Type 2 DiabetesPhase 4SURPASS-EARLYNCT05433584
A Study of Tirzepatide Compared With Intensified Conventional Care in Adult Participants With Type 2 Diabetes
A Phase 4 study testing Tirzepatide and Antihyperglycemic medication in people with Type 2 Diabetes, run by Eli Lilly and Company at 90 sites in 11 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Tirzepatide and Antihyperglycemic medication
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 780 participants
- Where
- 90 sitesin 11 countries
- Study dates
- 1 Aug 2022to Nov 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 18Show fewer
- 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
- Have an estimated glomerular filtration rate (eGFR) <30 mL/minute/1.73 m2 (or lower than the country-specific threshold for discontinuing metformin therapy per local label), calculated by chronic kidney disease-epidemiology equation as determined by central laboratory at screening.
- Have been treated with any injectable glucagon-like peptide-1 (GLP-1) receptor agonists and insulin prior to screening.
- Exception: use of insulin for gestational diabetes or short-term use (<14 days) for acute conditions such as acute illness, hospitalization, or elective surgery.
Trial locations and contacts
90 sites in 11 countries.
90 sites in 11 countries
United States32 sites
Emory University School of Medicine- Grady Campus
Atlanta, Georgia, 30303
Cahaba Research - Trussville
Birmingham, Alabama, 35235
Excel Medical Clinical Trials
Boca Raton, Florida, 33434
Qualmedica Research
Bowling Green, Kentucky, 42101
New England Research Associates, LLC
Bridgeport, Connecticut, 06606
Research Foundation of SUNY - University of Buffalo
Buffalo, New York, 14221
San Fernando Valley Health Institute
Canoga Park, California, 91304
StudyMetrix Research
City of Saint Peters, Missouri, 63303
Alliance for Multispecialty Research, LLC
Coral Gables, Florida, 33134
The Corvallis Clinic, P.C.
Corvallis, Oregon, 97330
Dallas Diabetes Research Center
Dallas, Texas, 75230
Qualmedica Research, LLC
Evansville, Indiana, 47715
NECCR PrimaCare Research
Fall River, Massachusetts, 02721
Center for Advanced Research & Education
Gainesville, Georgia, 30501
Tribe Clinical Research, LLC
Greenville, South Carolina, 29607
Velocity Clinical Research, Huntington Park
Huntington Park, California, 90255
Velocity Clinical Research, San Diego
La Mesa, California, 91942
Clinical Trials Research
Lincoln, California, 95648
Velocity Clinical Research, Westlake
Los Angeles, California, 90057
South Florida Clinical Research Institute
Margate, Florida, 33063
Catalina Research Institute, LLC
Montclair, California, 91763
Lucas Research, Inc
Morehead City, North Carolina, 28557
Velocity Clinical Research, North Hollywood
North Hollywood, California, 91606
Velocity Clinical Research, Panorama City
Panorama City, California, 91402
Clinical Research of Philadelphia
Philadelphia, Pennsylvania, 19114
Western University of Health Sciences
Pomona, California, 91766
SKY Integrative Medical Center/SKYCRNG
Ridgeland, Mississippi, 39157
Velocity Clinical Research, Santa Ana
Santa Ana, California, 92704
Velocity Clinical Research, Spartanburg
Spartanburg, South Carolina, 29303
Clinvest Research LLC
Springfield, Missouri, 65807
Preferred Primary Care Physicians
Uniontown, Pennsylvania, 15401
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, 50265
Israel9 sites
Clalit Health Services - Atlit
Atlit, Southern District
Bnai Zion Medical Center
