Direct study · 2025

SURPASS-CVOT

Cardiovascular Outcomes with Tirzepatide versus Dulaglutide in Type 2 Diabetes.

Nicholls SJ, Pavo I, Bhatt DL, Buse JB, Del Prato S, Kahn SE, Lincoff AM, McGuire DK, Miller D, Nauck MA, Nishiyama H, Nissen SE, Sattar N, Weerakkody G, Wiese RJ, Zinman B, Zoungas S, Basile J, Davies MJ, Giorgino F, Kellerer M, Ji L, Varkonyi T, Menon V, Broder JC, Herschtal A, D'Alessio D, SURPASS-CVOT Investigators. · The New England journal of medicine

Study record

Population: 13,165 patients in the modified intention-to-treat analysis with type 2 diabetes and atherosclerotic cardiovascular disease.
Read source · Abstract-level extractionPrimary abstract — Methods and Results
Formulation: The protocol specifies sponsor-supplied tirzepatide investigational single fixed-dose pens and matched dulaglutide single-dose pens with identical volume and appearance. This describes the blinded trial presentation, not equivalence to research products or verification of every administered batch.
Read source · Study protocolProtocol Sections 7.1.2–7.1.4, printed page 52 (PDF page 53)
Route: Subcutaneous injection.
Read source · Abstract-level extractionPrimary abstract — Methods and Results
Dose & frequency: Tirzepatide up to 15 mg versus dulaglutide 1.5 mg weekly.
Read source · Abstract-level extractionPrimary abstract — Methods and Results
Study design: Double-blind randomized noninferiority comparison with dulaglutide.
Read source · Abstract-level extractionPrimary abstract — Methods and Results
Duration: Registry primary endpoint observation: up to week 259; this is not median follow-up.
Read source · Registry resultsResults — primary outcome time frame
Reported findings: Major cardiovascular events: 801/6586 versus 862/6579; HR 0.92 (95.3% CI 0.83–1.01). Noninferiority p=0.003; superiority p=0.09.
Read source · Abstract-level extractionPrimary abstract — Methods and Results
Adverse events: More gastrointestinal adverse events with tirzepatide.
Read source · Abstract-level extractionPrimary abstract — Methods and Results
Monitoring: The protocol required recording adverse events and separate adjudication of potential cardiovascular endpoints. Serious endpoint events used a separate endpoint-reporting process; they were additionally reported on the serious-adverse-event form when considered possibly treatment-, device- or procedure-related. Investigators followed medically important events, but were not required to actively seek new events after study completion or withdrawal. This describes planned ascertainment, not a personal monitoring schedule.
Read source · Study protocolProtocol Sections 9.2–9.2.1.1.1, printed pages 64–67

What it supports

Addresses SURPASS-CVOT outcomes in its specified population and comparison.

What it does not establish

Did not establish superiority or a placebo-relative effect. Registry safety denominators differ from the efficacy population. Abstract/registry extraction; unverified full-text details remain flagged.

Funding

Eli Lilly funded the study (primary abstract).

Publication and registry context

The registry agrees on 801/6586 versus 862/6579 participants with a first major cardiovascular event. This composite includes nonfatal myocardial infarction and stroke; it is not a count of cardiovascular deaths alone. Registry serious events through week 259 were 2117/6647 versus 2121/6647. Mortality denominators (6648 and 6651) and the efficacy denominators differ. The publication did not establish cardiovascular superiority.

Inspect NCT04255433 results

Literature search cutoff: 2026-09-08 · Not independently clinically reviewed

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