A Study of Tirzepatide Compared With Intensified Conventional Care in Adult Participants With Type 2 Diabetes
SURPASS-EARLY
A Randomized, Open-Label, Parallel-Group, Two-Arm, Phase 4 Study to Evaluate the Long-Term Efficacy and Safety of Tirzepatide Compared With Intensified Conventional Care in Adults When Initiating Treatment Early in the Course of Type 2 Diabetes
5 other identifiers
interventional
780
11 countries
90
Brief Summary
This study aims to investigate the efficacy and safety of tirzepatide in participants with type 2 diabetes (T2D) compared to other existing treatment options when treatment is initiated early.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 type-2-diabetes
Started Aug 2022
Longer than P75 for phase_4 type-2-diabetes
90 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
June 22, 2022
CompletedFirst Posted
Study publicly available on registry
June 27, 2022
CompletedStudy Start
First participant enrolled
August 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 21, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2027
ExpectedDecember 12, 2025
December 1, 2025
3.2 years
June 22, 2022
December 5, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from Baseline in Hemoglobin A1c (HbA1c)
Baseline, Week 104
Secondary Outcomes (33)
Change from Baseline in HbA1c
Baseline, Week 208
Change from Baseline in Weight
Baseline, Week 104
Change from Baseline in Weight
Baseline, Week 208
Change from Baseline in Waist Circumference
Baseline, Week 104
Change from Baseline in Waist Circumference
Baseline, Week 208
- +28 more secondary outcomes
Study Arms (2)
Tirzepatide
EXPERIMENTALParticipants will receive tirzepatide at the maximum tolerated dose subcutaneously (SC)
Intensified Conventional Care Dose
ACTIVE COMPARATORParticipants will receive an antihyperglycemic medication
Interventions
Eligibility Criteria
You may qualify if:
- Have, within the last 4 years, been diagnosed with T2D based on the World Health Organization classification or other locally applicable diagnostic standards.
- Have HbA1c ≥7% to ≤9.5% as determined by the central laboratory.
- Have been on a stable treatment of metformin only at least 90 days preceding baseline
- with the minimum effective dose of ≥1500 mg/day, but not higher than the maximum approved dose per country-specific label, or
- \<1500 mg/day in case of intolerance of full therapeutic dose.
You may not qualify if:
- Have type 1 diabetes mellitus
- Have a history of chronic or acute pancreatitis any time prior to study entry
- Have a history of
- proliferative diabetic retinopathy
- diabetic macular edema, or
- no proliferative diabetic retinopathy requiring immediate or urgent treatment
- Are at high risk for cardiovascular disease (CVD) in the investigator's opinion or have a history of any of these CV conditions prior to study entry
- myocardial infarction
- percutaneous coronary revascularization procedure
- carotid stenting or surgical revascularization
- nontraumatic amputation
- peripheral vascular procedure (e.g., stenting or surgical revascularization)
- cerebrovascular accident (stroke), or congestive heart failure
- Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2)
- Have within 90 days prior to screening received treatment with medications intended to promote weight loss. This includes prescribed, over the counter, or alternative remedies
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (90)
Cahaba Research - Trussville
Birmingham, Alabama, 35235, United States
San Fernando Valley Health Institute
Canoga Park, California, 91304, United States
Velocity Clinical Research, Huntington Park
Huntington Park, California, 90255, United States
Velocity Clinical Research, San Diego
La Mesa, California, 91942, United States
Clinical Trials Research
Lincoln, California, 95648, United States
Velocity Clinical Research, Westlake
Los Angeles, California, 90057, United States
Catalina Research Institute, LLC
Montclair, California, 91763, United States
Velocity Clinical Research, North Hollywood
North Hollywood, California, 91606, United States
Velocity Clinical Research, Panorama City
Panorama City, California, 91402, United States
Western University of Health Sciences
Pomona, California, 91766, United States
Velocity Clinical Research, Santa Ana
Santa Ana, California, 92704, United States
New England Research Associates, LLC
Bridgeport, Connecticut, 06606, United States
Excel Medical Clinical Trials
Boca Raton, Florida, 33434, United States
Alliance for Multispecialty Research, LLC
Coral Gables, Florida, 33134, United States
South Florida Clinical Research Institute
Margate, Florida, 33063, United States
Emory University School of Medicine- Grady Campus
Atlanta, Georgia, 30303, United States
Center for Advanced Research & Education
Gainesville, Georgia, 30501, United States
Qualmedica Research, LLC
Evansville, Indiana, 47715, United States
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, 50265, United States
Qualmedica Research
Bowling Green, Kentucky, 42101, United States
NECCR PrimaCare Research
Fall River, Massachusetts, 02721, United States
SKY Integrative Medical Center/SKYCRNG
Ridgeland, Mississippi, 39157, United States
StudyMetrix Research
City of Saint Peters, Missouri, 63303, United States
Clinvest Research LLC
Springfield, Missouri, 65807, United States
Research Foundation of SUNY - University of Buffalo
Buffalo, New York, 14221, United States
Lucas Research, Inc
Morehead City, North Carolina, 28557, United States
The Corvallis Clinic, P.C.