Haifa, Northern District, 3339419
Linn Medical Center
Haifa, Ḥeifā, 3515209
Edith Wolfson Medical Center
Holon, Central District, 5810001
Hadassah Medical Center
Jerusalem, Jerusalem, 9112001
Rabin Medical Center
Petah Tikva, Central District, 4941492
Sheba Medical Center
Ramat Gan, Central District, 5262100
Kaplan Medical Center
Rehovot, Central District, 7610001
Clalit Health Services - Sakhnin Community Clinic
Sakhnin, Northern District, 3081000
Germany8 sites
Diabetespraxis Mergentheim
Bad Mergentheim, 97980
Diabetes- und Stoffwechselpraxis Bochum
Bochum, North Rhine-Westphalia, 44869
InnoDiab Forschung Gmbh
Essen, North Rhine-Westphalia, 45136
ClinPhenomics CVC GmbH
Frankfurt am Main, Hesse, 60596
Diabetes Zentrum Dr. Tews
Gelnhausen, 63571
RED-Institut GmbH
Oldenburg in Holstein, Schleswig-Holstein, 23758
Arztpraxis Christine Kosch Pirna
Pirna, Saxony, 01796
Zentrum für klinische Studien
Saint Ingbert, Saarland, 66386
Italy8 sites
A.O.U.C. Policlinico di Bari
Bari, Apulia, 70124
AOU Renato Dulbecco
Catanzaro, 88100
Centro Cardiologico Monzino
Milan, Milano, 20138
Ospedale Civile Santa Croce Pronto Soccorso
Moncalieri, Piedmont, 10024
University of Naples Federico II
Naples, Campania, 80131
Ospedale san Giovanni di Dio-Diabetologia
Olbia, Sardinia, 07026
A.O.U. Policlinico Paolo Giaccone
Palermo, Sicily, 90129
Azienda Ospedaliera Universitaria Pisana
Pisa, Tuscany, 56124
Romania7 sites
C.M.D.T.A. Neomed
Brasov, Brașov County, 500283
Centrul Medical NutriLife
Bucharest, Bucharest, 013764
Milena Sante
Galați, 800001
Gama Diamed
Mangalia, Constanța County, 905500
Diabdana
Oradea, Bihor County, 410147
Diabmed Dr. Popescu Alexandrina
Ploieşti, Prahova, 100179
Clinica Korall
Satu Mare, 440055
United Kingdom7 sites
Aberdeen Royal Infirmary
Aberdeen, Aberdeen City, AB25 2ZN
Ninewells Hospital and Medical School
Dundee, Angus, DD1 9SY
Staploe Medical Centre
Ely, Cambridgeshire, CB7 5JD
Hull Royal Infirmary
Hull, Kingston Upon Hull, HU3 2JZ
Leicester General Hospital
Leicester, Leicestershire, LE5 4PW
Knowle House Surgery
Plymouth, Devon, PL5 3JB
Wickersley Health Centre - Clifton Medical Centre
Rotherham, S65 1DA
Argentina5 sites
Centro Médico Viamonte
Buenos Aires, Ciudad Aut, C1120AAC
Centro de Investigaciones Metabólicas (CINME)
Ciudad Autónoma de Buenos Aire, Buenos Aires, 1056
Instituto de Investigaciones Clínicas Mar del Plata
Mar del Plata, Buenos Aires, 7600
CIAD Moron
Morón, Buenos Air, B1708EPE
Go Centro Medico San Nicolás
San Nicolás de los Arroyos, Buenos Aires, 2900
Canada4 sites
9109-0126 Quebec Inc.
Montreal, Quebec, H4N 2W2
Bluewater Clinical Research Group Inc.
Sarnia, Ontario, N7T 4X3
Stouffville Medical Centre
Stouffville, Ontario, L4A 1H2
Dr. M.B. Jones Inc.
Victoria, British Columbia, V8V 4A1
Slovakia4 sites
MEDIKALS
Piešťany, 921 01
ProDia s.r.o.
Považská Bystrica, 017 01
JAL
Trnava, 917 01
IRIDIA
Vrútky, Žilina Region, 038 61
Mexico3 sites
Investigacion En Salud Y Metabolismo Sc
Chihuahua City, 31217
Private Practice - Dr. Arechavaleta Granell Maria del Rosario
Guadalajara, Jalisco, 44670
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, Nuevo León, 66460
Puerto Rico3 sites
San Juan Bautista School of Medicine - Clinical Research Unit
Caguas, PR, 00725
Dorado Medical Complex
Dorado, 00646
GCM Medical Group, PSC - Hato Rey Site
San Juan, PR, 00917
About this study
Official title: 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
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.
- Conditions
- Type 2 Diabetes
- Being tested
- Tirzepatide, Antihyperglycemic medication
- Keywords
- T2D, Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TirzepatideDrug
Also called LY3298176
Administered SC
Antihyperglycemic medicationDrug
As prescribed
| Study group | Role | What they receive |
|---|---|---|
| Tirzepatide | Experimental | Participants will receive tirzepatide at the maximum tolerated dose subcutaneously (SC) Receives: Drug: Tirzepatide |
| Intensified Conventional Care Dose | Active comparator | Participants will receive an antihyperglycemic medication Receives: Drug: Antihyperglycemic medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Hemoglobin A1c (HbA1c)
Measured: Baseline, Week 104
Secondary outcomes (33)
Change from Baseline in HbA1c
Measured: Baseline, Week 208
Change from Baseline in Weight
Measured: Baseline, Week 104
Change from Baseline in Weight
Measured: Baseline, Week 208
Change from Baseline in Waist Circumference
Measured: Baseline, Week 104
Change from Baseline in Waist Circumference
Measured: Baseline, Week 208
Change from Baseline in Fasting Serum Glucose (FSG)
Measured: Baseline, Week 104
Change from Baseline in FSG
Measured: Baseline, Week 208
Change from Baseline in Lipids
Measured: Baseline, Week 104
Change from Baseline in Lipids
Measured: Baseline, Week 208
Percentage of Participants Achieving HbA1c <7.0%
Measured: Week 104
Percentage of Participants Achieving HbA1c ≤6.5%
Measured: Week 104
Percentage of Participants Achieving HbA1c <5.7%
Measured: Week 104
Percentage of Participants Achieving HbA1c <7.0%
Measured: Week 208
Percentage of Participants Achieving HbA1c ≤6.5%
Measured: Week 208
Percentage of Participants Achieving HbA1c <5.7%
Measured: Week 208
Change from Baseline in Weight loss of ≥5%,
Measured: Baseline, Week 104
Change from Baseline in Weight loss of ≥10%
Measured: Baseline, Week 104
Change from Baseline in Weight loss of ≥15%
Measured: Baseline, Week 104
Change from Baseline in Weight loss of ≥5%
Measured: Baseline, Week 208
Change from Baseline in Weight loss of ≥10%
Measured: Baseline, Week 208
Change from Baseline in Weight loss of ≥15%
Measured: Baseline, Week 208
A Composite Endpoint of HbA1c, Weight loss and Hypoglycemia
A composite endpoint defined as HbA1c ≤ 6.5%, weight loss ≥10%, no hypoglycemia, defined as blood glucose (BG) <54 milligram/deciliter (mg/dL) <3.0 millimole/liter (mmol/L) and/or severe hypoglycemia
Measured: Week 104
A Composite Endpoint of HbA1c, Weight loss and Hypoglycemia
A composite endpoint defined as HbA1c ≤ 6.5%, weight loss ≥10%, no hypoglycemia, defined as BG <54 mg/dL (<3.0 mmol/L) and/or severe hypoglycemia
Measured: Week 208
Change from Baseline in β-cell Glucose Sensitivity
β-cell Glucose Sensitivity assessed by Oral Glucose Tolerance Test (OGTT)
Measured: Baseline, Week 104
Change from Baseline in β-cell glucose sensitivity
Change from baseline in β-cell glucose sensitivity assessed by OGTT
Measured: Baseline, Week 208
Change from Baseline in Insulin Secretion Rate at a Fixed Glucose Concentration
Insulin Secretion Rate assessed by OGTT
Measured: Baseline, Week 104
Change from Baseline in Insulin Secretion Rate at a Fixed Glucose Concentration
Insulin Secretion Rate assessed by OGTT
Measured: Baseline, Week 208
Change from Baseline in Postprandial Insulin Sensitivity Indices
Postprandial Insulin Sensitivity Indices assessed by OGTT
Measured: Baseline, Week 104
Change from Baseline in Postprandial Insulin Sensitivity Indices
Postprandial Insulin Sensitivity Indices assessed by OGTT
Measured: Baseline, Week 208
Change from Baseline in Fasting and Post-challenge Glucose [total and incremental AUC(₀-₂₄₀min)]
Fasting and Post-challenge Glucose [total and incremental AUC(₀-₂₄₀min)] assessed by OGTT
Measured: Baseline through Week 104
Change from Baseline in Fasting and Post-challenge Glucose [total and incremental (AUC₀-₂₄₀min)]
Fasting and Post-challenge Glucose [total and incremental AUC(₀-₂₄₀min)] assessed by OGTT
Measured: Baseline through Week 208
Change from Baseline in the Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) - Physical Functioning Domain
Measured: Baseline, Week 104
Change from Baseline in the IWQOL-Lite-CT - Physical Functioning Domain
Measured: Baseline, Week 208
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start1 Aug 2022
- Primary completion21 Oct 2025
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 780 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05433584
- Sponsor's protocol ID
- 17205
- Other IDs
- I8F-MC-GPHE, 2022-000130-42, 2022-5010733-40-00, U1111-1282-0263
- Acronym
- SURPASS-EARLY
- Status last verified
- Dec 2025
- First submitted
- 22 Jun 2022
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Del Prato S, Heine RJ, Perez Manghi FC, Hsia SH, Gomez-Valderas E, Zeytinoglu M, Razzoli E, Kiljanski J, Sharma P, Knights A, Thieu VT. Tirzepatide Versus Intensified Conventional Care After 2 Years of Treatment in Early Type 2 Diabetes : A Randomized Clinical Trial. Ann Intern Med. 2026 Jul;179(7):917-928. doi: 10.7326/ANNALS-25-05602. Epub 2026 May 26.
