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

• ClinicalTrials.gov Identifier: NCT05024032
• Recruitment Status: Completed
• First Posted: August 27, 2021
• Last Update Posted: January 19, 2023
• Sponsor: Eli Lilly and Company
• Information provided by (Responsible Party): Eli Lilly and Company

Tracking Information

• First Submitted Date: August 25, 2021
• First Posted Date: August 27, 2021
• Last Update Posted Date: January 19, 2023
• Actual Study Start Date: September 1, 2021
• Actual Primary Completion Date: December 27, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 25, 2021)

• Mean Percent Change from Randomization in Body Weight [ Time Frame: Randomization, Week 52 ]
  Mean Percent Change from Randomization in Body Weight
• Percentage of Participants who Achieve ≥5% Body Weight Reduction [ Time Frame: Week 52 ]
  Percentage of Participants who Achieve ≥5% Body Weight Reduction

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 31, 2021)

• Mean Change from Randomization in Body Weight [ Time Frame: Randomization, Week 20 ]
  Mean Change from Randomization in Body Weight
• Percentage of Participants who Achieve ≥10% Body Weight Reduction [ Time Frame: Week 52 ]
  Percentage of Participants who Achieve ≥10% Body Weight Reduction
• Percentage of Participants who Achieve ≥15% Body Weight Reduction [ Time Frame: Week 52 ]
  Percentage of Participants who Achieve ≥15% Body Weight Reduction
• Mean Change from Randomization in Waist Circumference [ Time Frame: Randomization, Week 52 ]
  Mean Change from Randomization in Waist Circumference
• Mean Change from Randomization in Body Weight [ Time Frame: Randomization, Week 52 ]
  Mean Change from Randomization in Body Weight
• Mean Change from Randomization in Body Mass Index (BMI) [ Time Frame: Randomization, Week 52 ]
  Mean Change from Randomization in BMI
• Mean Change from Randomization in Hemoglobin A1c (HbA1c) [ Time Frame: Randomization, Week 52 ]
  Mean Change from Randomization in HbA1c
• Mean Change from Randomization in Fasting Glucose (FSG) [ Time Frame: Randomization, Week 52 ]
  Mean Change from Randomization in FSG
• 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.
• 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.
• Mean Change from Randomization in Diastolic Blood Pressure (DBP) [ Time Frame: Randomization, Week 52 ]
  Mean Change from Randomization in DBP
• Mean Change from Randomization in Systolic Blood Pressure (SBP) [ Time Frame: Randomization, Week 52 ]
  Mean Change from Randomization in SBP
• Mean Change from Randomization in Total Cholesterol [ Time Frame: Randomization, Week 52 ]
  Mean Change from Randomization in Total Cholesterol
• Mean Change from Randomization in High Density Lipoprotein (HDL) Cholesterol [ Time Frame: Randomization, Week 52 ]
  Mean Change from Randomization in HDL Cholesterol
• Mean Change from Randomization in Low Density Lipoprotein (LDL) Cholesterol [ Time Frame: Randomization, Week 52 ]
  Mean Change from Randomization in LDL Cholesterol
• Mean Change from Randomization in Very Low Density Lipoprotein (VLDL) Cholesterol [ Time Frame: Randomization, Week 52 ]
  Mean Change from Randomization in VLDL Cholesterol
• Mean Change from Randomization in Triglycerides [ Time Frame: Randomization, Week 52 ]
  Mean Change from Randomization in Triglycerides
• Mean Change from Randomization in Free Fatty Acids [ Time Frame: Randomization, Week 52 ]
  Mean Change from Randomization in Free Fatty Acids
• Mean Change from Randomization in Fasting Insulin [ Time Frame: Randomization, Week 52 ]
  Mean Change from Randomization in Fasting Insulin

Original Secondary Outcome Measures (submitted: August 25, 2021)

