Clinical trial NCT04844918: A Study of Tirzepatide (LY3298176) in Participants With Obesity Disease
Official title: Efficacy and Safety of Once-Weekly Tirzepatide in Participants With Obesity Disease: A Randomized, Double-Blind, Placebo-Controlled Trial (SURMOUNT-J)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obesity
Keywords: Metabolism and Nutrition Disorder
Obesity Related Health Problems
Obesity Disease
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2021-04-14
Enrollment: 267
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Mean Percent Change in Body Weight
timeFrame: Baseline, 72 Weeks
measure: Percentage of Participants Who Achieve ≥5% Body Weight Reduction
timeFrame: Week 72
Secondary outcomes:
measure: Percentage of Participants Who Had Improvement in Obesity-related Health Problems
timeFrame: Week 72
measure: Change From Baseline in Fasting Glucose for Participants With IGT at Baseline
timeFrame: Baseline, Week 72
measure: Change From Baseline in Oral Glucose Tolerance (OGTT) 2-hr Glucose for Participants With Impaired Glucose Tolerance (IGT) at Baseline
timeFrame: Baseline, Week 72
measure: Percent Change From Baseline in Fasting Lipids [Triglycerides (TG)] for Participants With Hyperlipidemia at Baseline
timeFrame: Baseline, Week 72
measure: Percent Change From Baseline in Hepatic Fat Fraction (HFF) for Participants With Non-alcoholic Fatty Liver Disease [NAFLD]
timeFrame: Baseline, Week 72
measure: Percentage of Participants Who Achieved Improvements of IGT
timeFrame: Week 72
measure: Percentage of Participants Who Achieved Improvements of Hyperlipidemia
timeFrame: Week 72
measure: Percentage of Participants Who Achieved Improvements of NAFLD
timeFrame: Week 72
measure: Percentage of Participants Who Achieve ≥10% Body Weight Reduction
timeFrame: Week 72
measure: Percentage of Participants Who Achieve ≥15% Body Weight Reduction
timeFrame: Week 72
measure: Change From Baseline in Absolute Body Weight
timeFrame: Baseline, Week 72
measure: Change From Baseline in Body Mass Index (BMI)
timeFrame: Baseline, Week 72
measure: Percent Change From Baseline in Visceral Adipose Tissue (VAT)
timeFrame: Baseline, Week 72
measure: Percent Change From Baseline in Subcutaneous Adipose Tissue (SAT)
timeFrame: Baseline, Week 72
measure: Change From Baseline in VAT/SAT Ratio
timeFrame: Baseline, Week 72
measure: Percentage of Participants Who Achieved VAT <100 Square Centimeter (cm²) From Baseline for Participants With VAT≥100 cm² at Baseline
timeFrame: Week 72
measure: Change From Baseline in Waist Circumference
timeFrame: Baseline, Week 72
measure: Change From Baseline in Hemoglobin A1c (HbA1c)
timeFrame: Baseline, Week 72
measure: Change From Baseline in Fasting Insulin for Participants With IGT at Baseline
timeFrame: Baseline, Week 72
measure: Change From Baseline in Systolic Blood Pressure
timeFrame: Baseline, Week 72
measure: Change From Baseline in Diastolic Blood Pressure
timeFrame: Baseline, Week 72
measure: Change From Baseline in Short Form 36 Version 2 Health Survey (SF-36v2) Acute Form Physical Functioning Domain Score
timeFrame: Baseline, Week 72
measure: Change From Baseline in Impact of Weight on Quality-of-Life Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score
timeFrame: Baseline, Week 72
measure: Change From Baseline in Euro Quality of Life Five Dimensions (EQ-5D-5L)
timeFrame: Baseline, Week 72
Other outcomes:
Locations:
city: Ichikawa
country: Japan
facility: Kohnodai Hospital, National Center for Global Health and Medicine
state: Chiba
city: Matsuyama
country: Japan
facility: Saiseikai Matsuyama Hospital
state: Ehime
city: Kamakura-shi
country: Japan
facility: Takai Internal Medicine Clinic
state: Kanagawa
city: Yokohama-city
country: Japan
facility: Motomachi Takatsuka Naika Clinic
state: Kanagawa
city: Yokohama
country: Japan
facility: Saiseikai Yokohamashi Tobu Hospital
state: Kanagawa
city: Suita-shi
country: Japan
facility: Medical Corporation Heishinkai OCROM Clinic
state: Osaka
city: Suita
country: Japan
facility: Osaka Saiseikai Suita hospital
state: Osaka
city: Takatsuki
country: Japan
facility: Takatsuki Red Cross Hospital
state: Osaka
city: Chuo-ku
country: Japan
facility: The Institute for Adult Disease, Asahi Life Foundation
state: Tokyo
city: Chuo-ku
country: Japan
facility: Tokyo-Eki Center-building Clinic
state: Tokyo
city: Chuo-ku
country: Japan
facility: Medical Corporation Chiseikai Tokyo Center Clinic
state: Tokyo
city: Chuo-ku
country: Japan
facility: Fukuwa Clinic
state: Tokyo
city: Minato-Ku
country: Japan
facility: Saiseikai Central Hospital
state: Tokyo
city: Setagaya-ku
country: Japan
facility: Shimokitazawa Tomo Clinic
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Miho Clinic
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Medical Corporation Heishinkai ToCROM Clinic
state: Tokyo
city: Yamagata-shi
country: Japan
facility: Yamagata Tokushukai Hospital
state: Yamagata
city: Osaka
country: Japan
facility: AMC Nishiumeda Clinic
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: