Type 2 DiabetesNCT06779929
Comparative Study of Tirzepatide Versus Dulaglutide (SURPASS CVOT) or Semaglutide on Major Cardiovascular Events in Participants With Type 2 Diabetes
An observational study of Type 2 Diabetes, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
This cohort study was initiated to emulate the design of the SURPASS-CVOT trial using observational analogues of the trial design components in a study based on insurance claims data. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Tirzepatide, Dulaglutide and Semaglutide
- How many people
- 70,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2024to 1 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 40 years and older
- All sexes
- Adult, Older adult
Study population: Patients > 40 years old with T2D and established atherosclerotic cardiovascular disease.
Who may be able to join
- Patients with T2D who were new users of tirzepatide or new users of dulaglutide
- AND established ASCVD defined as:
- History of Myocardial Infarction (MI) or MI sequela
- Unstable or stable angina
- Coronary atherosclerosis disease or procedures
- Ischemic stroke
Show all 11Show fewer
- Peripheral arterial disease or procedures
- Atherosclerotic cerebrovascular disease or cerebrovascular procedures
- Lower-limb amputation
- Age >= 40 years old
- Patients with at least 180 days of continuous health plan enrollment before and including the treatment initiation date
Who cannot join
- Patients with Type 1 diabetes mellitus
- Patients with missing age or sex information
- Patients with history of proliferative diabetic retinopathy, panretinal photocoagulation, vitreous hemorrhage, or intravitreal anti-VEGF injection
- Patient within history of left ventricular assisted device (LVAD) or heart transplant
- Patients with any previous organ transplants
- Patients with acute of chronic pancreatitis
Show all 19Show fewer
- Patients with gastroparesis, bowel obstruction or bariatric surgery
- Patient with CKD Stage 5, end stage kidney disease, kidney transplant, or hemodialysis
- Patients with multiple endocrine neoplasm syndrome type 2 (MEN-2)
- Patient with cancer
- Pregnant women
- Patient with diabetic ketoacidosis or HONK within the last year to treatment initiation
- Patients with acute hepatitis within the last year to treatment initiation
- Patients with elevated serum calcitonin level within the last year to treatment initiation
- Previous exposure to GLP-1RA or pramlintide during the 180-days washout period and including treatment initiation date
- Patients with severe hypoglycemia within the last 6 months to treatment initiation
- Patients with hospitalization for heart failure within the last 60 days to treatment initiation
- Patient with acute coronary syndrome, ischemic stroke, peripheral arterial disease, or coronary or cerebrovascular procedure within the last 60 days to treatment initiation
- Patients with prescription dispensing for both tirzepatide and dulaglutide on treatment initiation date
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02120
About this study
Official title: Comparative Study of Tirzepatide vs Dulaglutide (SURPASS CVOT) or Semaglutide on Major Cardiovascular Events in Participants With Type 2 Diabetes
This cohort study was initiated to emulate the design of the SURPASS-CVOT trial using observational analogues of the trial design components in a study based on insurance claims data.
Read the detailed description
Recent evidence suggests that the metabolic effects of glucagon-like peptide-1 receptor agonists (GLP-1RA) can be enhanced by combining them with the actions of other entero-pancreatic hormones, such as glucose-dependent insulinotropic polypeptide (GIP) and/or glucagon. Tirzepatide is a once-weekly GIP/GLP-1RA, approved for the treatment of type 2 diabetes in May 2022.
The Study of Tirzepatide Compared With Dulaglutide on Major Cardiovascular Events in Participants With Type 2 Diabetes (SURPASS-CVOT; NCT04255433) is an event-driven, randomized, double- blind, active comparator, parallel-group study, to evaluate cardiovascular (CV) outcomes with tirzepatide treatment in people with type 2 diabetes (T2D) and established atherosclerotic CV disease (ASCVD) compared with dulaglutide treatment, stratified by baseline sodium-glucose cotransporter-2 (SGLT2) inhibitors use. SURPASS-CVOT was designed to establish CV protection with tirzepatide by demonstrating noninferiority of tirzepatide to dulaglutide, and also to determine whether tirzepatide produces a greater CV benefit than dulaglutide (superiority analysis).
This new user active comparator cohort study aims to emulate the SURPASS-CVOT trial using insurance claims data. Trial design parameters were adapted in claims data using observational analogues for eligibility criteria, treatment strategies, treatment assignment, follow-up start, follow-up end, outcome, and causal contrast. We also conducted HbA1c-adjusted analyses among those with HbA1c values (54% of population).
