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Study · Randomized controlled trial · n = 13,165 · 2026

10 results

Cardiorenal Outcomes With Tirzepatide Compared With Dulaglutide in Patients With Diabetes and Cardiovascular Disease: A Post Hoc Analysis of the SURPASS-CVOT Randomized Clinical Trial.

Nissen SE, Wolski K, D'Alessio D, Weerakkody G, Kiljanski J, Wiese RJ, Pavo I, Cariou B, Nicholls SJ

JAMA cardiology1 Jun 2026Cited by 6 (Europe PMC)

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: CC BY-NC-ND. Results still quote short attributed sentences.

Results from this study10

10 results from studies that gave the peptide. 10 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In patients with type 2 diabetes and cardiovascular disease, tirzepatide reduced the 6-component cardiorenal composite versus dulaglutide (HR 0.84; 23.7% versus 27.4%).

    In plain wordsIn adults with diabetes and heart disease, tirzepatide led to fewer serious heart and kidney events than dulaglutide (23.7% versus 27.4%).

    Outcome
    DecreaseSix-component cardiorenal composite
    Study

    n = 13,165

    Comparator
    Dulaglutide 1.5 mg
    Analysis
    Primary
    Outcome group
    Cardiovascular events · Cardiovascular
    Studied dose
    up to 15 mg weekly · subcutaneous · median 46.9 monthsAs given in this study (human).

    Measurements

    HR
    0.84 ratio
    6-component composite vs dulaglutide
    event rate
    23.7%
    tirzepatide
    event rate
    27.4%
    dulaglutide

    Source sentences

    Summary
    After a median (IQR) treatment duration of 46.9 (34.6-50.6) months, the primary cardiorenal end point occurred in 1559 tirzepatide-treated patients (23.7%) and 1803 dulaglutide-treated patients (27.4%; hazard ratio [HR], 0.84; 95% CI, 0.79-0.90; P < .001).
    2 context sentences
    Summary · context
    This parallel-design double-blind trial enrolled patients with diabetes and preexisting cardiovascular disease (from May 29, 2020, to June 27, 2022) at 640 centers in North and South America, Europe, Asia, and Oceania.
    Summary · context
    Participants were randomized to receive subcutaneous tirzepatide up to 15 mg (n = 6586) or a fixed dose of dulaglutide, 1.5 mg (n = 6579), administered weekly.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In patients with diabetes and cardiovascular disease, dulaglutide had more six-component cardiorenal events than tirzepatide.

    In plain wordsIn patients with diabetes and heart disease, dulaglutide had more combined heart, kidney, or death events than tirzepatide.

    Outcome
    IncreaseSix-component cardiorenal composite
    Study

    n = 13,165

    Comparator
    Tirzepatide up to 15 mg
    Analysis
    Primary
    Outcome group
    Cardiovascular events · Cardiovascular
    Studied dose
    1.5 mg weekly · subcutaneous · median treatment duration 46.9 monthsAs given in this study (human).

    Measurements

    patients with primary cardiorenal end point, dulaglutide
    1803 patients
    dulaglutide 1.5 mg
    proportion with primary cardiorenal end point, dulaglutide
    27.4%
    dulaglutide 1.5 mg
    patients with primary cardiorenal end point, tirzepatide
    1559 patients
    tirzepatide up to 15 mg
    proportion with primary cardiorenal end point, tirzepatide
    23.7%
    tirzepatide up to 15 mg
    hazard ratio, primary cardiorenal end point
    0.84 HR
    tirzepatide versus dulaglutide
    95% CI of hazard ratio
    0.79 to 0.9 HR
    tirzepatide versus dulaglutide

    Source sentences

    Summary
    After a median (IQR) treatment duration of 46.9 (34.6-50.6) months, the primary cardiorenal end point occurred in 1559 tirzepatide-treated patients (23.7%) and 1803 dulaglutide-treated patients (27.4%; hazard ratio [HR], 0.84; 95% CI, 0.79-0.90; P < .001).
    2 context sentences
    Summary · context
    This parallel-design double-blind trial enrolled patients with diabetes and preexisting cardiovascular disease (from May 29, 2020, to June 27, 2022) at 640 centers in North and South America, Europe, Asia, and Oceania.
    Summary · context
    Participants were randomized to receive subcutaneous tirzepatide up to 15 mg (n = 6586) or a fixed dose of dulaglutide, 1.5 mg (n = 6579), administered weekly.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In patients with type 2 diabetes and cardiovascular disease, a sensitivity analysis found that tirzepatide reduced the 5-component composite versus dulaglutide (HR 0.86).

