A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight
- Registration Number
- NCT04184622
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
This is a study of tirzepatide in participants with overweight and obesity. The main purpose is to learn more about how tirzepatide affects body weight. The study has two phases: A main phase and an extension phase. The main phase of the study will last 72 weeks. Participants with prediabetes will continue in the extension for another 2 years.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2539
- Body mass Index (BMI) ≥30 kilograms per square meter (kg/m²), or ≥27 kg/m² and previous diagnosis with at least one of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease
- History of at least one unsuccessful dietary effort to lose body weight
- Diabetes mellitus
- Change in body weight greater than 5 kg within 3 months prior to starting study
- Obesity induced by other endocrinologic disorders or monogenetic or syndromic forms of obesity
- History of pancreatitis
- Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
- History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder within the last 2 years
- Any lifetime history of a suicide attempt
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo administered SC once a week. 10 mg Tirzepatide Tirzepatide 10 mg tirzepatide administered SC once a week. 15 mg Tirzepatide Tirzepatide 15 mg tirzepatide administered SC once a week. 5 mg Tirzepatide Tirzepatide 5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.
- Primary Outcome Measures
Name Time Method Percent Change From Baseline in Body Weight Baseline, Week 72 Least Squares (LS) Mean was calculated using mixed-model repeated measures (MMRM) with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment\*time (Type III sum of squares) in the model.
Percentage of Participants Who Achieve ≥5% Body Weight Reduction Week 72 Percentage of participants who achieve ≥5% body weight reduction.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Who Achieve ≥20% Body Weight Reduction Week 72 Percentage of participants who achieve ≥20% body weight reduction.
Percent Change From Baseline in Fasting Insulin (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) Baseline, Week 72 Fasting Insulin is a test used to measure the amount of insulin in the body. Results are reported as model-based estimates and SE from MMRM analysis using log transformation.
Change From Baseline in Hemoglobin A1c (HbA1c) Baseline, Week 72 HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. LS Mean was calculated using MMRM with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment\*time (Type III sum of squares) in the model.
Percent Change From Baseline in Low-Density Lipoprotein (LDL) Cholesterol (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) Baseline, Week 72 Results are reported as model-based estimate and SE from MMRM analysis using log transformation.
Percent Change From Baseline in Very Low-Density Lipoprotein (VLDL) Cholesterol (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) Baseline, Week 72 Results are reported as model-based estimate and SE from MMRM analysis using log transformation.
Percent Change From Baseline in Free Fatty Acids (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) Baseline, Week 72 Results are reported as model-based estimate and SE from MMRM analysis using log transformation.
Change From Baseline in Body Weight (Pooled Doses of Tirzepatide 10 mg and 15 mg) Baseline, Week 20 LS Mean was calculated using MMRM with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment\*time (Type III sum of squares) in the model.
Percentage of Participants Who Achieve ≥5% Body Weight Reduction Week 176 Percentage of Participants who Achieve ≥5% Body Weight Reduction.
Change From Baseline in Fasting Glucose Baseline, Week 72 LS Mean was calculated using MMRM with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment\*time (Type III sum of squares) in the model.
Percent Change From Baseline in Triglycerides (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) Baseline, Week 72 Percent change from baseline in triglycerides are reported as model-based estimate and Standard Error (SE) from MMRM analysis using log transformation.
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 Waist Circumference Baseline, Week 72 LS Mean was calculated using MMRM with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment\*time (Type III sum of squares) in the model.
Change From Baseline in Body Mass Index (BMI) Baseline, Week 72 LS Mean was calculated using MMRM with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment\*time (Type III sum of squares) in the model.
Percent Change From Baseline in Body Weight Baseline, Week 176 Percent Change from Baseline in Body Weight.
Time to Onset of Type 2 Diabetes Baseline through Week 176 Time to Onset of Type 2 Diabetes
Percent Change From Baseline in Total Cholesterol (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) Baseline, Week 72 Results are reported as model-based estimate and SE from MMRM analysis using log transformation.
Percent Change From Baseline in High-Density Lipoprotein (HDL) Cholesterol at Week 72 (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) Baseline, Week 72 Results are reported as model-based estimate and SE from MMRM analysis using log transformation.
