A Study of Tirzepatide (LY3298176) in Chinese Participants Without Type 2 Diabetes Who Have Obesity or Overweight (SURMOUNT-CN)
- Conditions
- OverweightObesityMetabolism and Nutrition Disorder
- Interventions
- Drug: PlaceboDrug: Tirzepatide
- Registration Number
- NCT05024032
- Lead Sponsor
- Eli Lilly and Company
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 210
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants received matching placebo SC QW. 15 mg Tirzepatide Tirzepatide Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW. 10 Milligrams (mg) Tirzepatide Tirzepatide Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, and then 10 mg tirzepatide administered subcutaneously (SC) once weekly (QW).
- Primary Outcome Measures
Name Time Method Mean Percent Change From Baseline in Body Weight Baseline, Week 52 Mean Percent Change from Baseline in Body Weight. Least squares (LS) mean was determined using mixed model repeated measures (MMRM) model with Baseline + Sex + Presence of Comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Percentage of Participants Who Achieve ≥5% Body Weight Reduction Week 52 Percentage of Participants who Achieve ≥5% Body Weight Reduction. A logistic regression model was used for this analysis.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Who Achieve ≥10% Body Weight Reduction Week 52 Percentage of Participants who Achieve ≥10% Body Weight Reduction. A logistic regression model was used for this analysis.
Percentage of Participants Who Achieve ≥15% Body Weight Reduction Week 52 Percentage of Participants who Achieve ≥15% Body Weight Reduction. A logistic regression model was used for this analysis.
Mean Change From Baseline in Body Weight Baseline, Week 20 Mean Change from Baseline in Body Weight. LS mean was determined using MMRM model with Baseline + Sex + Presence of comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Mean Change From Baseline in Absolute Body Weight Baseline, Week 52 Mean Change from Baseline in Absolute Body Weight. LS mean was determined using MMRM model with Baseline + Sex + Presence of comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Mean Change From Baseline in High Density Lipoprotein (HDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg) Baseline, Week 52 LS mean was determined using MMRM model using log (Actual Measurement) = log (Baseline) + Sex + Presence of comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Mean Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg) Baseline, Week 52 LS mean was determined using MMRM model with Baseline + Sex + Presence of comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Mean Change From Baseline in Triglycerides (Pooled Doses of Tirzepatide 10 mg and 15 mg) Baseline, Week 52 LS mean was determined using MMRM model using log (Actual Measurement) = log (Baseline) + Sex + Presence of comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Mean Change From Baseline in Fasting Insulin (Pooled Doses of Tirzepatide 10 mg and 15 mg) Baseline, Week 52 LS mean was determined using MMRM model with log (Actual Measurement) = log (Baseline) + Sex + Presence of comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Mean Change From Baseline in Waist Circumference Baseline, Week 52 Mean Change from Baseline in Waist Circumference. LS mean was determined using MMRM model with Baseline + Sex + Presence of comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Mean Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score Baseline, Week 52 The SF-36v2 acute form, 1-week recall assesses participants' health-related quality of life (HRQoL) on 8 domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Information from these 8 domains is further aggregated into 2 health component summary scores: Physical Component Summary and Mental Component Summary.
Items are answered on Likert scales of varying lengths. Scoring of each domain and both summary scores are norm based and presented in the form of T scores, with a mean of 50 and standard deviation of 10; higher scores indicate better levels of function and/or better health. Range cannot be specified in norm-based scores.
LS mean was determined using analysis of covariance (ANCOVA) model using Baseline + Sex + Presence of comorbidities + Treatment (Type III sum of squares) as variables.Mean Change From Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score Baseline, Week 52 The IWQOL Lite-CT consists of 20 items, assessing 2 primary domains of obesity related HRQoL: Physical (7 items) and Psychosocial (13 items). A 5-item subset of the Physical domain - the Physical Function composite - is also supported. Items in the Physical Function composite describe physical impacts related to general and specific physical activities. Total score of IWQOL-Lite-CT composite ranges from 0 to 100, with higher scores reflecting better quality of life. LS mean was determined using ANCOVA model with Baseline + Sex + Presence of comorbidities + Treatment (Type III sum of squares) as variables.
