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A Study of Tirzepatide (LY3298176) in Participants With Obesity Disease (SURMOUNT-J)

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: NCT04844918
Recruitment Status : Active, not recruiting
First Posted : April 14, 2021
Last Update Posted : February 7, 2022
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The main purpose of this study is to learn more about tirzepatide in participants with obesity disease. The study will also measure how Tirzepatide affects body weight with a low-calorie diet and increased physical activity. The study will last around 72 Weeks.

Condition or disease Intervention/treatment Phase
Obesity Drug: Tirzepatide Other: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 261 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Once-Weekly Tirzepatide in Participants With Obesity Disease: A Randomized, Double-Blind, Placebo-Controlled Trial (SURMOUNT-J)
Actual Study Start Date : May 10, 2021
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : June 30, 2023

Arm Intervention/treatment
Experimental: Tirzepatide Regimen A
Tirzepatide Regimen A administered subcutaneously (SC)
Drug: Tirzepatide
Administered SC
Other Name: LY3298176

Experimental: Tirzepatide Regimen B
Tirzepatide Regimen B administered subcutaneously (SC)
Drug: Tirzepatide
Administered SC
Other Name: LY3298176

Placebo Comparator: Placebo
Placebo administered SC
Other: Placebo
Administered SC




Primary Outcome Measures :
  1. Percentage of Participants who Achieve ≥5% Body Weight Reduction [ Time Frame: Week 72 ]
    Percentage of Participants Who Achieve ≥5% Body Weight Reduction

  2. Percent Change in Body Weight [ Time Frame: Baseline, 72 Weeks ]
    Percent Change in Body Weight


Secondary Outcome Measures :
  1. Percentage of Participants Who Had Improvement in Obesity-related Health Problems [ Time Frame: Week 72 ]
    Percentage of participants who had improvement in at least 2 obesity-related health problems in participants with a baseline body mass index (BMI) ≥27 and <35 kilogram per square meter (kg/m²) or improvement in at least 1 obesity-related health problems in participants with a baseline BMI ≥35 kg/m²

  2. Change from Baseline in Oral Glucose Tolerance (OGTT) 2-hr Glucose (Only for Participant with Impaired Glucose Tolerance [IGT] at Baseline) [ Time Frame: Baseline, Week 72 ]
    Change from Baseline in OGTT 2-hr Glucose (Only for Participants with IGT at Baseline)

  3. Change from Baseline in Fasting Glucose (Only for Participants with IGT at Baseline) [ Time Frame: Baseline, Week 72 ]
    Change from Baseline in Fasting Glucose (Only for Participants with IGT at Baseline)

  4. Change from Baseline in Fasting Lipids [Triglycerides (TG)] (Only for Participants with hyperlipidemia at Baseline) [ Time Frame: Baseline, Week 72 ]
    Change from Baseline in Fasting Lipids TG (Only for Participants with hyperlipidemia at Baseline)

  5. Change from Baseline in Hepatic Fat Fraction (HFF) (only for participants diagnosed as Non-alcoholic Fatty Liver Disease [NAFLD] by Magnetic Resonance Imaging (MRI) at Baseline) [ Time Frame: Baseline, Week 72 ]
    Change from Baseline in HFF (only for participants diagnosed as NAFLD by MRI at Baseline)

  6. Percentage of Participants Who Achieved Improvements of IGT (Only for Participants with IGT at Baseline) [ Time Frame: Week 72 ]
    Percentage of Participants Who Achieved Improvements of IGT (Only for Participants with IGT at Baseline)

  7. Percentage of Participants Who Achieved Improvements of Hyperlipidemia (Only for Participants with Hyperlipidemia at Baseline) [ Time Frame: Week 72 ]
    Percentage of Participants Who Achieved Improvements of Hyperlipidemia (only for participants with hyperlipidemia at Baseline)

  8. Percentage of Participants Who Achieved Improvements of NAFLD (only for participants who are diagnosed as NAFLD by Magnetic Resonance Imaging (MRI) at Baseline) [ Time Frame: Week 72 ]
    Percentage of Participants Who Achieved Improvements of NAFLD (only for participants who are diagnosed as NAFLD by MRI at Baseline)

  9. Percentage of Participants Who Achieve ≥10% body weight reduction [ Time Frame: Week 72 ]
    Percentage of Participants Who Achieve ≥10% body weight reduction

  10. Percentage of Participants Who Achieve ≥15% body weight reduction [ Time Frame: Week 72 ]
    Percentage of Participants Who Achieve ≥15% body weight reduction

  11. Change from Baseline in Absolute Body Weight [ Time Frame: Baseline, Week 72 ]
    Change from Baseline in Absolute Body Weight

  12. Change from Baseline in BMI [ Time Frame: Baseline, Week 72 ]
    Change from Baseline in BMI

  13. Change from Baseline in Visceral Adipose Tissue (VAT) [ Time Frame: Baseline, Week 72 ]
    Change from Baseline in VAT will be collected by single slice imaging at the umbilicus level in a supine position using computerized tomography (CT).