Change From Baseline in Systolic Blood Pressure (SBP) (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) Baseline, Week 72 LS Mean was calculated using MMRM with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment\*time (Type III sum of squares) in the model.
Change From Baseline in Diastolic Blood Pressure (DBP) (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) Baseline, Week 72 LS Mean was calculated using MMRM with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment\*time (Type III sum of squares) in the model.
Change From Baseline in Short Form Survey-36 Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score at Week 72 (Pooled Doses of Tirzepatide 10 mg and 15 mg) Baseline, Week 72 The SF-36v2 acute, 1-week recall version is a 36-item, generic, patient-administered measure designed to assess the following 8 domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. The Physical-Functioning domain assesses limitations due to health "now" while the remaining domains assess functioning "in the past week." Each domain is scored individually and information from these 8 domains are further aggregated into 2 health-component summary scores: Physical-Component Summary and Mental-Component Summary. Items are answered on Likert scales of varying lengths (3-, 5-, or 6- point scales).The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health.
Change From Baseline in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score at Week 72 Baseline, Week 72 The IWQOL-Lite-CT is a 20-item, obesity-specific PRO instrument developed for use in obesity clinical trials. It assesses 2 primary domains of obesity-related health-related quality of life (HRQoL): physical (7 items), and psychosocial (13 items). A 5-item subset of the physical domain, the physical-function composite is also supported. Items in the physical-function composite describe physical impacts related to general and specific physical activities. All items in the physical domain are rated on either a 5-point frequency ("never" to "always") scale or a 5-point truth ("not at all true" to "completely true") scale. Total score of IWQOL-Lite-CT composite ranges from 0 to 100, with higher scores reflecting better quality of life.
Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) of Tirzepatide Week 8, 16, and 36, at 1 to 24 hours, 24 to 96 hours, or 120 to 168 hours postdose PK: Steady State AUC of Tirzepatide. each participant will be assigned via the Interactive Web Response System (IWRS) to one of the sampling PK time windows of 1 to 24 hours, 24 to 96 hours, or 120 to 168 hours postdose.
Trial Locations
- Locations (117)
National Research Institute - Wilshire
🇺🇸Los Angeles, California, United States
University Clinical Investigators, Inc.
🇺🇸Tustin, California, United States
Clinvest Research LLC
🇺🇸Springfield, Missouri, United States
PharmQuest
🇺🇸Greensboro, North Carolina, United States
Aventiv Research Inc
🇺🇸Columbus, Ohio, United States
WR-Clinsearch, LLC
🇺🇸Chattanooga, Tennessee, United States
Dallas Diabetes Research Center
🇺🇸Dallas, Texas, United States
North Texas Endocrine Center
🇺🇸Dallas, Texas, United States
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
🇲🇽Monterrey, Nuevo León, Mexico
Velocity Clinical Research, Cleveland
🇺🇸Cleveland, Ohio, United States
Premier Research
🇺🇸Trenton, New Jersey, United States
Oviedo Medical Research
🇺🇸Oviedo, Florida, United States
Instituto de Pesquisa clinica de Campinas
🇧🇷Campinas, São Paulo, Brazil
GO Centro Médico San Nicolás
🇦🇷San Nicolás, Buenos Aires, Argentina
Instituto Brasil de Pesquisa Clínica - IBPCLIN
🇧🇷Rio de Janeiro, Brazil
CPQuali Pesquisa Clínica
🇧🇷São Paulo, Brazil
Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares
🇲🇽Mexico City, Distrito Federal, Mexico
New Horizon Research Center
🇺🇸Miami, Florida, United States
Midwest Institute for Clinical Research
🇺🇸Indianapolis, Indiana, United States
Palm Research Center Sunset
🇺🇸Las Vegas, Nevada, United States
Lillestol Research
🇺🇸Fargo, North Dakota, United States
CPCLIN
🇧🇷São Paulo, Brazil
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
Cotton O'Neil Diabetes & Endocrinology
🇺🇸Topeka, Kansas, United States
John Muir Physician Network Clinical Research Center
🇺🇸Concord, California, United States
The Fourth Affiliated Hospital of Harbin Medical University
🇨🇳Harbin, Heilongjiang, China
Gujarat Endocrine Center
🇮🇳Ahmedabad, Gujarat, India
Summit Research Network
🇺🇸Portland, Oregon, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
CEDOES
🇧🇷Vitoria, Espírito Santo, Brazil
Deenanath Mangeshkar Hospital & Research Centre
🇮🇳Pune, Maharashtra, India
Virgen Cardiovascular Research S.C
🇲🇽Guadalajara, Jalisco, Mexico
Medical Corporation Chiseikai Tokyo Center Clinic
🇯🇵Chuo-ku, Tokyo, Japan
Manati Center for Clinical Research
🇵🇷Manati, Puerto Rico
Centro Para El Desarrollo de La Medicina Y de Asistencia Medica Especializada S.C.
