Clinical trial NCT05963022: A Study of Tirzepatide (LY3298176) in Chinese Participants With Type 2 Diabetes (SURPASS-CN-MONO)
Official title: A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Tirzepatide Monotherapy Compared With Placebo in Chinese Participants With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2023-07-27
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to investigate the efficacy and safety of Tirzepatide monotherapy in Chinese participants with Type 2 Diabetes.


Eligibility criteria: Inclusion Criteria:

* Have Type 2 Diabetes
* 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 Type 1 Diabetes
* 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.

Primary outcomes:
measure: Change from Baseline in Hemoglobin A1c (HbA1c)
timeFrame: Baseline, Week 40
Secondary outcomes:
measure: Percentage of Participants with HbA1c Target Values of <7.0% (<53 mmol/mol)
timeFrame: Week 40
measure: Change from Baseline in Fasting Serum Glucose
timeFrame: Baseline, Week 40
measure: Percentage of Participants with HbA1c Target Values of ≤6.5% (≤48 mmol/mol)
timeFrame: Week 40
measure: Change from Baseline in Body Weight
timeFrame: Baseline, Week 40
measure: Percentage of Participants with HbA1c Target Values of <5.7% (<39 mmol/mol)
timeFrame: Week 40
measure: Change from Baseline in Daily Average 7-Point Self-Monitored Blood Glucose Profiles (SMBG)
timeFrame: Baseline, Week 40
measure: Percentage of Participants Who Achieved Weight loss of ≥5%
timeFrame: Week 40
measure: Percentage of Participants Who Achieved Weight loss of ≥10%
timeFrame: Week 40
measure: Percentage of Participants Who Achieved Weight loss of ≥15%
timeFrame: Week 40
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
city: Foshan
country: China
facility: Shunde Hospital of Southern Medical Univesity
state: Guangdong
city: Huizhou
country: China
facility: Huizhou Municipal Central Hospital
state: Guangdong
city: Zunyi
country: China
facility: Zunyi First People's Hospital
state: Guizhou
city: Haikou
country: China
facility: Hainan General Hospital
state: Hainan
city: Harbin
country: China
facility: The Fourth Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Luoyang Shi
country: China
facility: The First Affiliated Hospital of Henan University of Science &Technology
state: Henan
city: Nanyang
country: China
facility: The First Affiliated Hospital of Nanyang Medical College
state: Henan
city: Zhengzhou
country: China
facility: The Second Affiliated Hospital of Zhengzhou University
state: Henan
city: Yichang
country: China
facility: Yichang Central People's Hospital
state: Hubei
city: Changde
country: China
facility: The First People's Hospital of Changde City
state: Hunan
city: Nanjing
country: China
facility: The Second Affiliated Hospital of Nanjing Medical University
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing Medical University - Nanjing Jiangning Hospital
state: Jiangsu
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
city: Zhenjiang
country: China
facility: Affiliated Hospital of Jiangsu University
state: Jiangsu
city: Pingxiang
country: China
facility: Jiangxi Pingxiang People's Hospital
state: Jiangxi
city: Dalian
country: China
facility: Dalian University - The Affiliated Zhongshan Hospital
state: Liaoning
city: Dalian
country: China
facility: Dalian Municipal Central Hospital Affiliated of Dalian Medical University
state: Liaoning
city: Liaoyou
country: China
facility: Panjin Liaoyou Baoshihua Hospital
state: Liaoning
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Medical University
state: Shaanxi
city: Jinan
country: China
facility: Jinan Central Hospital
state: Shandong
city: Shanghai
country: China
facility: Pudong New Area People's Hospital Shanghai
state: Shanghai
city: Shanghai
country: China
facility: Jiading District Central Hospital
state: Shanghai
city: Cheng Du
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Chengdu
country: China
facility: Chengdu Fifth People's Hospital
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
city: Huzhou
country: China
facility: Huzhou Central Hospital
state: Zhejiang
Study officials:
affiliation: Eli Lilly and Company
name: 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
References: