A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Who Have Obesity or Are Overweight
- Conditions
- OverweightType 2 DiabetesObesity
- Interventions
- Other: PlaceboDrug: Tirzepatide
- Registration Number
- NCT04657003
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
This is a study of tirzepatide in participants with type 2 diabetes who have obesity or are overweight. The main purpose is to learn more about how tirzepatide affects body weight. The study will last 79 weeks (22 visits).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 938
- Have Type 2 Diabetes (T2DM) with HbA1c ≥7% to ≤10% at screening, on stable therapy for the last 3 months prior to screening. T2DM may be treated with diet/exercise alone or any oral glycemic-lowering agent (as per local labeling) EXCEPT dipeptidyl peptidase 4 (DPP-4) inhibitors or glucagon like peptide-1 receptor agonists (GLP-1 RAs)
- Have a BMI of ≥27 kg/m²
- Are overweight or have obesity
- Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight
- Are at least 18 years of age and age of majority per local laws and regulations
- Have Type 1 diabetes mellitus, history of ketoacidosis or hyperosmolar state/coma or any other types of diabetes except T2DM
- Have at least 2 confirmed fasting self-monitoring blood glucose (SMBG) values >270 mg/dL(on 2 nonconsecutive days) prior to Visit 3
- Have proliferative diabetic retinopathy OR diabetic macular edema OR non-proliferative diabetic retinopathy that requires acute treatment
- Have self-reported change in body weight >5kg within 3 months prior to screening
- Have had a history of chronic or acute pancreatitis
- 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
- 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 QW 10 milligrams (mg) Tirzepatide Tirzepatide 10 mg Tirzepatide administered subcutaneously (SC) once weekly (QW) 15 mg Tirzepatide Tirzepatide 15 mg Tirzepatide administered SC QW
- Primary Outcome Measures
Name Time Method Percent Change From Baseline in Body Weight Baseline, Week 72 Least Squares Mean (LSMean) calculated using Mixed Model Repeated Measures (MMRM) model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Type of Antihyperglycemic Medication (AHM) Used at Randomization + Treatment + Time + Treatment\*Time (Type III sum of squares).
Percentage of Participants Who Achieve ≥5% Body Weight Reduction From Baseline Week 72 Percentage of participants who achieve ≥5% body weight reduction from baseline
- Secondary Outcome Measures
Name Time Method Percentage of Participants Who Achieve ≥15% Body Weight Reduction From Baseline Week 72 Percentage of participants who achieve ≥15% body weight reduction from baseline
Change From Baseline in Fasting Glucose Baseline, Week 72 LSMean calculated using MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Type of AHM Used at Randomization + Baseline HbA1c Group (\<=8.5%, \>8.5%) + Treatment + Time + Treatment\*Time (Type III sum of squares).
Change From Baseline in Waist Circumference Baseline, Week 72 LSMean calculated using MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Type of AHM Used at Randomization + Treatment + Time + Treatment\*Time (Type III sum of squares).
Percent Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg) Baseline, Week 72 Results are reported as model-based estimates and SE from MMRM analysis using log transformation.
Percent Change From Baseline in Non-High Density Lipoprotein (Non-HDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg) Baseline, Week 72 Results are reported as model-based estimates and SE from MMRM analysis using log transformation.
Percent Change From Baseline in Triglycerides (Pooled Doses of Tirzepatide 10 mg and 15 mg) Baseline, Week 72 Results are reported as model-based estimates and SE from MMRM analysis using log transformation.
Percent Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg) Baseline, Week 72 Results are reported as model-based estimates and SE from MMRM analysis using log transformation.
Percentage of Participants Who Achieve ≥10% Body Weight Reduction From Baseline Week 72 Percentage of participants who achieve ≥10% body weight reduction from baseline
Change From Baseline in Absolute Body Weight Baseline, Week 72 LSMean calculated using MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Type of AHM Used at Randomization + Treatment + Time + Treatment\*Time (Type III sum of squares).
Percentage of Participants Who Achieve HbA1c ≤6.5% Week 72 Percentage of participants who achieve HbA1c ≤6.5%
Change From Baseline in Diastolic Blood Pressure (DBP) (Pooled Doses of 10 mg and 15 mg Tirzepatide) Baseline, Week 72 LSMean was calculated using MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Type of AHM Used at Randomization + Treatment + Time + Treatment\*Time (Type III sum of squares).
Change From Baseline in Short Form 36 Health Survey Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score 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 Body Mass Index (BMI) Baseline, Week 72 LSMean calculated using MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Type of AHM Used at Randomization + Treatment + Time + Treatment\*Time (Type III sum of squares).
