SURMOUNT-J: A Study of Tirzepatide (LY3298176) in Participants With Obesity Disease
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
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Tirzepatide Regimen A Tirzepatide Regimen A administered subcutaneously (SC) |
Drug: Tirzepatide
Administered SC
Other Names:
|
Experimental: Tirzepatide Regimen B Tirzepatide Regimen B administered subcutaneously (SC) |
Drug: Tirzepatide
Administered SC
Other Names:
|
Placebo Comparator: Placebo Placebo administered SC |
Other: Placebo
Administered SC
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants who Achieve ≥5% Body Weight Reduction [Week 72]
Percentage of Participants Who Achieve ≥5% Body Weight Reduction
- Percent Change in Body Weight [Baseline, 72 Weeks]
Percent Change in Body Weight
Secondary Outcome Measures
- 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
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- Percentage of Participants Who Achieve ≥10% body weight reduction [Week 72]
Percentage of Participants Who Achieve ≥10% body weight reduction
- Percentage of Participants Who Achieve ≥15% body weight reduction [Week 72]
Percentage of Participants Who Achieve ≥15% body weight reduction
- Change from Baseline in Absolute Body Weight [Baseline, Week 72]
Change from Baseline in Absolute Body Weight
- Change from Baseline in BMI [Baseline, Week 72]
Change from Baseline in BMI
- 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).
- 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.
- Change from Baseline in VAT/SAT Ratio [Baseline, Week 72]
Change from Baseline in VAT/SAT Ratio
- 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)
- Change from Baseline in Waist Circumference [Baseline, Week 72]
Change from Baseline in Waist Circumference
- Change from Baseline in Hemoglobin A1c (HbA1c) [Baseline, Week 72]
Change from Baseline in HbA1c
- Change from Baseline in Fasting Insulin [Baseline, Week 72]
Change from Baseline in Fasting Insulin
- Change from Baseline in Systolic Blood Pressure [Baseline, Week 72]
Change from Baseline in Systolic Blood Pressure
- Change from Baseline in Diastolic Blood Pressure [Baseline, Week 72]
Change from Baseline in Diastolic Blood Pressure
- 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
- 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
- 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
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.- 17506
- I8F-JE-GPHZ