SURPASS-EARLY

Active not recruitingPhase 4

A Study of Tirzepatide Compared With Intensified Conventional Care in Adult Participants With Type 2 Diabetes

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

Lead sponsor

Eli Lilly and Company

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

Recruiting sites

—

Enrollment

780

estimated

Study population

Type 2 diabetes

Key I/E criterion

•HbA1c 7-9.5%

Primary endpoint

•HbA1c, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05433584

Org study ID17205

Secondary ID2022-000130-42

Secondary ID2022-5010733-40-00EU Trial Number

Secondary IDI8F-MC-GPHEEli Lilly and Company

Secondary IDU1111-1282-0263World Health Organization

Timeline

Milestones

Study first posted2022-06-27actual

Study start2022-08-01actual

Primary completion2025-10-21actual

Last update posted2025-12-12actual

Study completion2027-11estimated (month precision)

Assets

Investigational agents

Tirzepatide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•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.

Exclusion criteria

•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

•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.

Endpoints (34)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes

Weight & body composition

Cardiometabolic biomarkers

Patient-reported / QoL

Weight & body composition

10 endpoints

Secondary/protocol endpoint

Change from Baseline in Weight

Time frame:Baseline, Week 104

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Weight

Time frame:Baseline, Week 208

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Waist Circumference

Time frame:Baseline, Week 104

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Waist Circumference

Time frame:Baseline, Week 208

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Weight loss of ≥5%,

Time frame:Baseline, Week 104

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Change from Baseline in Weight loss of ≥10%

Time frame:Baseline, Week 104

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Change from Baseline in Weight loss of ≥15%

Time frame:Baseline, Week 104

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Change from Baseline in Weight loss of ≥5%

Time frame:Baseline, Week 208

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Change from Baseline in Weight loss of ≥10%

Time frame:Baseline, Week 208

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Change from Baseline in Weight loss of ≥15%

Time frame:Baseline, Week 208

≥15% weight-loss responders

threshold achievement, improvement

Glycemic / diabetes

20 endpoints

Primary/protocol endpoint

Change from Baseline in Hemoglobin A1c (HbA1c)

Time frame:Baseline, Week 104

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change from Baseline in HbA1c

Time frame:Baseline, Week 208

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change from Baseline in Fasting Serum Glucose (FSG)

Time frame:Baseline, Week 104

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change from Baseline in FSG

Time frame:Baseline, Week 208

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Percentage of Participants Achieving HbA1c <7.0%

Time frame:Week 104

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participants Achieving HbA1c ≤6.5%

Time frame:Week 104

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participants Achieving HbA1c <5.7%

Time frame:Week 104

HbA1c <5.7% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participants Achieving HbA1c <7.0%

Time frame:Week 208

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participants Achieving HbA1c ≤6.5%

Time frame:Week 208

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participants Achieving HbA1c <5.7%

Time frame:Week 208

HbA1c <5.7% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

A Composite Endpoint of HbA1c, Weight loss and Hypoglycemia

Time frame:Week 104

threshold achievement, improvement

componentsHbA1c <6.5% achievement, ≥10% weight-loss responders, Documented hypoglycemia, Severe hypoglycemia

Secondary/protocol endpoint

A Composite Endpoint of HbA1c, Weight loss and Hypoglycemia

Time frame:Week 208

threshold achievement, improvement

componentsHbA1c <6.5% achievement, ≥10% weight-loss responders, Documented hypoglycemia, Severe hypoglycemia

Secondary/protocol endpoint/low confidence

Change from Baseline in β-cell Glucose Sensitivity

Time frame:Baseline, Week 104

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in β-cell glucose sensitivity

Time frame:Baseline, Week 208

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change from Baseline in Insulin Secretion Rate at a Fixed Glucose Concentration

Time frame:Baseline, Week 104

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Insulin Secretion Rate at a Fixed Glucose Concentration

Time frame:Baseline, Week 208

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Postprandial Insulin Sensitivity Indices

Time frame:Baseline, Week 104

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Postprandial Insulin Sensitivity Indices

Time frame:Baseline, Week 208

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Fasting and Post-challenge Glucose [total and incremental AUC(₀-₂₄₀min)]

Time frame:Baseline through Week 104

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Fasting and Post-challenge Glucose [total and incremental (AUC₀-₂₄₀min)]

Time frame:Baseline through Week 208

Postprandial glucose

change from baseline, improvement

Cardiometabolic biomarkers

2 endpoints

Secondary/protocol endpoint/low confidence

Change from Baseline in Lipids

Time frame:Baseline, Week 104

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change from Baseline in Lipids

Time frame:Baseline, Week 208

change from baseline, improvement

Patient-reported / QoL

2 endpoints

Secondary/protocol endpoint

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

IWQOL-Lite physical

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in the IWQOL-Lite-CT - Physical Functioning Domain

Time frame:Baseline, Week 208

IWQOL-Lite physical

change from baseline, improvement

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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 May 26. doi: 10.7326/ANNALS-25-05602. Online ahead of print.
PMID42184419via clinicaltrials gov reference derived

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.