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

• ClinicalTrials.gov Identifier: NCT04844918
• Recruitment Status: Active, not recruiting
• First Posted: April 14, 2021
• Last Update Posted: March 15, 2023
• Sponsor: Eli Lilly and Company
• Information provided by (Responsible Party): Eli Lilly and Company

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
Obesity	Drug: Tirzepatide; Other: Placebo	Phase 3

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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)

Eligibility Criteria

• 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.

Contacts and Locations

Locations

Japan

Kohnodai Hospital, National Center for Global Health and Medicine

Ichikawa, Chiba, Japan, 272-8516

Saiseikai Matsuyama Hospital

Matsuyama, Ehime, Japan, 791-8026

Takai Internal Medicine Clinic

Kamakura-shi, Kanagawa, Japan, 247-0056

Motomachi Takatsuka Naika Clinic

Yokohama-city, Kanagawa, Japan, 231-0023

Saiseikai Yokohamashi Tobu Hospital

Yokohama, Kanagawa, Japan, 2308765

Medical Corporation Heishinkai OCROM Clinic

Suita-shi, Osaka, Japan, 565-0853

Osaka Saiseikai Suita hospital

Suita, Osaka, Japan, 564-0013

Takatsuki Red Cross Hospital

Takatsuki, Osaka, Japan, 569-1045

The Institute for Adult Disease, Asahi Life Foundation

Chuo-ku, Tokyo, Japan, 103-0002

Tokyo-Eki Center-building Clinic

Chuo-ku, Tokyo, Japan, 103-0027

Medical Corporation Chiseikai Tokyo Center Clinic

Chuo-ku, Tokyo, Japan, 103-0028

Fukuwa Clinic

Chuo-ku, Tokyo, Japan, 104-0031

Saiseikai Central Hospital

Minato-Ku, Tokyo, Japan, 108-0073

Shimokitazawa Tomo Clinic

Setagaya-ku, Tokyo, Japan, 155-0031

Miho Clinic

Shinagawa-ku, Tokyo, Japan, 141 0032

Medical Corporation Heishinkai ToCROM Clinic

Shinjuku-ku, Tokyo, Japan, 160 0008

Yamagata Tokushukai Hospital

Yamagata-shi, Yamagata, Japan, 990-0834

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

More Information

• 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
• Last Update Posted: March 15, 2023
• Last Verified: March 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: https://vivli.org/

• 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:

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