Corvallis, Oregon, 97330, United States
Clinical Research of Philadelphia
Philadelphia, Pennsylvania, 19114, United States
Preferred Primary Care Physicians
Uniontown, Pennsylvania, 15401, United States
Tribe Clinical Research, LLC
Greenville, South Carolina, 29607, United States
Velocity Clinical Research, Spartanburg
Spartanburg, South Carolina, 29303, United States
Dallas Diabetes Research Center
Dallas, Texas, 75230, United States
Centro de Investigaciones Metabólicas (CINME)
Ciudad Autónoma de Buenos Aire, Buenos Aires, 1056, Argentina
Instituto de Investigaciones Clínicas Mar del Plata
Mar del Plata, Buenos Aires, 7600, Argentina
Go Centro Medico San Nicolás
San Nicolás de los Arroyos, Buenos Aires, 2900, Argentina
CIAD Moron
Morón, Buenos Air, B1708EPE, Argentina
Centro Médico Viamonte
Buenos Aires, Ciudad Aut, C1120AAC, Argentina
Dr. M.B. Jones Inc.
Victoria, British Columbia, V8V 4A1, Canada
Bluewater Clinical Research Group Inc.
Sarnia, Ontario, N7T 4X3, Canada
Stouffville Medical Centre
Stouffville, Ontario, L4A 1H2, Canada
9109-0126 Quebec Inc.
Montreal, Quebec, H4N 2W2, Canada
ClinPhenomics CVC GmbH
Frankfurt am Main, Hesse, 60596, Germany
Diabetes- und Stoffwechselpraxis Bochum
Bochum, North Rhine-Westphalia, 44869, Germany
InnoDiab Forschung Gmbh
Essen, North Rhine-Westphalia, 45136, Germany
Zentrum für klinische Studien
Saint Ingbert, Saarland, 66386, Germany
Arztpraxis Christine Kosch Pirna
Pirna, Saxony, 01796, Germany
RED-Institut GmbH
Oldenburg in Holstein, Schleswig-Holstein, 23758, Germany
Diabetespraxis Mergentheim
Bad Mergentheim, 97980, Germany
Diabetes Zentrum Dr. Tews
Gelnhausen, 63571, Germany
Edith Wolfson Medical Center
Holon, Central District, 5810001, Israel
Rabin Medical Center
Petah Tikva, Central District, 4941492, Israel
Sheba Medical Center
Ramat Gan, Central District, 5262100, Israel
Kaplan Medical Center
Rehovot, Central District, 7610001, Israel
Hadassah Medical Center
Jerusalem, Jerusalem, 9112001, Israel
Bnai Zion Medical Center
Haifa, Northern District, 3339419, Israel
Clalit Health Services - Sakhnin Community Clinic
Sakhnin, Northern District, 3081000, Israel
Clalit Health Services - Atlit
Atlit, Southern District, Israel
Linn Medical Center
Haifa, Ḥeifā, 3515209, Israel
A.O.U.C. Policlinico di Bari
Bari, Apulia, 70124, Italy
University of Naples Federico II
Naples, Campania, 80131, Italy
Centro Cardiologico Monzino
Milan, Milano, 20138, Italy
Ospedale Civile Santa Croce Pronto Soccorso
Moncalieri, Piedmont, 10024, Italy
Ospedale san Giovanni di Dio-Diabetologia
Olbia, Sardinia, 07026, Italy
A.O.U. Policlinico Paolo Giaccone
Palermo, Sicily, 90129, Italy
Azienda Ospedaliera Universitaria Pisana
Pisa, Tuscany, 56124, Italy
AOU Renato Dulbecco
Catanzaro, 88100, Italy
Private Practice - Dr. Arechavaleta Granell Maria del Rosario
Guadalajara, Jalisco, 44670, Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, Nuevo León, 66460, Mexico
Investigacion En Salud Y Metabolismo Sc
Chihuahua City, 31217, Mexico
San Juan Bautista School of Medicine - Clinical Research Unit
Caguas, PR, 00725, Puerto Rico
GCM Medical Group, PSC - Hato Rey Site
San Juan, PR, 00917, Puerto Rico
Dorado Medical Complex
Dorado, 00646, Puerto Rico
Diabdana
Oradea, Bihor County, 410147, Romania
C.M.D.T.A. Neomed
Brasov, Brașov County, 500283, Romania
Centrul Medical NutriLife
Bucharest, București, 013764, Romania
Gama Diamed
Mangalia, Constanța County, 905500, Romania
Diabmed Dr. Popescu Alexandrina
Ploieşti, Prahova, 100179, Romania
Milena Sante
Galați, 800001, Romania
Clinica Korall
Satu Mare, 440055, Romania
MEDIKALS
Piešťany, 921 01, Slovakia
ProDia s.r.o.
Považská Bystrica, 017 01, Slovakia
JAL
Trnava, 917 01, Slovakia
IRIDIA
Vrútky, Žilina Region, 038 61, Slovakia
Aberdeen Royal Infirmary
Aberdeen, Aberdeen City, AB25 2ZN, United Kingdom
Ninewells Hospital and Medical School
Dundee, Angus, DD1 9SY, United Kingdom
Staploe Medical Centre
Ely, Cambridgeshire, CB7 5JD, United Kingdom
Knowle House Surgery
Plymouth, Devon, PL5 3JB, United Kingdom
Hull Royal Infirmary
Hull, Kingston Upon Hull, HU3 2JZ, United Kingdom
Leicester General Hospital
Leicester, Leicestershire, LE5 4PW, United Kingdom
Wickersley Health Centre - Clifton Medical Centre
Rotherham, S65 1DA, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
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
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 22, 2022
First Posted
June 27, 2022
Study Start
August 1, 2022
Primary Completion
October 21, 2025
Study Completion (Estimated)
November 1, 2027
Last Updated
December 12, 2025
Record last verified: 2025-12
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.