🇲🇽Culiacan Rosales, Sinaloa, Mexico
Sir J.J. Group of Hospitals
🇮🇳Mumbai, Maharashtra, India
Fukuwa Clinic
🇯🇵Chuo-ku, Tokyo, Japan
Ningbo First Hospital
🇨🇳Ningbo, Zhejiang, China
The Second Affiliated Hospital of Nanjing Medical University
🇨🇳Nanjing, Jiangsu, China
Jinan Central Hospital
🇨🇳Jinan, Shandong, China
Private Practice - Dr. Luis Rivera Colon
🇵🇷San Juan, Puerto Rico
State Research Center for Preventive Medicine
🇷🇺Moscow, Moskva, Russian Federation
Izhevsk City Clinical Hospital Number 9
🇷🇺Izhevsk, Udmurtskaya Respublika, Russian Federation
National Cheng Kung University Hospital
🇨🇳Tainan, Taiwan
Russian Cardiology Research and Production Complex
🇷🇺Moscow, Moskva, Russian Federation
StudyMetrix Research
🇺🇸Saint Peters, Missouri, United States
NYU Langone Health
🇺🇸New York, New York, United States
Center for Advanced Research & Education
🇺🇸Gainesville, Georgia, United States
Weill Cornell Medical College
🇺🇸New York, New York, United States
Alliance for Multispecialty Research, LLC
🇺🇸Norman, Oklahoma, United States
Consano Clinical Research, LLC
🇺🇸Shavano Park, Texas, United States
Herman Clinical Research
🇺🇸Suwanee, Georgia, United States
CEPIC - Centro Paulista de Investigação Clínica
🇧🇷São Paulo, Brazil
Perseverance Research Center
🇺🇸Scottsdale, Arizona, United States
Cahaba Research
🇺🇸Pelham, Alabama, United States
Valley Research
🇺🇸Fresno, California, United States
Catalina Research Institute, LLC
🇺🇸Montclair, California, United States
Encompass Clinical Research
🇺🇸Spring Valley, California, United States
Renstar Medical Research
🇺🇸Ocala, Florida, United States
East-West Medical Research Institute
🇺🇸Honolulu, Hawaii, United States
L-MARC Research Center
🇺🇸Louisville, Kentucky, United States
SKY Integrative Medical Center/SKYCRNG
🇺🇸Union City, Georgia, United States
Iowa Diabetes and Endocrinology Research Center
🇺🇸West Des Moines, Iowa, United States
ActivMed Practices and Research
🇺🇸Methuen, Massachusetts, United States
NECCR PrimaCare Research
🇺🇸Fall River, Massachusetts, United States
University of North Carolina Medical Center
🇺🇸Chapel Hill, North Carolina, United States
Rochester Clinical Research, LLC
🇺🇸Rochester, New York, United States
Detweiler Family Medicine & Associates
🇺🇸Lansdale, Pennsylvania, United States
Preferred Primary Care Physicians
🇺🇸Uniontown, Pennsylvania, United States
Velocity Clinical Research, Providence
🇺🇸East Greenwich, Rhode Island, United States
Centro de Investigaciones Metabólicas (CINME)
🇦🇷Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Texas Diabetes & Endocrinology, P.A.
