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

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04844918
Collaborator
(none)
261
18
3
25.7
14.5
0.6

Study Details

Study Description

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
Phase 3

Study Design

Study Type:
Interventional
Anticipated 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
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Tirzepatide Regimen A

Tirzepatide Regimen A administered subcutaneously (SC)

Drug: Tirzepatide
Administered SC
Other Names:
  • LY3298176
  • Experimental: Tirzepatide Regimen B

    Tirzepatide Regimen B administered subcutaneously (SC)

    Drug: Tirzepatide
    Administered SC
    Other Names:
  • LY3298176
  • Placebo Comparator: Placebo

    Placebo administered SC

    Other: Placebo
    Administered SC

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants who Achieve ≥5% Body Weight Reduction [Week 72]

      Percentage of Participants Who Achieve ≥5% Body Weight Reduction

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

      Percent Change in Body Weight

    Secondary Outcome Measures

    1. Percentage of Participants Who Had Improvement in Obesity-related Health Problems [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) [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) [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) [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) [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) [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) [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) [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 [Week 72]

      Percentage of Participants Who Achieve ≥10% body weight reduction

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

      Percentage of Participants Who Achieve ≥15% body weight reduction

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

      Change from Baseline in Absolute Body Weight

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

      Change from Baseline in BMI

    13. Change from Baseline in Visceral Adipose Tissue (VAT) [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) [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 [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) [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 [Baseline, Week 72]

      Change from Baseline in Waist Circumference

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

      Change from Baseline in HbA1c

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

      Change from Baseline in Fasting Insulin

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

      Change from Baseline in Systolic Blood Pressure

    21. Change from Baseline in Diastolic Blood Pressure [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 [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 [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) [Baseline, Week 72]

      Change from Baseline in Euro Quality of Life Five Dimensions (EQ-5D-5L)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kohnodai Hospital, National Center for Global Health and Medicine Ichikawa Chiba Japan 272-8516
    2 Saiseikai Matsuyama Hospital Matsuyama Ehime Japan 791-8026
    3 Takai Internal Medicine Clinic Kamakura-shi Kanagawa Japan 247-0056
    4 Motomachi Takatsuka Naika Clinic Yokohama-city Kanagawa Japan 231-0023
    5 Saiseikai Yokohamashi Tobu Hospital Yokohama Kanagawa Japan 2308765
    6 Medical Corporation Heishinkai OCROM Clinic Suita-shi Osaka Japan 565-0853
    7 Osaka Saiseikai Suita hospital Suita Osaka Japan 564-0013
    8 Takatsuki Red Cross Hospital Takatsuki Osaka Japan 569-1045
    9 The Institute for Adult Disease, Asahi Life Foundation Chuo-ku Tokyo Japan 103-0002
    10 Tokyo-Eki Center-building Clinic Chuo-ku Tokyo Japan 103-0027
    11 Medical Corporation Chiseikai Tokyo Center Clinic Chuo-ku Tokyo Japan 103-0028
    12 Fukuwa Clinic Chuo-ku Tokyo Japan 104-0031
    13 Saiseikai Central Hospital Minato-Ku Tokyo Japan 108-0073
    14 Shimokitazawa Tomo Clinic Setagaya-ku Tokyo Japan 155-0031
    15 Miho Clinic Shinagawa-ku Tokyo Japan 141 0032
    16 Medical Corporation Heishinkai ToCROM Clinic Shinjuku-ku Tokyo Japan 160 0008
    17 Yamagata Tokushukai Hospital Yamagata-shi Yamagata Japan 990-0834
    18 AMC Nishiumeda Clinic Osaka Japan 530-0001

    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:
    NCT04844918
    Other Study ID Numbers:
    • 17506
    • I8F-JE-GPHZ
    First Posted:
    Apr 14, 2021
    Last Update Posted:
    Feb 7, 2022
    Last Verified:
    Feb 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
    Keywords provided by Eli Lilly and Company
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 7, 2022