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
Recruiting
CT.gov ID
NCT05024032
Collaborator
(none)
210
Enrollment
30
Locations
3
Arms
15.4
Anticipated Duration (Months)
7
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 DiseaseIntervention/TreatmentPhase
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 16, 2022
Anticipated Study Completion Date :
Dec 14, 2022

Arms and Interventions

ArmIntervention/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

    SiteCityStateCountryPostal Code
    1Beijing Tsinghua Changgung HospitalChangpingBeijingChina102202
    2The First Affiliated Hospital Chongqing Medical UniversityChongqingChongqingChina400016
    3Zhujiang HospitalGuangzhouGuangdongChina510280
    4Shenzhen Second People's HospitalShenzhenGuangdongChina518039
    5The First Hospital of QinhuangdaoQinhuangdao ShiHebeiChina066000
    6The Fourth Affiliated Hospital of Harbin Medical UniversityHarbinHeilongjiangChina150001
    7The First Affiliated Hospital of Henan University of Science &TechnologyLuoyang ShiHenanChina471003
    8The Second Affiliated Hospital of Zhengzhou UniversityZhengzhouHenanChina450014
    9The First Affiliated Hospital of Nanhua UniversityHengyangHunanChina421001
    10Changzhou No.2 People's HospitalChangzhouJiangsuChina213000
    11The Second Affiliated Hospital of Nanjing Medical UniversityNanjingJiangsuChina210011
    12Nanjing Medical University - Nanjing Jiangning HospitalNanjingJiangsuChina211100
    13Affiliated Hospital of Nantong UniversityNantongJiangsuChina226001
    14Wuxi People's HospitalWuxiJiangsuChina214023
    15The Second Hospital of Jilin UniversityChangchunJilinChina
    16Siping Central People's HospitalSipingJilinChina136000
    17Jinan Central HospitalJinanShandongChina250013
    18Zhongshan Hospital, Fudan UniversityShanghaiShanghaiChina200032
    19Huadong Hospital Affiliated to Fudan UniversityShanghaiShanghaiChina200040
    20Shanghai Hospital of Traditional Chinese MedicineShanghaiShanghaiChina200071
    21Qingpu Branch of Zhongshan Hospital, Fudan UniversityShanghaiShanghaiChina201700
    22The First Affiliated Hospital of Xi'an Medical UniversityXI 'anShanxiChina710077
    23West China Hospital Sichuan UniversityChengduSichuanChina610041
    24Tianjin Medical University General HospitalTianjinTianjinChina300052
    25The First People's Hospital of HangzhouHangzhouZhejiangChina310006
    26Huzhou Central HospitalHuzhouZhejiangChina313000
    27Ningbo First HospitalNingboZhejiangChina315010
    28Beijing Chao Yang HospitalBeijingChina100020
    29The Fifth People's Hospital of ShanghaiShanghaiChina200240
    30Shanghai Minhang District Central HospitalShanghaiChina201199

    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:
    Nov 18, 2021
    Last Verified:
    Nov 15, 2021
    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:

    Study Results

    No Results Posted as of Nov 18, 2021