A Study of Tirzepatide (LY3298176) in Chinese Participants With Type 2 Diabetes (SURPASS-CN-MONO)
NCT ID: NCT05963022
Last Updated: 2025-10-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
206 participants
INTERVENTIONAL
2023-08-21
2024-10-09
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 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 ≤9.5% (≤80 mmol/mol) despite diet and exercise treatment
* Are of stable weight 5%) during the 90 days preceding screening and agree not to initiate a diet and/or exercise program during the study with the intent of reducing body weight other than the lifestyle and dietary measures for diabetes treatment
* Have Body Mass Index (BMI) ≥23.0 kilogram per square meter (kg/m²)
Exclusion Criteria
* Have a history of chronic or acute pancreatitis any time prior to study entry
* Are currently receiving treatment for diabetic retinopathy and/or macular edema
* Have a history of ketoacidosis or hyperosmolar state/coma
* Have a history of New York Heart Association Functional Classification IV congestive heart failure (CHF)
* Have acute or chronic hepatitis including a history of autoimmune hepatitis
* Use of insulin 1-year preceding screening and between screening and baseline; use of any antihyperglycemic medication 90 days preceding screening and between screening and baseline.
18 Years
ALL
No
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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Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Shunde Hospital of Southern Medical Univesity
Foshan, Guangdong, China
Huizhou Municipal Central Hospital
Huizhou, Guangdong, China
Zunyi First People's Hospital
Zunyi, Guizhou, China
Hainan General Hospital
Haikou, Hainan, China
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang Shi, Henan, China
The First Affiliated Hospital of Nanyang Medical College
Nanyang, Henan, China
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Yichang Central People's Hospital
Yichang, Hubei, China
The First People's Hospital of Changde City
Changde, Hunan, China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Nanjing First Hospital
Nanjing, Jiangsu, China
Nanjing Medical University - Nanjing Jiangning Hospital
Nanjing, Jiangsu, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, China
Jiangxi Pingxiang People's Hospital
Pingxiang, Jiangxi, China
Dalian University - The Affiliated Zhongshan Hospital
Dalian, Liaoning, China
Dalian Municipal Central Hospital Affiliated of Dalian Medical University
Dalian, Liaoning, China
Panjin Liaoyou Baoshihua Hospital
Liaoyou, Liaoning, China
The First Affiliated Hospital of Xi'an Medical University
Xi'an, Shaanxi, China
Jinan Central Hospital
Jinan, Shandong, China
Pudong New Area People's Hospital Shanghai
Shanghai, Shanghai Municipality, China
Jiading District Central Hospital
Shanghai, Shanghai Municipality, 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-GPIU
Identifier Type: OTHER
Identifier Source: secondary_id
18746
Identifier Type: -
Identifier Source: org_study_id
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