    In plain wordsIn adults with diabetes and heart disease, tirzepatide led to fewer heart events than dulaglutide in a check that left out kidney events.

    Outcome
    DecreaseFive-component composite without kidney outcomes
    Study

    n = 13,165

    Comparator
    Dulaglutide 1.5 mg
    Outcome group
    Cardiovascular events · Cardiovascular
    Studied dose
    up to 15 mg weekly · subcutaneous · median 46.9 monthsAs given in this study (human).

    Measurements

    HR
    0.86 ratio
    5-component composite vs dulaglutide

    Source sentences

    Summary
    Sensitivity analyses showed similar hazard ratios for a narrower 5-component end point (without the kidney composite outcomes: HR, 0.86; 95% CI, 0.80-0.93) and the 4-component composite (without either kidney or heart failure end points: HR, 0.86; 95% CI, 0.80-0.93).
    2 context sentences
    Summary · context
    This parallel-design double-blind trial enrolled patients with diabetes and preexisting cardiovascular disease (from May 29, 2020, to June 27, 2022) at 640 centers in North and South America, Europe, Asia, and Oceania.
    Summary · context
    Participants were randomized to receive subcutaneous tirzepatide up to 15 mg (n = 6586) or a fixed dose of dulaglutide, 1.5 mg (n = 6579), administered weekly.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In patients with type 2 diabetes and cardiovascular disease, a sensitivity analysis found that tirzepatide reduced the 4-component composite versus dulaglutide (HR 0.86).

    In plain wordsIn adults with diabetes and heart disease, tirzepatide led to fewer heart events than dulaglutide when kidney and heart failure events were left out.

    Outcome
    DecreaseFour-component composite without kidney or heart failure outcomes
    Study

    n = 13,165

    Comparator
    Dulaglutide 1.5 mg
    Outcome group
    Cardiovascular events · Cardiovascular
    Studied dose
    up to 15 mg weekly · subcutaneous · median 46.9 monthsAs given in this study (human).

    Measurements

    HR
    0.86 ratio
    4-component composite vs dulaglutide

    Source sentences

    Summary
    Sensitivity analyses showed similar hazard ratios for a narrower 5-component end point (without the kidney composite outcomes: HR, 0.86; 95% CI, 0.80-0.93) and the 4-component composite (without either kidney or heart failure end points: HR, 0.86; 95% CI, 0.80-0.93).
    2 context sentences
    Summary · context
    This parallel-design double-blind trial enrolled patients with diabetes and preexisting cardiovascular disease (from May 29, 2020, to June 27, 2022) at 640 centers in North and South America, Europe, Asia, and Oceania.
    Summary · context
    Participants were randomized to receive subcutaneous tirzepatide up to 15 mg (n = 6586) or a fixed dose of dulaglutide, 1.5 mg (n = 6579), administered weekly.
  5. 05HumanRandomized controlled trialSafety outcome

    In patients with type 2 diabetes and cardiovascular disease, gastrointestinal adverse events were more common with tirzepatide (42.5%) than with dulaglutide (35.9%).

    In plain wordsIn adults with diabetes and heart disease, tirzepatide caused more digestive side effects than dulaglutide (42.5% versus 35.9%).

    Outcome
    IncreaseGastrointestinal adverse events
    Study

    n = 13,165

    Comparator
    Dulaglutide 1.5 mg
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    up to 15 mg weekly · subcutaneous · median 46.9 monthsAs given in this study (human).

