A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Not Controlled With Diet and Exercise Alone
NCT ID: NCT03954834
Last Updated: 2021-10-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
478 participants
INTERVENTIONAL
2019-06-03
2020-10-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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5 mg Tirzepatide
Participants received 5 milligrams (mg) of tirzepatide as subcutaneous injection once a week.
Tirzepatide
Administered SC
10 mg Tirzepatide
Participants received 10mg of tirzepatide as subcutaneous injection once a week.
Tirzepatide
Administered SC
15 mg Tirzepatide
Participants received 15mg of tirzepatide as subcutaneous injection once a week.
Tirzepatide
Administered SC
Placebo
Participants received placebo as subcutaneous injection once a week.
Placebo
Administered SC
Interventions
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Tirzepatide
Administered SC
Placebo
Administered SC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Are naïve to diabetes injectable therapies and have not used any oral antihyperglycemic medications (OAMs) during the 3 months preceding screening.
* Have HbA1c between ≥7.0% and ≤9.5%.
* Be of stable weight (± 5%) for at least 3 months before screening.
* Have a BMI ≥23 kilograms per meter squared (kg/m²) at screening.
Exclusion Criteria
* Have had chronic or acute pancreatitis any time prior to study entry.
* Have proliferative diabetic retinopathy or diabetic maculopathy or nonproliferative diabetic retinopathy requiring acute treatment.
* Have disorders associated with slowed emptying of the stomach, or have had any stomach surgeries for the purpose of weight loss.
* Have an estimated glomerular filtration rate \<30 mL/minute/1.73 m².
* Have had a heart attack, stroke, or hospitalization for congestive heart failure in the past 2 months.
* Have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2.
* Have been taking weight loss drugs, including over-the-counter medications during the last 3 months.
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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
Eli Lilly and Company
Locations
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National Research Institute
Huntington Park, California, United States
National Research Institute
Los Angeles, California, United States
Catalina Research Institute, LLC
Montclair, California, United States
Valley Clinical Trials, Inc.
Northridge, California, United States
National Research Institute
Panorama City, California, United States
Southern California Dermatology
Santa Ana, California, United States
Clinical Research of South Florida
Coral Gables, Florida, United States
Encore Medical Research, LLC
Hollywood, Florida, United States
Axcess Medical Research
Loxahatchee Groves, Florida, United States
South Florida Wellness & Clinical Research Institute
Margate, Florida, United States
Suncoast Research Group, LLC
Miami, Florida, United States
Agile Clinical Research Trials
Atlanta, Georgia, United States
Sky Clinical Research Network
Atlanta, Georgia, United States
Cotton O'Neil Clinic
Topeka, Kansas, United States
Clinical Research Professionals
Chesterfield, Missouri, United States
StudyMetrix Research, LLC
City of Saint Peters, Missouri, United States
Aventiv Research
Columbus, Ohio, United States
Intend Research
Norman, Oklahoma, United States
The Corvallis Clinic P.C.
Corvallis, Oregon, United States
Heritage Valley Medical Group, Inc.