🇺🇸Round Rock, Texas, United States
Research Institute of Dallas
🇺🇸Dallas, Texas, United States
Southern Endocrinology Associates
🇺🇸Mesquite, Texas, United States
Coastal Carolina Research Center
🇺🇸North Charleston, South Carolina, United States
Stat Research S.A.
🇦🇷Caba, Buenos Aires, Argentina
The First Affiliated Hospital of Xi'an Medical University
🇨🇳Xi'an, Shanxi, China
Beijing Tsinghua Changgung Hospital
🇨🇳Changping, Beijing, China
West China Hospital, Sichuan University
🇨🇳Chengdu, Sichuan, China
Fortis Hospital
🇮🇳Delhi, India
ILS Hospital
🇮🇳Kolkata, West Bengal, India
Tokyo-Eki Center-building Clinic
🇯🇵Chuo-ku, Tokyo, Japan
Centro de Investigacion en Artritis y Osteoporosis SC
🇲🇽Mexicali, Baja California, Mexico
AMC Nishiumeda Clinic
🇯🇵Osaka, Japan
Investigacion en Salud y Metabolismo S.C
🇲🇽Chihuahua, Mexico
Ponce Medical School Foundation Inc.
🇵🇷Ponce, Puerto Rico
Latin Clinical Trial Center
🇵🇷San Juan, Puerto Rico
Arké SMO S.A de C.V
🇲🇽Veracruz, Mexico
Ivanovo Regional Healthcare Institution Cardiology Dispensary
🇷🇺Ivanovo, Ivanovskaya Oblast', Russian Federation
Endocrinology Research Center of Rosmedtechnologies
🇷🇺Moscow, Moskva, Russian Federation
Immanuel Kant Baltic Federal University
🇷🇺Kaliningrad, Kaliningradskaya Oblast', Russian Federation
Pirogov Russian National Research Medical University
🇷🇺Moscow, Moskva, Russian Federation
St Petersburg SBHI City Hospital No. 38 Named After Semashko
🇷🇺St. Petersburg, Sankt-Peterburg, Russian Federation
Research Institute of Therapy and Preventive Medicine
🇷🇺Novosibirsk, Novosibirskaya Oblast', Russian Federation
Instituto de Investigaciones Clínicas Mar del Plata
🇦🇷Mar del Plata, Buenos Aires, Argentina
Mountain View Clinical Research, Inc.
🇺🇸Greer, South Carolina, United States
DIM Clinica Privada
🇦🇷Ramos Mejía, Buenos Aires, Argentina
Hospital da Clinicas da Faculdade de Medicina da USP
🇧🇷São Paulo, Brazil
Suncoast Research Group
🇺🇸Miami, Florida, United States
Unidad de Investigacion Clinica y Atencion Medica HEPA
🇲🇽Guadalajara, Jalisco, Mexico
ForCare Clinical Research
🇺🇸Tampa, Florida, United States
Centro Médico Viamonte
🇦🇷Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
CEDIC
🇦🇷Caba, Buenos Aires, Argentina
Consultorio de Investigación Clínica EMO SRL
🇦🇷Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Medical Corporation Heishinkai OCROM Clinic
🇯🇵Suita-shi, Osaka, Japan
RM Pharma Specialists
🇲🇽Mexico City, Distrito Federal, Mexico
Chi-Mei Medical Center
🇨🇳Tainan City, Tainan, Taiwan
Chung Shan Medical University Hospital
🇨🇳Taichung, Taiwan
China Medical University Hospital
🇨🇳Taichung, Taiwan
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
🇺🇸Troy, Michigan, United States
Chase Medical Research, LLC
🇺🇸Waterbury, Connecticut, United States
Mautalen Salud e Investigación
🇦🇷Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
National Taiwan University Hospital
🇨🇳Taipei City, Taipei, Taiwan
GCM Medical Group, PSC- Hato Rey Site
🇵🇷San Juan, Puerto Rico
Care Hospitals Hyderabad- Banjara Hills
🇮🇳Hyderabad, Telangana, India
Loema - Instituto de Pesquisa Clinica
🇧🇷Campinas, São Paulo, Brazil
Instituto de Diabetes, Obesidad y Nutricion
🇲🇽Cuernavaca, Morelos, Mexico
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