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A Study of Tirzepatide (LY3298176) in Chinese Participants Without Type 2 Diabetes Who Have Obesity or Overweight (SURMOUNT-CN)

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT05024032
Collaborator
(none)
210
Enrollment
29
Locations
3
Arms
15.3
Anticipated Duration (Months)
7.2
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
210 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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)
Actual Study Start Date :
Sep 1, 2021
Anticipated Primary Completion Date :
Nov 14, 2022
Anticipated Study Completion Date :
Dec 12, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Tirzepatide Dose 1

tirzepatide administered subcutaneously (SC) once a week.

Drug: Tirzepatide
Administered SC
Other Names:
  • LY3298176

    		•
    Experimental: Tirzepatide Dose 2

    tirzepatide administered SC once a week.

    Drug: Tirzepatide
    Administered SC
    Other Names:
  • LY3298176

    		•
    Placebo Comparator: Placebo

    placebo administered SC once a week.

    Drug: Placebo
    Administered SC

    Outcome Measures

    Primary Outcome Measures

    1. Mean Percent Change from Randomization in Body Weight [Randomization, Week 52]

      Mean Percent Change from Randomization in Body Weight

    2. Percentage of Participants who Achieve ≥5% Body Weight Reduction [Week 52]

      Percentage of Participants who Achieve ≥5% Body Weight Reduction

    Secondary Outcome Measures

    1. Mean Change from Randomization in Body Weight [Randomization, Week 20]

      Mean Change from Randomization in Body Weight

    2. Percentage of Participants who Achieve ≥10% Body Weight Reduction [Week 52]

      Percentage of Participants who Achieve ≥10% Body Weight Reduction

    3. Percentage of Participants who Achieve ≥15% Body Weight Reduction [Week 52]

      Percentage of Participants who Achieve ≥15% Body Weight Reduction

    4. Mean Change from Randomization in Waist Circumference [Randomization, Week 52]

      Mean Change from Randomization in Waist Circumference

    5. Mean Change from Randomization in Body Weight [Randomization, Week 52]

      Mean Change from Randomization in Body Weight

    6. Mean Change from Randomization in Body Mass Index (BMI) [Randomization, Week 52]

      Mean Change from Randomization in BMI

    7. Mean Change from Randomization in Hemoglobin A1c (HbA1c) [Randomization, Week 52]

      Mean Change from Randomization in HbA1c

    8. Mean Change from Randomization in Fasting Glucose (FSG) [Randomization, Week 52]

      Mean Change from Randomization in FSG

    9. Mean Change from Randomization in Short-Form-36 Health Survey Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score [Randomization, Week 52]

      The SF-36v2 acute form, 1-week recall assesses participants' health-related quality of life (HRQoL) on 8 domains; 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning 7) limitations in usual role due to emotional problems; and 8) general mental health. Domain scores are norm-based and presented in the form of T-scores, with a mean of 50 and standard deviation of 10, with higher scores indicating better levels of function and/or better health.

    10. Mean Change from Randomization in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score [Randomization, 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. Individual composite scale scores and a total score can be computed and are presented on a scale of 0 to 100, with higher scores indicating better function.

    11. Mean Change from Randomization in Diastolic Blood Pressure (DBP) [Randomization, Week 52]

      Mean Change from Randomization in DBP

    12. Mean Change from Randomization in Systolic Blood Pressure (SBP) [Randomization, Week 52]

      Mean Change from Randomization in SBP

    13. Mean Change from Randomization in Total Cholesterol [Randomization, Week 52]

      Mean Change from Randomization in Total Cholesterol

    14. Mean Change from Randomization in High Density Lipoprotein (HDL) Cholesterol [Randomization, Week 52]

      Mean Change from Randomization in HDL Cholesterol

    15. Mean Change from Randomization in Low Density Lipoprotein (LDL) Cholesterol [Randomization, Week 52]

      Mean Change from Randomization in LDL Cholesterol

    16. Mean Change from Randomization in Very Low Density Lipoprotein (VLDL) Cholesterol [Randomization, Week 52]

      Mean Change from Randomization in VLDL Cholesterol

    17. Mean Change from Randomization in Triglycerides [Randomization, Week 52]

      Mean Change from Randomization in Triglycerides

    18. Mean Change from Randomization in Free Fatty Acids [Randomization, Week 52]

      Mean Change from Randomization in Free Fatty Acids

    19. Mean Change from Randomization in Fasting Insulin [Randomization, Week 52]

      Mean Change from Randomization in Fasting Insulin

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beijing Tsinghua Changgung Hospital Beijing Beijing China 102202
    2 The First Affiliated Hospital Chongqing Medical University Chongqing Chongqing China 400016
    3 Zhujiang Hospital Guangzhou Guangdong China 510280
    4 Shenzhen Second People's Hospital Shenzhen Guangdong China 518039
    5 The First Hospital of Qinhuangdao Qinhuangdao Shi Hebei China 066000
    6 The Fourth Affiliated Hospital of Harbin Medical University Harbin Heilongjiang China 150001
    7 The First Affiliated Hospital of Henan University of Science &Technology Luoyang Shi Henan China 471003
    8 The Second Affiliated Hospital of Zhengzhou University Zhengzhou Henan China 450014
    9 The First Affiliated Hospital of Nanhua University Hengyang Hunan China 421001
    10 Changzhou No.2 People's Hospital Changzhou Jiangsu China 213000
    11 The Second Affiliated Hospital of Nanjing Medical University Nanjing Jiangsu China 210011
    12 Nanjing Medical University - Nanjing Jiangning Hospital Nanjing Jiangsu China 211100
    13 Affiliated Hospital of Nantong University Nantong Jiangsu China 226001
    14 Wuxi People's Hospital Wuxi Jiangsu China 214023
    15 The Second Hospital of Jilin University Changchun Jilin China
    16 Siping Central People's Hospital Siping Jilin China 136000
    17 Jinan Central Hospital Jinan Shandong China 250013
    18 Zhongshan Hospital, Fudan University Shanghai Shanghai China 200032
    19 Huadong Hospital Affiliated to Fudan University Shanghai Shanghai China 200040
    20 Shanghai Hospital of Traditional Chinese Medicine Shanghai Shanghai China 200071
    21 Qingpu Branch of Zhongshan Hospital, Fudan University Shanghai Shanghai China 201700
    22 The First Affiliated Hospital of Xi'an Medical University XI 'an Shanxi China 710077
    23 West China Hospital of Sichuan University Chengdu Sichuan China 610041
    24 Tianjin Medical University General Hospital Tianjin Tianjin China 300052
    25 The First People's Hospital of Hangzhou Hangzhou Zhejiang China 310006
    26 Huzhou Central Hospital Huzhou Zhejiang China 313000
    27 Ningbo First Hospital Ningbo Zhejiang China 315010
    28 The Fifth People's Hospital of Shanghai Shanghai China 200240
    29 Shanghai Minhang District Central Hospital Shanghai China 201199

    Sponsors and Collaborators

    • Eli Lilly and Company

    Investigators

    • Study Director: 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), Eli Lilly and Company

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT05024032
    Other Study ID Numbers:
    • 17507
    • I8F-MC-GPIA
    First Posted:
    Aug 27, 2021
    Last Update Posted:
    Aug 19, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Obesity
    Nutrition Disorders
    Overweight
    Tirzepatide

    Study Results

    No Results Posted as of Aug 19, 2022