Percentage of Participants Who Achieve ≥20% Body Weight Reduction From Baseline Week 72 Percentage of participants who achieve ≥20% body weight reduction from baseline
Change From Baseline in Hemoglobin A1c (HbA1c) Baseline, Week 72 LSMean calculated using MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Type of AHM Used at Randomization + Treatment + Time + Treatment\*Time (Type III sum of squares).
Percentage of Participants Who Achieve HbA1c <7% Week 72 Percentage of participants who achieve HbA1c \<7%
Percentage of Participants Who Achieve HbA1c <5.7% Week 72 Percentage of participants who achieve HbA1c \<5.7%
Percent Change From Baseline in Total Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg) Baseline, Week 72 Results are reported as model-based estimates and standard error (SE) from MMRM analysis using log transformation.
Percent Change From Baseline in High Density Lipoprotein (HDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg) Baseline, Week 72 Results are reported as model-based estimates and SE from MMRM analysis using log transformation.
Percent Change From Baseline in Free Fatty Acids (Pooled Doses of 10 mg and 15 mg Tirzepatide) Baseline, Week 72 Results are reported as model-based estimates and SE from MMRM analysis using log transformation.
Change From Baseline in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL Lite-CT) Physical Function Composite Score Baseline, Week 72 The IWQOL-Lite-CT is a 20-item, obesity-specific patient reported outcome (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.
Change From Baseline in Systolic Blood Pressure (SBP) (Pooled Doses of 10 mg and 15 mg Tirzepatide) Baseline, Week 72 LSMean was calculated using MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Type of AHM Used at Randomization + Treatment + Time + Treatment\*Time (Type III sum of squares).
Percent Change From Baseline in Fasting Insulin Baseline, Week 72 Results are reported as model-based estimates and SE from MMRM analysis using log transformation.
Population Pharmacokinetics (PopPK): Steady State Area Under the Concentration Curve (AUC) of Tirzepatide Week 8, 16, 36: 1 to 24 hours, 24 to 96 hours, or 120 to 168 hours postdose Each participant was 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. The steady state AUC was evaluated using Population PK modeling.
Trial Locations
- Locations (75)
Emory University School of Medicine- Grady Campus
🇺🇸Atlanta, Georgia, United States
PharmQuest
🇺🇸Greensboro, North Carolina, United States
East Coast Institute for Research, LLC
🇺🇸Macon, Georgia, United States
Dallas Diabetes Research Center
🇺🇸Dallas, Texas, United States
Rocky Mountain Clinical Research
🇺🇸Idaho Falls, Idaho, United States
NECCR PrimaCare Research
🇺🇸Fall River, Massachusetts, United States
Aventiv Research
🇺🇸Dublin, Ohio, United States
American Health Network of Indiana, LLC - Greenfield
🇺🇸Greenfield, Indiana, United States
Russian Medical Academy of Postgraduate Education
🇷🇺Moscow, Moskva, Russian Federation
Juno Research
🇺🇸Houston, Texas, United States
Endocrine Ips, Pllc
🇺🇸Houston, Texas, United States
AMC Nishiumeda Clinic
🇯🇵Osaka, Japan
Cotton O'Neil Clinical Research Center
🇺🇸Topeka, Kansas, United States
University of Alabama - Department of Nutrition Sciences
🇺🇸Birmingham, Alabama, United States
New Horizon Research Center
🇺🇸Miami, Florida, United States
Tribe Clinical Research, LLC
🇺🇸Greenville, South Carolina, United States
Instituto de Pesquisa clinica de Campinas
🇧🇷Campinas, São Paulo, Brazil
ILS Hospitals
🇮🇳Kolkata, West Bengal, India
CIPREC
🇦🇷Caba, Ciudad Autónoma De Buenos Aire, Argentina
Logan Health Research
🇺🇸Kalispell, Montana, United States
Centro de Investigaciones Médicas Tucuman
🇦🇷SAN M. DE Tucuman, Tucumán, Argentina
Loema Instituto de Pesquisa Clinica
🇧🇷Campinas, São Paulo, Brazil
Private Practice - Dr.Miguel N. Hissa
🇧🇷Fortaleza, Ceará, Brazil
Elite Clinical Trials
🇺🇸Blackfoot, Idaho, United States
CPCLIN
🇧🇷Sao Paulo, São Paulo, Brazil
Go Centro Medico San Nicolás
🇦🇷San Nicolas, Buenos Aires, Argentina
Centro Médico Viamonte
🇦🇷Buenos Aires, Ciudad Autónoma De Buenos Aire, Argentina
Life Care Hospital and Research Centre
🇮🇳Bangalore, Karnataka, India
National Cheng-Kung Uni. Hosp.
