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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05024032
Recruitment Status : Completed
First Posted : August 27, 2021
Last Update Posted : January 19, 2023
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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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
Obesity Overweight Metabolism and Nutrition Disorder Drug: Tirzepatide Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual 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 : September 1, 2021
Actual Primary Completion Date : December 27, 2022
Actual Study Completion Date : December 27, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight
Drug Information available for: Tirzepatide

Arms and Interventions
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Arm Intervention/treatment
Experimental: Tirzepatide Dose 1
tirzepatide administered subcutaneously (SC) once a week.
 Drug: Tirzepatide
Administered SC
Other Name: LY3298176
Experimental: Tirzepatide Dose 2
tirzepatide administered SC once a week.
 Drug: Tirzepatide
Administered SC
Other Name: LY3298176
Placebo Comparator: Placebo
placebo administered SC once a week.
 Drug: Placebo
Administered SC


Outcome Measures
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Primary Outcome Measures :
  1. Mean Percent Change from Randomization in Body Weight [ Time Frame: Randomization, Week 52 ]
    Mean Percent Change from Randomization in Body Weight

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


Secondary Outcome Measures :
  1. Mean Change from Randomization in Body Weight [ Time Frame: Randomization, Week 20 ]
    Mean Change from Randomization in Body Weight

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05024032


Locations
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Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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
More Information
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT05024032    
Other Study ID Numbers: 17507
I8F-MC-GPIA ( Other Identifier: Eli Lilly and Company )
First Posted: August 27, 2021    Key Record Dates
Last Update Posted: January 19, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: http://vivli.org/

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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:
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Obesity
Overweight
Nutrition Disorders
Overnutrition
Body Weight
Tirzepatide
 Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists