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

Obesity Clinical Trial

— SURMOUNT-J  

Official title:

Efficacy and Safety of Once-Weekly Tirzepatide in Participants With Obesity Disease: A Randomized, Double-Blind, Placebo-Controlled Trial (SURMOUNT-J)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04844918
• Other study ID #: 17506
• Secondary ID: I8F-JE-GPHZ
• Status: Completed
• Phase: Phase 3
• Start date: May 10, 2021
• Est. completion date: June 24, 2023

Study information

• Verified date: August 2023
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 267
• Est. completion date: June 24, 2023
• Est. primary completion date: June 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Obesity

Intervention

Drug:
• Tirzepatide
Administered SC

Other:
• Placebo
Administered SC

Locations

Country	Name	City	State
Japan	Fukuwa Clinic	Chuo-ku	Tokyo
Japan	Medical Corporation Chiseikai Tokyo Center Clinic	Chuo-ku	Tokyo
Japan	The Institute for Adult Disease, Asahi Life Foundation	Chuo-ku	Tokyo
Japan	Tokyo-Eki Center-building Clinic	Chuo-ku	Tokyo
Japan	Kohnodai Hospital, National Center for Global Health and Medicine	Ichikawa	Chiba
Japan	Takai Internal Medicine Clinic	Kamakura-shi	Kanagawa
Japan	Saiseikai Matsuyama Hospital	Matsuyama	Ehime
Japan	Saiseikai Central Hospital	Minato-Ku	Tokyo
Japan	AMC Nishiumeda Clinic	Osaka
Japan	Shimokitazawa Tomo Clinic	Setagaya-ku	Tokyo
Japan	Miho Clinic	Shinagawa-ku	Tokyo
Japan	Medical Corporation Heishinkai ToCROM Clinic	Shinjuku-ku	Tokyo
Japan	Osaka Saiseikai Suita hospital	Suita	Osaka
Japan	Medical Corporation Heishinkai OCROM Clinic	Suita-shi	Osaka
Japan	Takatsuki Red Cross Hospital	Takatsuki	Osaka
Japan	Yamagata Tokushukai Hospital	Yamagata-shi	Yamagata
Japan	Saiseikai Yokohamashi Tobu Hospital	Yokohama	Kanagawa
Japan	Motomachi Takatsuka Naika Clinic	Yokohama-city	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants who Achieve =5% Body Weight Reduction	Percentage of Participants Who Achieve =5% Body Weight Reduction	Week 72
Primary	Percent Change in Body Weight	Percent Change in Body Weight	Baseline, 72 Weeks
Secondary	Percentage of Participants Who Had Improvement in Obesity-related Health Problems	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	Week 72
Secondary	Change from Baseline in Oral Glucose Tolerance (OGTT) 2-hr Glucose (Only for Participant with Impaired Glucose Tolerance [IGT] at Baseline)	Change from Baseline in OGTT 2-hr Glucose (Only for Participants with IGT at Baseline)	Baseline, Week 72
Secondary	Change from Baseline in Fasting Glucose (Only for Participants with IGT at Baseline)	Change from Baseline in Fasting Glucose (Only for Participants with IGT at Baseline)	Baseline, Week 72
Secondary	Change from Baseline in Fasting Lipids [Triglycerides (TG)] (Only for Participants with hyperlipidemia at Baseline)	Change from Baseline in Fasting Lipids TG (Only for Participants with hyperlipidemia at Baseline)	Baseline, Week 72
Secondary	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)	Change from Baseline in HFF (only for participants diagnosed as NAFLD by MRI at Baseline)	Baseline, Week 72
Secondary	Percentage of Participants Who Achieved Improvements of IGT (Only for Participants with IGT at Baseline)	Percentage of Participants Who Achieved Improvements of IGT (Only for Participants with IGT at Baseline)	Week 72
Secondary	Percentage of Participants Who Achieved Improvements of Hyperlipidemia (Only for Participants with Hyperlipidemia at Baseline)	Percentage of Participants Who Achieved Improvements of Hyperlipidemia (only for participants with hyperlipidemia at Baseline)	Week 72
Secondary	Percentage of Participants Who Achieved Improvements of NAFLD (only for participants who are diagnosed as NAFLD by Magnetic Resonance Imaging (MRI) at Baseline)	Percentage of Participants Who Achieved Improvements of NAFLD (only for participants who are diagnosed as NAFLD by MRI at Baseline)	Week 72
Secondary	Percentage of Participants Who Achieve =10% body weight reduction	Percentage of Participants Who Achieve =10% body weight reduction	Week 72
Secondary	Percentage of Participants Who Achieve =15% body weight reduction	Percentage of Participants Who Achieve =15% body weight reduction	Week 72
Secondary	Change from Baseline in Absolute Body Weight	Change from Baseline in Absolute Body Weight	Baseline, Week 72
Secondary	Change from Baseline in BMI	Change from Baseline in BMI	Baseline, Week 72
Secondary	Change from Baseline in Visceral Adipose Tissue (VAT)	Change from Baseline in VAT will be collected by single slice imaging at the umbilicus level in a supine position using computerized tomography (CT).	Baseline, Week 72
Secondary	Change from Baseline in Subcutaneous Adipose Tissue (SAT)	Change from Baseline in SAT will be collected by single slice imaging at the umbilicus level in a supine position using CT.	Baseline, Week 72
Secondary	Change from Baseline in VAT/SAT Ratio	Change from Baseline in VAT/SAT Ratio	Baseline, Week 72
Secondary	Percentage of Participants Who Achieve VAT <100 square centimeter (cm²) from Baseline (only for participants with VAT=100 cm2 at Baseline)	Percentage of Participants Who Achieve VAT <100 cm² from Baseline (only for participants with VAT=100 cm2 at Baseline)	Week 72
Secondary	Change from Baseline in Waist Circumference	Change from Baseline in Waist Circumference	Baseline, Week 72
Secondary	Change from Baseline in Hemoglobin A1c (HbA1c)	Change from Baseline in HbA1c	Baseline, Week 72
Secondary	Change from Baseline in Fasting Insulin	Change from Baseline in Fasting Insulin	Baseline, Week 72
Secondary	Change from Baseline in Systolic Blood Pressure	Change from Baseline in Systolic Blood Pressure	Baseline, Week 72
Secondary	Change from Baseline in Diastolic Blood Pressure	Change from Baseline in Diastolic Blood Pressure	Baseline, Week 72
Secondary	Change from Baseline in Short Form 36 Version 2 Health Survey (SF-36v2) Acute Form Physical Functioning Domain Score	Change from Baseline in SF-36v2 Acute Form Physical Functioning Domain Score	Baseline, Week 72
Secondary	Change from Baseline in Change in Impact of Weight on Quality-of-Life Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score	Change from Baseline in Change in IWQOL-Lite-CT Physical Function score	Baseline, Week 72
Secondary	Change from Baseline in Euro Quality of Life Five Dimensions (EQ-5D-5L)	Change from Baseline in Euro Quality of Life Five Dimensions (EQ-5D-5L)	Baseline, Week 72