Beaver, Pennsylvania, United States
Family Medical Associates
Levittown, Pennsylvania, United States
Preferred Primary Care Physicians
Pittsburgh, Pennsylvania, United States
Preferred Primary Care Physicians
Uniontown, Pennsylvania, United States
Dallas Diabetes Endocrine Center
Dallas, Texas, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States
Consano Clinical Research
Shavano Park, Texas, United States
Capital Clinical Research Center
Olympia, Washington, United States
Rockwood Clinic Research Center
Spokane, Washington, United States
Dr. Jivraj Mehta Smarak Health Foundation
Ahmedabad, Gujarat, India
Bangalore Medical College and Research Institute
Bangalore, Karnataka, India
M S Ramaiah Medical College Hospital
Bangalore, Karnataka, India
BSES Municipal General Hsptl
Mumbai, Maharashtra, India
Ruby Hall Clinic and Grant Medical Foundation
Pune, Maharashtra, India
Vijay Vallabh Hospital
Virār, Maharashtra, India
Lifepoint Multispecialty Hsptl
Wākad, Pune, India
Ramdevrao Hospital
Hyderabad, Telangana, India
Gandhi Hospital
Telangana, , India
Minamiakatsuka Clinic
Mito, Ibaraki, Japan
Takai Naika Clinic
Kamakura, Kanagawa, Japan
Tsuruma Kaneshiro Diabetes Clinic
Yamato, Kanagawa, Japan
Yokohama Minoru Clinic
Yokohama, Kanagawa, Japan
Takatsuki Red Cross Hospital
Takatsuki, Osaka, Japan
Meiwa Hospital
Chiyodaku, Tokyo, Japan
Tokyo-Eki Center-building Clinic
Chuo-ku, Tokyo, Japan
Tokyo Center Clinic
Chuo-ku, Tokyo, Japan
IHL Shinagawa East One Medical Clinic
Minato-ku, Tokyo, Japan
Sato Naika Clinic
Ōta-ku, Tokyo, Japan
Hospital Universitario UANL
Monterrey, Nuevo León, Mexico
Unidad Medica para la Salud Integral (UMSI)
Monterrey, Nuevo León, Mexico
Centro de Estudios de Investigacion Metabolicos y Cardiovasc
Madero, Tamaulipas, Mexico
Investigacion en Salud y Metabolismo S.C
Chihuahua City, , Mexico
GCM Medical Group PSC
San Juan, PR, Puerto Rico
Clinical Research Puerto Rico, Inc.
San Juan, , Puerto Rico
Countries
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References
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De Block C, Peleshok J, Wilding JPH, Kwan AYM, Rasouli N, Maldonado JM, Wysham C, Liu M, Aleppo G, Benneyworth BD. Post Hoc Analysis of SURPASS-1 to -5: Efficacy and Safety of Tirzepatide in Adults with Type 2 Diabetes are Independent of Baseline Characteristics. Diabetes Ther. 2025 Jan;16(1):43-71. doi: 10.1007/s13300-024-01660-0. Epub 2024 Nov 12.
Boye KS, Sapin H, Dong W, Williamson S, Lee CJ, Thieu VT. Improved Glycaemic and Weight Management Are Associated with Better Quality of Life in People with Type 2 Diabetes Treated with Tirzepatide. Diabetes Ther. 2023 Nov;14(11):1867-1887. doi: 10.1007/s13300-023-01457-7. Epub 2023 Sep 5.
Boye KS, Thieu VT, Sapin H, Lee CJ, Lando LF, Brown K, Bray R, Wiese RJ, Patel H, Rodriguez A, Yu M. Patient-Reported Outcomes in People with Type 2 Diabetes Receiving Tirzepatide in the SURPASS Clinical Trial Programme. Diabetes Ther. 2023 Nov;14(11):1833-1852. doi: 10.1007/s13300-023-01451-z. Epub 2023 Aug 1.
Sattar N, McGuire DK, Pavo I, Weerakkody GJ, Nishiyama H, Wiese RJ, Zoungas S. Tirzepatide cardiovascular event risk assessment: a pre-specified meta-analysis. Nat Med. 2022 Mar;28(3):591-598. doi: 10.1038/s41591-022-01707-4. Epub 2022 Feb 24.
Rosenstock J, Wysham C, Frias JP, Kaneko S, Lee CJ, Fernandez Lando L, Mao H, Cui X, Karanikas CA, Thieu VT. Efficacy and safety of a novel dual GIP and GLP-1 receptor agonist tirzepatide in patients with type 2 diabetes (SURPASS-1): a double-blind, randomised, phase 3 trial. Lancet. 2021 Jul 10;398(10295):143-155. doi: 10.1016/S0140-6736(21)01324-6. Epub 2021 Jun 27.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Not Controlled With Diet and Exercise Alone (SURPASS-1)
Other Identifiers
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I8F-MC-GPGK
Identifier Type: OTHER
Identifier Source: secondary_id
17000
Identifier Type: -
Identifier Source: org_study_id