PubMed 42184419
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05433584
- Acronym / sponsor ID
- SURPASS-EARLY / 17205
- Conditions
- Type 2 Diabetes
- Keywords
- T2D, Diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 780 participants (estimated)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 21 Oct 2025 (actual)
- Study completion
- Nov 2027 (estimated)
- First posted
- 27 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tirzepatide | Experimental | Drug: TirzepatideParticipants will receive tirzepatide at the maximum tolerated dose subcutaneously (SC) |
| Intensified Conventional Care Dose | Active comparator | Drug: Antihyperglycemic medicationParticipants will receive an antihyperglycemic medication |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (18 listed)
- Have type 1 diabetes mellitus
- Have a history of chronic or acute pancreatitis any time prior to study entry
- Have a history of
- 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
- Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TirzepatideAlso: LY3298176Administered SC | Drug | Tirzepatide |
| Antihyperglycemic medicationAs prescribed | Drug | Intensified Conventional Care Dose |
Primary outcome
Change from Baseline in Hemoglobin A1c (HbA1c)
Time frame: Baseline, Week 104
33 secondary outcomes
Change from Baseline in HbA1c
Time frame: Baseline, Week 208
Change from Baseline in Weight
Time frame: Baseline, Week 104
Change from Baseline in Weight
Time frame: Baseline, Week 208
Change from Baseline in Waist Circumference
Time frame: Baseline, Week 104
Change from Baseline in Waist Circumference
Time frame: Baseline, Week 208
Change from Baseline in Fasting Serum Glucose (FSG)
Time frame: Baseline, Week 104
Change from Baseline in FSG
Time frame: Baseline, Week 208
Change from Baseline in Lipids
Time frame: Baseline, Week 104
Change from Baseline in Lipids
Time frame: Baseline, Week 208
Percentage of Participants Achieving HbA1c <7.0%
Time frame: Week 104
Percentage of Participants Achieving HbA1c ≤6.5%
Time frame: Week 104
Percentage of Participants Achieving HbA1c <5.7%
Time frame: Week 104
Percentage of Participants Achieving HbA1c <7.0%
Time frame: Week 208
Percentage of Participants Achieving HbA1c ≤6.5%
Time frame: Week 208
Percentage of Participants Achieving HbA1c <5.7%
Time frame: Week 208
Change from Baseline in Weight loss of ≥5%,
Time frame: Baseline, Week 104
Change from Baseline in Weight loss of ≥10%
Time frame: Baseline, Week 104
Change from Baseline in Weight loss of ≥15%
Time frame: Baseline, Week 104
Change from Baseline in Weight loss of ≥5%
Time frame: Baseline, Week 208
Change from Baseline in Weight loss of ≥10%
Time frame: Baseline, Week 208
Change from Baseline in Weight loss of ≥15%
Time frame: Baseline, Week 208
A Composite Endpoint of HbA1c, Weight loss and Hypoglycemia
Time frame: Week 104
A Composite Endpoint of HbA1c, Weight loss and Hypoglycemia
Time frame: Week 208
Change from Baseline in β-cell Glucose Sensitivity
Time frame: Baseline, Week 104
Change from Baseline in β-cell glucose sensitivity
Time frame: Baseline, Week 208
Change from Baseline in Insulin Secretion Rate at a Fixed Glucose Concentration
Time frame: Baseline, Week 104
Change from Baseline in Insulin Secretion Rate at a Fixed Glucose Concentration
Time frame: Baseline, Week 208
Change from Baseline in Postprandial Insulin Sensitivity Indices
Time frame: Baseline, Week 104
Change from Baseline in Postprandial Insulin Sensitivity Indices
Time frame: Baseline, Week 208
Change from Baseline in Fasting and Post-challenge Glucose [total and incremental AUC(₀-₂₄₀min)]
Time frame: Baseline through Week 104
Change from Baseline in Fasting and Post-challenge Glucose [total and incremental (AUC₀-₂₄₀min)]
Time frame: Baseline through Week 208
Change from Baseline in the Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) - Physical Functioning Domain
Time frame: Baseline, Week 104
Change from Baseline in the IWQOL-Lite-CT - Physical Functioning Domain
Time frame: Baseline, Week 208
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Derived from this study: PubMed 42184419Del Prato S, Heine RJ, Perez Manghi FC, Hsia SH, Gomez-Valderas E, Zeytinoglu M, Razzoli E, Kiljanski J, Sharma P, Knights A, Thieu VT. Tirzepatide Versus Intensified Conventional Care After 2 Years of Treatment in Early Type 2 Diabetes : A Randomized Clinical Trial. Ann Intern Med. 2026 Jul;179(7):917-928. doi: 10.7326/ANNALS-25-05602. Epub 2026 May 26.
- A Study of Tirzepatide Compared With Intensified Conventional Care in Adult Participants With Type 2 Diabetes (SURPASS-EARLY)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
90 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tirzepatide and Antihyperglycemic medication in people with Type 2 Diabetes, run by Eli Lilly and Company at 90 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 90 sites in United States, Israel, Germany, Italy, Romania and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Hemoglobin A1c (HbA1c) (time frame: Baseline, Week 104). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05433584, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.