    Measurements

    GI adverse events
    42.5%
    tirzepatide
    GI adverse events
    35.9%
    dulaglutide

    Source sentences

    Summary
    Gastrointestinal adverse events were more common with tirzepatide (2827 patients [42.5%]) than dulaglutide (2387 patients [35.9%]) treatment.
    2 context sentences
    Summary · context
    This parallel-design double-blind trial enrolled patients with diabetes and preexisting cardiovascular disease (from May 29, 2020, to June 27, 2022) at 640 centers in North and South America, Europe, Asia, and Oceania.
    Summary · context
    Participants were randomized to receive subcutaneous tirzepatide up to 15 mg (n = 6586) or a fixed dose of dulaglutide, 1.5 mg (n = 6579), administered weekly.
  6. 06HumanRandomized controlled trialSafety outcome

    In patients with type 2 diabetes and cardiovascular disease, adverse events other than gastrointestinal ones were similar between tirzepatide and dulaglutide.

    In plain wordsIn adults with diabetes and heart disease, other side effects were similar for tirzepatide and dulaglutide.

    Outcome
    No significant changeOther adverse events
    Study

    n = 13,165

    Comparator
    Dulaglutide 1.5 mg
    Outcome group
    Adverse events · Whole body
    Studied dose
    up to 15 mg weekly · subcutaneous · median 46.9 monthsAs given in this study (human).

    Source sentences

    Summary
    Other adverse events were similar.
    2 context sentences
    Summary · context
    This parallel-design double-blind trial enrolled patients with diabetes and preexisting cardiovascular disease (from May 29, 2020, to June 27, 2022) at 640 centers in North and South America, Europe, Asia, and Oceania.
    Summary · context
    Participants were randomized to receive subcutaneous tirzepatide up to 15 mg (n = 6586) or a fixed dose of dulaglutide, 1.5 mg (n = 6579), administered weekly.
  7. 07HumanRandomized controlled trialEfficacy outcome

    In patients with diabetes and cardiovascular disease, the five-component event hazard was higher with dulaglutide than tirzepatide.

    In plain wordsIn patients with diabetes and heart disease, the five-component event risk was higher with dulaglutide than tirzepatide.

    Outcome
    IncreaseFive-component composite
    Study

    n = 13,165

    Comparator
    Tirzepatide up to 15 mg
    Outcome group
    Cardiovascular events · Cardiovascular
    Studied dose
    1.5 mg weekly · subcutaneous · median treatment duration 46.9 monthsAs given in this study (human).

    Measurements

    hazard ratio, 5-component end point
    0.86 HR
    tirzepatide versus dulaglutide
    95% CI of hazard ratio
    0.8 to 0.93 HR
    tirzepatide versus dulaglutide

    Source sentences

    Summary
    Sensitivity analyses showed similar hazard ratios for a narrower 5-component end point (without the kidney composite outcomes: HR, 0.86; 95% CI, 0.80-0.93) and the 4-component composite (without either kidney or heart failure end points: HR, 0.86; 95% CI, 0.80-0.93).
    2 context sentences
    Summary · context
    This parallel-design double-blind trial enrolled patients with diabetes and preexisting cardiovascular disease (from May 29, 2020, to June 27, 2022) at 640 centers in North and South America, Europe, Asia, and Oceania.
    Summary · context
    Participants were randomized to receive subcutaneous tirzepatide up to 15 mg (n = 6586) or a fixed dose of dulaglutide, 1.5 mg (n = 6579), administered weekly.
  8. 08HumanRandomized controlled trialEfficacy outcome

    In patients with diabetes and cardiovascular disease, the four-component event hazard was higher with dulaglutide than tirzepatide.

    In plain wordsIn patients with diabetes and heart disease, the four-component event risk was higher with dulaglutide than tirzepatide.

    Outcome
    IncreaseFour-component composite
    Study

    n = 13,165

    Comparator
    Tirzepatide up to 15 mg
    Outcome group
    Cardiovascular events · Cardiovascular
    Studied dose
    1.5 mg weekly · subcutaneous · median treatment duration 46.9 monthsAs given in this study (human).