  14. Change from Baseline in Subcutaneous Adipose Tissue (SAT) [ Time Frame: Baseline, Week 72 ]
    Change from Baseline in SAT will be collected by single slice imaging at the umbilicus level in a supine position using CT.

  15. Change from Baseline in VAT/SAT Ratio [ Time Frame: Baseline, Week 72 ]
    Change from Baseline in VAT/SAT Ratio

  16. Percentage of Participants Who Achieve VAT <100 square centimeter (cm²) from Baseline (only for participants with VAT≥100 cm2 at Baseline) [ Time Frame: Week 72 ]
    Percentage of Participants Who Achieve VAT <100 cm² from Baseline (only for participants with VAT≥100 cm2 at Baseline)

  17. Change from Baseline in Waist Circumference [ Time Frame: Baseline, Week 72 ]
    Change from Baseline in Waist Circumference

  18. Change from Baseline in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, Week 72 ]
    Change from Baseline in HbA1c

  19. Change from Baseline in Fasting Insulin [ Time Frame: Baseline, Week 72 ]
    Change from Baseline in Fasting Insulin

  20. Change from Baseline in Systolic Blood Pressure [ Time Frame: Baseline, Week 72 ]
    Change from Baseline in Systolic Blood Pressure

  21. Change from Baseline in Diastolic Blood Pressure [ Time Frame: Baseline, Week 72 ]
    Change from Baseline in Diastolic Blood Pressure

  22. Change from Baseline in Short Form 36 Version 2 Health Survey (SF-36v2) Acute Form Physical Functioning Domain Score [ Time Frame: Baseline, Week 72 ]
    Change from Baseline in SF-36v2 Acute Form Physical Functioning Domain Score

  23. Change from Baseline in Change in Impact of Weight on Quality-of-Life Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score [ Time Frame: Baseline, Week 72 ]
    Change from Baseline in Change in IWQOL-Lite-CT Physical Function score

  24. Change from Baseline in Euro Quality of Life Five Dimensions (EQ-5D-5L) [ Time Frame: Baseline, Week 72 ]
    Change from Baseline in Euro Quality of Life Five Dimensions (EQ-5D-5L)



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:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have a BMI of greater than or equal to ≥27 kg/m² and <less than 35 kg/m² with at least 2 obesity-related health problems or ≥35 kg/m² with at least 1 obesity-related health problems. Health problems are IGT, hyperlipidemia, or NAFLD.
  • Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.

Exclusion Criteria:

  • Have diabetes.
  • Acute or chronic liver disease other than NAFLD.
  • Have a self-reported change in body weight >5 kg within 3 months prior to screening.
  • Have or plan to have endoscopic and/or device-based therapy for obesity or have had device removal within the last 6 months.
  • Have renal impairment measured as estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2, calculated by Japanese Society of Nephrology coefficient-modified Chronic Kidney Disease-Epidemiology equation during screening.
  • Have a known clinically significant gastric emptying abnormality.
  • Have had a history of chronic or acute pancreatitis.
  • Have thyroid-stimulating hormone outside of the range of 0.4 to 6.0 micro units per milliliter (μIU/mL) at screening.
  • Have obesity induced by other endocrinologic disorders or diagnosed monogenetic or syndromic forms of obesity.
  • Have a history of significant active or unstable major depressive disorder or other severe psychiatric disorder within the last 2 years.
  • Have a cardiovascular condition within 3 months prior to randomization
  • Have a family or personal history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia Syndrome type 2.

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): NCT04844918


Locations
Show Show 18 study locations
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
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT04844918    
Other Study ID Numbers: 17506
I8F-JE-GPHZ ( Other Identifier: Eli Lilly and Company )
First Posted: April 14, 2021    Key Record Dates
Last Update Posted: February 7, 2022
Last Verified: February 1, 2022
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: https://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
Keywords provided by Eli Lilly and Company:
Metabolism and Nutrition Disorder
Obesity Related Health Problems
Obesity Disease
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Tirzepatide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists