Clinical trial NCT05024032: A Study of Tirzepatide (LY3298176) in Chinese Participants Without Type 2 Diabetes Who Have Obesity or Overweight (SURMOUNT-CN)
Official title: Efficacy and Safety of Tirzepatide Once Weekly in Chinese Participants Without Type 2 Diabetes Who Have Obesity or Are Overweight With Weight-Related Comorbidities: A Randomized, Double-Blind, Placebo-Controlled Trial (SURMOUNT-CN)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obesity
Overweight
Metabolism and Nutrition Disorder
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2021-08-27
Enrollment: 210
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: This is a study of tirzepatide in Chinese participants without Type 2 Diabetes who have obesity or overweight.

The main purpose is to learn more about how tirzepatide affects body weight.


Eligibility criteria: Inclusion Criteria:

* Have a BMI ≥28 kilogram/square meter (kg/m²), or ≥24 kg/m² and previous diagnosis with at least one of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease
* Have a history of at least one self-reported unsuccessful dietary effort to lose body weight

Exclusion Criteria:

* Have Diabetes Mellitus
* Have a self-reported change in body weight \>5 kg within 3 months prior to screening
* Have obesity induced by other endocrinological disorders
* Have had a history of chronic or acute pancreatitis
* Have a history of significant active or unstable Major Depressive Disorder (MDD) or other severe psychiatric disorder within the last 2 years
* Have any lifetime history of a suicide attempt
* Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)

Primary outcomes:
measure: Mean Percent Change From Baseline in Body Weight
timeFrame: Baseline, Week 52
measure: Percentage of Participants Who Achieve ≥5% Body Weight Reduction
timeFrame: Week 52
Secondary outcomes:
measure: Mean Change From Baseline in Body Weight
timeFrame: Baseline, Week 20
measure: Percentage of Participants Who Achieve ≥10% Body Weight Reduction
timeFrame: Week 52
measure: Percentage of Participants Who Achieve ≥15% Body Weight Reduction
timeFrame: Week 52
measure: Mean Change From Baseline in Waist Circumference
timeFrame: Baseline, Week 52
measure: Mean Change From Baseline in Absolute Body Weight
timeFrame: Baseline, Week 52
measure: Mean Change From Baseline in Body Mass Index (BMI)
timeFrame: Baseline, Week 52
measure: Mean Change From Baseline in Hemoglobin A1c (HbA1c)
timeFrame: Baseline, Week 52
measure: Mean Change From Baseline in Fasting Glucose (FSG)
timeFrame: Baseline, Week 52
measure: Mean Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score
timeFrame: Baseline, Week 52
measure: Mean Change From Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score
timeFrame: Baseline, Week 52
measure: Mean Change From Baseline in Diastolic Blood Pressure (DBP) (Pooled Doses of Tirzepatide 10 mg and 15 mg)
timeFrame: Baseline, Week 52
measure: Mean Change From Baseline in Systolic Blood Pressure (SBP) (Pooled Doses of Tirzepatide 10 mg and 15 mg)
timeFrame: Baseline, Week 52
measure: Mean Change From Baseline in Total Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg)
timeFrame: Baseline, Week 52
measure: Mean Change From Baseline in High Density Lipoprotein (HDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg)
timeFrame: Baseline, Week 52
measure: Mean Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg)
timeFrame: Baseline, Week 52
measure: Mean Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg)
timeFrame: Baseline, Week 52
measure: Mean Change From Baseline in Triglycerides (Pooled Doses of Tirzepatide 10 mg and 15 mg)
timeFrame: Baseline, Week 52
measure: Mean Change From Baseline in Free Fatty Acids (Pooled Doses of Tirzepatide 10 mg and 15 mg)
timeFrame: Baseline, Week 52
measure: Mean Change From Baseline in Fasting Insulin (Pooled Doses of Tirzepatide 10 mg and 15 mg)
timeFrame: Baseline, Week 52
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tsinghua Changgung Hospital
state: Beijing
city: Chongqing
country: China
facility: The First Affiliated Hospital Chongqing Medical University
state: Chongqing
city: Guangzhou
country: China
facility: Zhujiang Hospital
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen Second People's Hospital
state: Guangdong
city: Qinhuangdao
country: China
facility: The First Hospital of Qinhuangdao
state: Hebei
city: Harbin
country: China
facility: The Fourth Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Luoyang
country: China
facility: The First Affiliated Hospital of Henan University of Science &Technology
state: Henan
city: Zhengzhou
country: China
facility: The Second Affiliated Hospital of Zhengzhou University
state: Henan
city: Hengyang
country: China
facility: The First Affiliated Hospital of Nanhua University
state: Hunan
city: Changzhou
country: China
facility: Changzhou No.2 People's Hospital
state: Jiangsu
city: Nanjing
country: China
facility: The Second Affiliated Hospital of Nanjing Medical University
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing Medical University - Nanjing Jiangning Hospital
state: Jiangsu
city: Nantong
country: China
facility: Affiliated Hospital of Nantong University
state: Jiangsu
city: Wuxi
country: China
facility: Wuxi People's Hospital
state: Jiangsu
city: Changchun
country: China
facility: The Second Hospital of Jilin University
state: Jilin
city: Siping
country: China
facility: Siping Central People's Hospital
state: Jilin
city: Jinan
country: China
facility: Jinan Central Hospital
state: Shandong
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Huadong Hospital Affiliated to Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Hospital of Traditional Chinese Medicine
state: Shanghai
city: Shanghai
country: China
facility: Qingpu Branch of Zhongshan Hospital, Fudan University
state: Shanghai
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Medical University
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
city: Hangzhou
country: China
facility: The First People's Hospital of Hangzhou
state: Zhejiang
city: Huzhou
country: China
facility: Huzhou Central Hospital
state: Zhejiang
city: Ningbo
country: China
facility: Ningbo First Hospital
state: Zhejiang
city: Shanghai
country: China
facility: The Fifth People's Hospital of Shanghai
city: Shanghai
country: China
facility: Shanghai Minhang District Central Hospital
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: