What SURPASS-CVOT measured first
| Tirzepatide (MTD)n=6,586 | 1.5 mg Dulaglutiden=6,579 |
|---|---|
| 801 | 862 |
The Effect of Tirzepatide Versus Dulaglutide on Major Adverse Cardiovascular Events in Patients With Type 2 Diabetes (SURPASS-CVOT)
Number of Participants From Randomization to First Occurrence of Death From MACE-3 [Composite Endpoint of Major Adverse Cardiovascular Events Death From Cardiovascular Causes, Myocardial Infarction (MI) or Stroke] (participants), From randomization (week 0) up to week 259. Tirzepatide (MTD): 801; 1.5 mg Dulaglutide: 862.
As posted on ClinicalTrials.gov (NCT04255433), updated at source Jul 8, 2026. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.
| Tirzepatide (MTD)n=6,586 | 1.5 mg Dulaglutiden=6,579 |
|---|---|
| 801 | 862 |
Percent of participants affected, Baseline Up to 259 Weeks. The most common events the registry lists.
| Event | Tirzepatide (MTD) | 1.5 mg Dulaglutide |
|---|---|---|
| Any serious event | 31.8% | 31.9% |
| Nausea | 25% | 22.3% |
| Diarrhoea | 24.7% | 18.9% |
| Decreased appetite | 17.1% | 9.7% |
| Covid-19 | 15.7% | 15.1% |
| Constipation | 12.6% | 11.6% |
| Vomiting | 11.4% | 9.6% |
| Dyspepsia | 9.9% | 8.1% |
| Urinary tract infection | 6.6% | 7% |
| Weight decreased | 7% | 1.8% |
| Dizziness | 7% | 6.1% |
| Arthralgia | 6.1% | 6.3% |
| Cataract | 5.6% | 6% |
| Hypertension | 4.8% | 5.8% |
| Nasopharyngitis | 5.7% | 5.7% |
| Back pain | 5.7% | 5.6% |
| Hypotension | 5.7% | 3.1% |
| Eructation | 5.4% | 3.7% |
| Asthenia | 5.2% | 3.2% |
| Gastrooesophageal reflux disease | 5.1% | 4.5% |
| Tirzepatide (MTD)n=6,586 | 1.5 mg Dulaglutiden=6,579 |
|---|---|
| 566 | 669 |
| Tirzepatide (MTD)n=6,586 | 1.5 mg Dulaglutiden=6,579 |
|---|---|
| 367 | 408 |
| Tirzepatide (MTD)n=6,586 | 1.5 mg Dulaglutiden=6,579 |
|---|---|
| 311 | 357 |
| Tirzepatide (MTD)n=6,586 | 1.5 mg Dulaglutiden=6,579 |
|---|---|
| 229 | 249 |
| Tirzepatide (MTD)n=6,586 | 1.5 mg Dulaglutiden=6,579 |
|---|---|
| 1089 | 1217 |
| Tirzepatide (MTD)n=6,586 | 1.5 mg Dulaglutiden=6,579 |
|---|---|
| 512 | 557 |
| Tirzepatide (MTD)n=6,586 | 1.5 mg Dulaglutiden=6,579 |
|---|---|
| 527 | 617 |
| Tirzepatide (MTD)n=6,586 | 1.5 mg Dulaglutiden=6,579 |
|---|---|
| 373 | 442 |
| Tirzepatide (MTD)n=1,520 | 1.5 mg Dulaglutiden=1,403 |
|---|---|
| -5.72(0.437) | -8.90(0.393) |
| Tirzepatide (MTD)n=6,586 | 1.5 mg Dulaglutiden=6,579 |
|---|---|
| -1.66(0.0211) | -0.88(0.0235) |
| Tirzepatide (MTD)n=6,586 | 1.5 mg Dulaglutiden=6,578 |
|---|---|
| -11.6(0.122) | -4.82(0.0995) |
| Tirzepatide (MTD)n=6,472 | 1.5 mg Dulaglutiden=6,482 |
|---|---|
| -26.42(1.202) | -7.23(1.641) |
The purpose of the trial is to assess the efficacy and safety of tirzepatide to dulaglutide in participants with type 2 diabetes and increased cardiovascular risk.
Inclusion Criteria: * Men or women at least 40 years old with a diagnosis of type 2 diabetes * Established cardiovascular disease, including at least 1 of the following: * Coronary artery disease (CAD) with any of the following: * Documented history of spontaneous myocardial infarction (MI) * ≥50% stenosis in 1 or more major coronary arteries, determined by invasive angiography * ≥50% stenosis in 2 or more major coronary arteries, determined by computed tomography coronary angiography (CTCA) * History of surgical or percutaneous coronary revascularization procedure * Cerebrovascular disease - any of the following: * Documented history of ischemic stroke * Carotid arterial disease with ≥50% stenosis, documented by carotid ultrasound, magnetic resonance imaging (MRI), or angiography * Carotid stenting or surgical revascularization * Peripheral arterial disease with either of the following: * Intermittent claudication and ankle-brachial index \<0.9 * Prior nontraumatic amputation or peripheral vascular procedure (eg, stenting or surgical revascularization), due to peripheral arterial ischemia * Note: Supporting medical documentation is required in all instances * HbA1c ≥7% (≥53 mmol/mol) and ≤10.5% (≤91.3 mmol/mol) based on central laboratory assessment at screening * Body mass index (BMI) ≥25 kg/m2 * At the time of signing the informed consent: Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical trials. * Male patients: Men, regardless of their fertility status, with nonpregnant women of childbearing potential (WOCBP) partners must agree to either remain abstinent (if this is their preferred and usual lifestyle) or use condoms, as well as 1 additional highly effective (less than 1% failure rate) method of contraception (such as combination oral contraceptives, implanted contraceptives, or intrauterine devices) or effective method of contraception (such as diaphragms with spermicide or cervical sponges) for the duration of the study and until their plasma concentrations are below the level that could result in a relevant potential exposure to a possible fetus, predicted to be 90 days following the last dose of study drug. * Men and their partners may choose to use a double-barrier method of contraception. (Barrier protection methods without concomitant use of a spermicide are not an effective or acceptable method of contraception. Thus, each barrier method must include use of a spermicide. It should be noted, however, that the use of male and female condoms as a double barrier method is not considered acceptable due to the high failure rate when these barrier methods are combined). * Periodic abstinence (eg, calendar, ovulation, symptothermal, or postovulation methods), declaration of abstinence just for the duration of a trial, and withdrawal are not acceptable methods of contraception....
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.