifier Type: -
Identifier Source: org_study_id
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