🇨🇳Tainan, Taiwan
Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic
🇯🇵Yamato-shi, Kanagawa, Japan
GCM Medical Group, PSC - Hato Rey Site
🇵🇷San Juan, Puerto Rico
Endocrinology Research Center of Rosmedtechnologies
🇷🇺Moscow, Moskva, Russian Federation
Premier Research
🇺🇸Trenton, New Jersey, United States
Sanatorio Norte
🇦🇷Santiago del Estero, Argentina
Medical Corporation Sato Medical clinic
🇯🇵Ootaku, Tokyo, Japan
CECIP - Centro de Estudos do Interior Paulista
🇧🇷Jaú, São Paulo, Brazil
Latin Clinical Trial Center
🇵🇷San Juan, Puerto Rico
Saint-Petersburg City Hospital of Saint Elizabeth
🇷🇺Saint Petersburg, Sankt-Pete, Russian Federation
Changhua Christian Hospital
🇨🇳Changhua County, Changhua, Taiwan
Chi Mei Medical Center
🇨🇳Tainan City, Tainan, Taiwan
Taichung Veterans General Hospital
🇨🇳Taichung, Taiwan
Smolensk State Medical University
🇷🇺Smolensk, Russian Federation
Chung Shan Medical University Hospital
🇨🇳Taichung, Taiwan
Center for Neurosciences
🇺🇸Warwick, Rhode Island, United States
KLR Business Group, Inc. dba Arkansas Clinical Research
🇺🇸Little Rock, Arkansas, United States
Velocity Clinical Research, Huntington Park
🇺🇸Huntington Park, California, United States
Catalina Research Institute, LLC
🇺🇸Montclair, California, United States
University Clinical Investigators, Inc.
🇺🇸Tustin, California, United States
Velocity Clinical Research, Westlake
🇺🇸Los Angeles, California, United States
Encompass Clinical Research
🇺🇸Spring Valley, California, United States
ALL Medical Research, LLC
🇺🇸Cooper City, Florida, United States
Northeast Research Institute (NERI)
🇺🇸Fleming Island, Florida, United States
West Orange Endocrinology
🇺🇸Ocoee, Florida, United States
Metabolic Research Institute, Inc.
🇺🇸West Palm Beach, Florida, United States
Iowa Diabetes and Endocrinology Research Center
🇺🇸West Des Moines, Iowa, United States
Maryland Cardiovascular Specialists
🇺🇸Baltimore, Maryland, United States
MD Medical Research
🇺🇸Oxon Hill, Maryland, United States
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
🇺🇸Troy, Michigan, United States
Preferred Primary Care Physicians
🇺🇸Uniontown, Pennsylvania, United States
The Corvallis Clinic, P.C.
🇺🇸Corvallis, Oregon, United States
Velocity Clinical Research, Cleveland
🇺🇸Cleveland, Ohio, United States
Health Research of Hampton Roads, Inc.
🇺🇸Newport News, Virginia, United States
Rainier Clinical Research Center
🇺🇸Renton, Washington, United States
Consultorio de Investigación Clínica EMO SRL
🇦🇷Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina
Clinical Investigation Specialists
🇺🇸Kenosha, Wisconsin, United States
Centro de Investigaciones Metabólicas (CINME)
🇦🇷Ciudad Autónoma de Buenos Aire, Buenos Aires, Argentina
Instituto de Investigaciones Clínicas Mar del Plata
🇦🇷Mar del Plata, Buenos Aires, Argentina
CEPIC - Centro Paulista de Investigação Clínica
🇧🇷São Paulo, Brazil
Medical Corporation Heishinkai OCROM Clinic
🇯🇵Suita-shi, Osaka, Japan
Centro de Endocrinologia y Nutricion
🇵🇷Caguas, Puerto Rico
Diabetes and Thyroid Center of Fort Worth
🇺🇸Fort Worth, Texas, United States
Pacific Diabetes & Endocrine Center
🇺🇸Honolulu, Hawaii, United States
Wake Forest University Baptist Medical Center (WFUBMC)
🇺🇸Winston-Salem, North Carolina, United States
Texas Diabetes & Endocrinology, P.A.
🇺🇸Austin, Texas, United States
University of North Carolina Medical Center
🇺🇸Chapel Hill, North Carolina, United States
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