Mean Change From Baseline in Diastolic Blood Pressure (DBP) (Pooled Doses of Tirzepatide 10 mg and 15 mg) Baseline, Week 52 LS mean was determined using MMRM model with Variable = Baseline + Sex + Presence of comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Mean Change From Baseline in Hemoglobin A1c (HbA1c) Baseline, Week 52 Mean Change from Baseline in HbA1c. LS mean was determined using MMRM model with Baseline + Sex + Presence of comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Mean Change From Baseline in Fasting Glucose (FSG) Baseline, Week 52 Mean Change from Baseline in FSG. LS mean was determined using MMRM model with Baseline + Sex + Presence of comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Mean Change From Baseline in Total Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg) Baseline, Week 52 LS mean was determined using MMRM model using log (Actual measurement/Baseline) = log (Baseline) + Sex + Presence of comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Mean Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg) Baseline, Week 52 LS mean was determined using MMRM model using log (Actual Measurement) = log (Baseline) + Sex + Presence of comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Mean Change From Baseline in Body Mass Index (BMI) Baseline, Week 52 Mean Change from Baseline in BMI. LS mean was determined using MMRM model with Baseline + Sex + Presence of comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Mean Change From Baseline in Systolic Blood Pressure (SBP) (Pooled Doses of Tirzepatide 10 mg and 15 mg) Baseline, Week 52 LS mean was determined using MMRM model with Baseline + Sex + Presence of comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Mean Change From Baseline in Free Fatty Acids (Pooled Doses of Tirzepatide 10 mg and 15 mg) Baseline, Week 52 LS mean was determined using MMRM model using log (Actual Measurement) = log (Baseline) + Sex + Presence of comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Trial Locations
- Locations (29)
The Second Affiliated Hospital of Nanjing Medical University
🇨🇳Nanjing, Jiangsu, China
Zhujiang Hospital
🇨🇳Guangzhou, Guangdong, China
Beijing Tsinghua Changgung Hospital
🇨🇳Beijing, Beijing, China
The First Affiliated Hospital Chongqing Medical University
🇨🇳Chongqing, Chongqing, China
Shenzhen Second People's Hospital
🇨🇳Shenzhen, Guangdong, China
The First Hospital of Qinhuangdao
🇨🇳Qinhuangdao, Hebei, China
The First Affiliated Hospital of Henan University of Science &Technology
🇨🇳Luoyang, Henan, China
The Second Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
The First Affiliated Hospital of Nanhua University
🇨🇳Hengyang, Hunan, China
The Fourth Affiliated Hospital of Harbin Medical University
🇨🇳Harbin, Heilongjiang, China
Nanjing Medical University - Nanjing Jiangning Hospital
🇨🇳Nanjing, Jiangsu, China
Changzhou No.2 People's Hospital
🇨🇳Changzhou, Jiangsu, China
Affiliated Hospital of Nantong University
🇨🇳Nantong, Jiangsu, China
Wuxi People's Hospital
🇨🇳Wuxi, Jiangsu, China
The Second Hospital of Jilin University
🇨🇳Changchun, Jilin, China
Zhongshan Hospital, Fudan University
🇨🇳Shanghai, Shanghai, China
Siping Central People's Hospital
🇨🇳Siping, Jilin, China
Jinan Central Hospital
🇨🇳Jinan, Shandong, China
Huadong Hospital Affiliated to Fudan University
🇨🇳Shanghai, Shanghai, China
Shanghai Hospital of Traditional Chinese Medicine
🇨🇳Shanghai, Shanghai, China
The First Affiliated Hospital of Xi'an Medical University
🇨🇳Xi'an, Shanxi, China
Qingpu Branch of Zhongshan Hospital, Fudan University
🇨🇳Shanghai, Shanghai, China
West China Hospital of Sichuan University
🇨🇳Chengdu, Sichuan, China
Tianjin Medical University General Hospital
🇨🇳Tianjin, Tianjin, China
Huzhou Central Hospital
🇨🇳Huzhou, Zhejiang, China
The First People's Hospital of Hangzhou
🇨🇳Hangzhou, Zhejiang, China
Ningbo First Hospital
🇨🇳Ningbo, Zhejiang, China
The Fifth People's Hospital of Shanghai
🇨🇳Shanghai, China
Shanghai Minhang District Central Hospital
🇨🇳Shanghai, China