A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Not Controlled With Diet and Exercise Alone
SURPASS-1
A Randomized, Double-blind, Placebo-Controlled Trial Comparing the Efficacy and Safety of Three Tirzepatide Doses Versus Placebo in Patients With Type 2 Diabetes, Inadequately Controlled With Diet and Exercise Alone
2 other identifiers
interventional
478
5 countries
53
Brief Summary
The goal for this study is to evaluate the efficacy and safety of tirzepatide versus placebo in participants with type 2 diabetes not under control with diet and exercise alone. The study will last approximately 47 weeks and may include about 15 visits.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 type-2-diabetes-mellitus
Started Jun 2019
53 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 15, 2019
CompletedFirst Posted
Study publicly available on registry
May 17, 2019
CompletedStudy Start
First participant enrolled
June 3, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 5, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 28, 2020
CompletedResults Posted
Study results publicly available
October 20, 2021
CompletedOctober 20, 2021
October 1, 2021
1.3 years
May 15, 2019
September 15, 2021
October 18, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Hemoglobin A1c (HbA1c)
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Pooled Country + Prior Use of oral antihyperglycemic medication (OAM) (Yes, No) + Treatment + Time + Treatment\*Time (Type III sum of squares).
Baseline, Week 40
Secondary Outcomes (8)
Change From Baseline in Body Weight
Baseline, Week 40
Percentage of Participants With HbA1c Target Value of <7%
Week 40
Change From Baseline in Fasting Serum Glucose
Baseline, Week 40
Percentage of Participants With HbA1c Target Value of <5.7%
Week 40
Mean Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG) Values
Baseline, Week 40
- +3 more secondary outcomes
Study Arms (4)
5 mg Tirzepatide
EXPERIMENTALParticipants received 5 milligrams (mg) of tirzepatide as subcutaneous injection once a week.
10 mg Tirzepatide
EXPERIMENTALParticipants received 10mg of tirzepatide as subcutaneous injection once a week.
15 mg Tirzepatide
EXPERIMENTALParticipants received 15mg of tirzepatide as subcutaneous injection once a week.
Placebo
PLACEBO COMPARATORParticipants received placebo as subcutaneous injection once a week.
Interventions
Administered SC
Eligibility Criteria
You may qualify if:
- Have been diagnosed with type 2 diabetes mellitus (T2DM).
- 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.
You may not qualify if:
- Have type 1 diabetes mellitus.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (53)
National Research Institute
Huntington Park, California, 90255, United States
National Research Institute
Los Angeles, California, 90057, United States
Catalina Research Institute, LLC
Montclair, California, 91763, United States
Valley Clinical Trials, Inc.
Northridge, California, 91325, United States
National Research Institute
Panorama City, California, 91402, United States
Southern California Dermatology
Santa Ana, California, 92701, United States
Clinical Research of South Florida
Coral Gables, Florida, 33134, United States
Encore Medical Research, LLC
Hollywood, Florida, 33021, United States
Axcess Medical Research
Loxahatchee Groves, Florida, 33470, United States
South Florida Wellness & Clinical Research Institute
Margate, Florida, 33063, United States
Suncoast Research Group, LLC
Miami, Florida, 33135, United States
Agile Clinical Research Trials
Atlanta, Georgia, 30328, United States
Sky Clinical Research Network
Atlanta, Georgia, 30331, United States
Cotton O'Neil Clinic
Topeka, Kansas, 66606, United States
Clinical Research Professionals
Chesterfield, Missouri, 63005, United States
StudyMetrix Research, LLC
City of Saint Peters, Missouri, 63303, United States
Aventiv Research
Columbus, Ohio, 43213, United States
Intend Research
Norman, Oklahoma, 73069, United States
The Corvallis Clinic P.C.
Corvallis, Oregon, 97330, United States
Heritage Valley Medical Group, Inc.
Beaver, Pennsylvania, 15009, United States
Family Medical Associates
Levittown, Pennsylvania, 19056, United States
Preferred Primary Care Physicians
Pittsburgh, Pennsylvania, 15236, United States
Preferred Primary Care Physicians
Uniontown, Pennsylvania, 15401, United States
Dallas Diabetes Endocrine Center
Dallas, Texas, 75230, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229, United States
Consano Clinical Research
Shavano Park, Texas, 78231, United States
Capital Clinical Research Center
Olympia, Washington, 98502, United States
Rockwood Clinic Research Center
Spokane, Washington, 99220, United States
Dr. Jivraj Mehta Smarak Health Foundation
Ahmedabad, Gujarat, 380007, India
Bangalore Medical College and Research Institute
Bangalore, Karnataka, 560 002, India
M S Ramaiah Medical College Hospital
Bangalore, Karnataka, 560054, India
BSES Municipal General Hsptl
Mumbai, Maharashtra, 400058, India
Ruby Hall Clinic and Grant Medical Foundation
Pune, Maharashtra, 411001, India
Vijay Vallabh Hospital
Virār, Maharashtra, 401303, India
Lifepoint Multispecialty Hsptl
Wakad, Pune, 411057, India
Ramdevrao Hospital
Hyderabad, Telangana, 500072, India
Gandhi Hospital
Telangana, 500003, India
Minamiakatsuka Clinic
Mito, Ibaraki, 311-4153, Japan
Takai Naika Clinic
Kamakura, Kanagawa, 247-0056, Japan
Tsuruma Kaneshiro Diabetes Clinic
Yamato, Kanagawa, 242-0004, Japan
Yokohama Minoru Clinic
Yokohama, Kanagawa, 232-0064, Japan
Takatsuki Red Cross Hospital
Takatsuki, Osaka, 569-1096, Japan
Meiwa Hospital
Chiyodaku, Tokyo, 101 0041, Japan
Tokyo-Eki Center-building Clinic
Chuo-ku, Tokyo, 103-0027, Japan
Tokyo Center Clinic
Chuo-ku, Tokyo, 103-0028, Japan
IHL Shinagawa East One Medical Clinic
Minato-ku, Tokyo, 108 0075, Japan
Sato Naika Clinic
Ōta-ku, Tokyo, 143-0015, Japan
Hospital Universitario UANL
Monterrey, Nuevo León, 64460, Mexico
Unidad Medica para la Salud Integral (UMSI)
Monterrey, Nuevo León, 66465, Mexico
Centro de Estudios de Investigacion Metabolicos y Cardiovasc
Madero, Tamaulipas, 89440, Mexico
Investigacion en Salud y Metabolismo S.C
Chihuahua City, 31217, Mexico
GCM Medical Group PSC
San Juan, PR, 00917, Puerto Rico
Clinical Research Puerto Rico, Inc.
San Juan, 00909, Puerto Rico
Related Publications (5)
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.
PMID: 39531161DERIVEDBoye 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.
PMID: 37668888DERIVEDBoye 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.
PMID: 37526908DERIVEDSattar 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.
PMID: 35210595DERIVEDRosenstock 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.
PMID: 34186022DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- STUDY DIRECTOR
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)
Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 15, 2019
First Posted
May 17, 2019
Study Start
June 3, 2019
Primary Completion
October 5, 2020
Study Completion
October 28, 2020
Last Updated
October 20, 2021
Results First Posted
October 20, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.