• Mean Change from Randomization in Body Weight [ Time Frame: Randomization, Week 20 ]
  Mean Change from Randomization in Body Weight
• Percentage of Participants who Achieve ≥10% Body Weight Reduction [ Time Frame: Week 52 ]
  Percentage of Participants who Achieve ≥10% Body Weight Reduction
• Percentage of Participants who Achieve ≥15% Body Weight Reduction [ Time Frame: Week 52 ]
  Percentage of Participants who Achieve ≥15% Body Weight Reduction
• Mean Change from Randomization in Waist Circumference [ Time Frame: Randomization, Week 52 ]
  Mean Change from Randomization in Waist Circumference
• Mean Change from Randomization in Body Weight [ Time Frame: Randomization, Week 52 ]
  Mean Change from Randomization in Body Weight
• Mean Change from Randomization in Body Mass Index (BMI) [ Time Frame: Randomization, Week 52 ]
  Mean Change from Randomization in BMI
• Mean Change from Randomization in Hemoglobin A1c (HbA1c) [ Time Frame: Randomization, Week 52 ]
  Mean Change from Randomization in HbA1c
• Mean Change from Randomization in Fasting Glucose (FSG) [ Time Frame: Randomization, Week 52 ]
  Mean Change from Randomization in FSG
• 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 ]
  Mean Change from Randomization in SF-36v2 Acute Form Physical Functioning Domain Score
• 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 ]
  Mean Change from Randomization in IWQOL-Lite-CT Physical Function Composite Score
• Mean Change from Randomization in Diastolic Blood Pressure (DBP) [ Time Frame: Randomization, Week 52 ]
  Mean Change from Randomization in DBP
• Mean Change from Randomization in Systolic Blood Pressure (SBP) [ Time Frame: Randomization, Week 52 ]
  Mean Change from Randomization in SBP
• Mean Change from Randomization in Total Cholesterol [ Time Frame: Randomization, Week 52 ]
  Mean Change from Randomization in Total Cholesterol
• Mean Change from Randomization in High Density Lipoprotein (HDL) Cholesterol [ Time Frame: Randomization, Week 52 ]
  Mean Change from Randomization in HDL Cholesterol
• Mean Change from Randomization in Low Density Lipoprotein (LDL) Cholesterol [ Time Frame: Randomization, Week 52 ]
  Mean Change from Randomization in LDL Cholesterol
• Mean Change from Randomization in Very Low Density Lipoprotein (VLDL) Cholesterol [ Time Frame: Randomization, Week 52 ]
  Mean Change from Randomization in VLDL Cholesterol
• Mean Change from Randomization in Triglycerides [ Time Frame: Randomization, Week 52 ]
  Mean Change from Randomization in Triglycerides
• Mean Change from Randomization in Free Fatty Acids [ Time Frame: Randomization, Week 52 ]
  Mean Change from Randomization in Free Fatty Acids
• Mean Change from Randomization in Fasting Insulin [ Time Frame: Randomization, Week 52 ]
  Mean Change from Randomization in Fasting Insulin

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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)

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 Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment

Condition

• Obesity
• Overweight
• Metabolism and Nutrition Disorder

Intervention

• Drug: Tirzepatide
  Administered SC
  Other Name: LY3298176
• Drug: Placebo
  Administered SC

Study Arms

• Experimental: Tirzepatide Dose 1
  tirzepatide administered subcutaneously (SC) once a week.
  Intervention: Drug: Tirzepatide
• Experimental: Tirzepatide Dose 2
  tirzepatide administered SC once a week.
  Intervention: Drug: Tirzepatide
• Placebo Comparator: Placebo
  placebo administered SC once a week.
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 25, 2021): 210
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: December 27, 2022
• Actual Primary Completion Date: December 27, 2022 (Final data collection date for primary outcome measure)

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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT05024032
• Other Study ID Numbers: 17507; I8F-MC-GPIA ( Other Identifier: Eli Lilly and Company )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• 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

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
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: 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/

• Current Responsible Party: Eli Lilly and Company
• Original Responsible Party: Same as current
• Current Study Sponsor: Eli Lilly and Company
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

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

• PRS Account: Eli Lilly and Company
• Verification Date: January 2023