    Measurements

    hazard ratio, 4-component end point
    0.86 HR
    tirzepatide versus dulaglutide
    95% CI of hazard ratio
    0.8 to 0.93 HR
    tirzepatide versus dulaglutide

    Source sentences

    Summary
    Sensitivity analyses showed similar hazard ratios for a narrower 5-component end point (without the kidney composite outcomes: HR, 0.86; 95% CI, 0.80-0.93) and the 4-component composite (without either kidney or heart failure end points: HR, 0.86; 95% CI, 0.80-0.93).
    2 context sentences
    Summary · context
    This parallel-design double-blind trial enrolled patients with diabetes and preexisting cardiovascular disease (from May 29, 2020, to June 27, 2022) at 640 centers in North and South America, Europe, Asia, and Oceania.
    Summary · context
    Participants were randomized to receive subcutaneous tirzepatide up to 15 mg (n = 6586) or a fixed dose of dulaglutide, 1.5 mg (n = 6579), administered weekly.
  9. 09HumanRandomized controlled trialSafety outcome

    In patients with diabetes and cardiovascular disease, gastrointestinal adverse events were less common with dulaglutide than tirzepatide.

    In plain wordsIn patients with diabetes and heart disease, dulaglutide caused fewer digestive side effects than tirzepatide.

    Outcome
    DecreaseGastrointestinal adverse events
    Study

    n = 13,165

    Comparator
    Tirzepatide up to 15 mg
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    1.5 mg weekly · subcutaneous · median treatment duration 46.9 monthsAs given in this study (human).

    Measurements

    patients with gastrointestinal adverse events, dulaglutide
    2387 patients
    dulaglutide 1.5 mg
    proportion with gastrointestinal adverse events, dulaglutide
    35.9%
    dulaglutide 1.5 mg
    patients with gastrointestinal adverse events, tirzepatide
    2827 patients
    tirzepatide up to 15 mg
    proportion with gastrointestinal adverse events, tirzepatide
    42.5%
    tirzepatide up to 15 mg

    Source sentences

    Summary
    Gastrointestinal adverse events were more common with tirzepatide (2827 patients [42.5%]) than dulaglutide (2387 patients [35.9%]) treatment.
    2 context sentences
    Summary · context
    This parallel-design double-blind trial enrolled patients with diabetes and preexisting cardiovascular disease (from May 29, 2020, to June 27, 2022) at 640 centers in North and South America, Europe, Asia, and Oceania.
    Summary · context
    Participants were randomized to receive subcutaneous tirzepatide up to 15 mg (n = 6586) or a fixed dose of dulaglutide, 1.5 mg (n = 6579), administered weekly.
  10. 10HumanRandomized controlled trialSafety outcome

    In patients with diabetes and cardiovascular disease, other adverse events were similar with dulaglutide and tirzepatide.

    In plain wordsIn patients with diabetes and heart disease, other side effects were similar with dulaglutide and tirzepatide.

    Outcome
    No significant changeOther adverse events
    Study

    n = 13,165

    Comparator
    Tirzepatide up to 15 mg
    Outcome group
    Adverse events · Whole body
    Studied dose
    1.5 mg weekly · subcutaneous · median treatment duration 46.9 monthsAs given in this study (human).

    Source sentences

    Summary
    Other adverse events were similar.
    2 context sentences
    Summary · context
    This parallel-design double-blind trial enrolled patients with diabetes and preexisting cardiovascular disease (from May 29, 2020, to June 27, 2022) at 640 centers in North and South America, Europe, Asia, and Oceania.
    Summary · context
    Participants were randomized to receive subcutaneous tirzepatide up to 15 mg (n = 6586) or a fixed dose of dulaglutide, 1.5 mg (n = 6579), administered weekly.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT04255433

A Study of Tirzepatide (LY3298176) Compared With Dulaglutide on Major Cardiovascular Events in Participants With Type 2 Diabetes

Eli Lilly and Companyn = 13,29929 May 2020 to 12 Jun 2025

Type 2 Diabetes Mellitus

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Versions 4 to 8Current

    28 Oct 2026, 02:03 UTC

    The same notice was added 5 times, first on 22 Oct 2026, 02:26 UTC. The status did not change between them.

    Study results updated

  2. Version 3

    21 Oct 2026, 18:59 UTC

    Study data updated · source update from Europe PMC

  3. Version 2

    12 Oct 2026, 12:10 UTC

    Study results updated

  4. Version 1

    9 Oct 2026, 03:07 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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