- Conditions
- Type 2 Diabetes
- Being tested
- Tirzepatide, Dulaglutide, Semaglutide
- Keywords
- Tirzepatide, Dulaglutide, Type 2 diabetes, Cardiovascular disease, Myocardial infarction, Stroke, Mortality
- Medical subject headings
- Diabetes Mellitus, Type 2, Cardiovascular Diseases, Myocardial Infarction, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TirzepatideDrug
Tirzepatide
DulaglutideDrug
Dulaglutide
SemaglutideDrug
Semaglutide
| Study group | Role | What they receive |
|---|---|---|
| Tirzepatide | Patients who initiated tirzepatide with no use in the prior 180 days Receives: Drug: Tirzepatide | |
| Dulaglutide | Patients who initiate dulaglutide with no use in the prior 180 days Receives: Drug: Dulaglutide | |
| Semaglutide | Patients who initiate semaglutide with no use in the prior 180 days Receives: Drug: Semaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite CV outcome
Composite CV outcome includes myocardial infarction, stroke, and all-cause mortality.
Measured: From treatment initiation to end of follow up, up to 48 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start1 Nov 2024
- Primary completion1 Dec 2025
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 Brigham and Women's HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 70,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elisabetta Patorno, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06779929
- Sponsor's protocol ID
- 2024P001317
- Status last verified
- Sep 2026
- First submitted
- 10 Jan 2025
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Nicholls SJ, Bhatt DL, Buse JB, Prato SD, Kahn SE, Lincoff AM, McGuire DK, Nauck MA, Nissen SE, Sattar N, Zinman B, Zoungas S, Basile J, Bartee A, Miller D, Nishiyama H, Pavo I, Weerakkody G, Wiese RJ, D'Alessio D; SURPASS-CVOT investigators. Comparison of tirzepatide and dulaglutide on major adverse cardiovascular events in participants with type 2 diabetes and atherosclerotic cardiovascular disease: SURPASS-CVOT design and baseline characteristics. Am Heart J. 2024 Jan;267:1-11. doi: 10.1016/j.ahj.2023.09.007. Epub 2023 Sep 25.
PubMed 37758044Ostrominski JW, Ortega-Montiel J, Wexler DJ, Everett BM, Cromer SJ, Byrne CF, Glynn RJ, Paik JM, Patorno E. Comparative Effectiveness of Tirzepatide Versus Dulaglutide or Semaglutide on Major Cardiovascular Events in Type 2 Diabetes and Cardiovascular Disease: Insights From Two Target-Trial Emulations. Diabetes Care. 2026 May 1;49(5):808-817. doi: 10.2337/dc25-3063.
PubMed 41778928
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Tirzepatide vs Dulaglutide (SURPASS CVOT) or Semaglutide on Major Cardiovascular Events in Participants With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT06779929
- Acronym / sponsor ID
- 2024P001317
- Conditions
- Type 2 Diabetes
- Keywords
- Tirzepatide, Dulaglutide, Type 2 diabetes, Cardiovascular disease, Myocardial infarction, Stroke, Mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70,000 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 17 Jan 2025 (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 cohort study was initiated to emulate the design of the SURPASS-CVOT trial using observational analogues of the trial design components in a study based on insurance claims data.
Detailed description
Recent evidence suggests that the metabolic effects of glucagon-like peptide-1 receptor agonists (GLP-1RA) can be enhanced by combining them with the actions of other entero-pancreatic hormones, such as glucose-dependent insulinotropic polypeptide (GIP) and/or glucagon. Tirzepatide is a once-weekly GIP/GLP-1RA, approved for the treatment of type 2 diabetes in May 2022.
The Study of Tirzepatide Compared With Dulaglutide on Major Cardiovascular Events in Participants With Type 2 Diabetes (SURPASS-CVOT; NCT04255433) is an event-driven, randomized, double- blind, active comparator, parallel-group study, to evaluate cardiovascular (CV) outcomes with tirzepatide treatment in people with type 2 diabetes (T2D) and established atherosclerotic CV disease (ASCVD) compared with dulaglutide treatment, stratified by baseline sodium-glucose cotransporter-2 (SGLT2) inhibitors use. SURPASS-CVOT was designed to establish CV protection with tirzepatide by demonstrating noninferiority of tirzepatide to dulaglutide, and also to determine whether tirzepatide produces a greater CV benefit than dulaglutide (superiority analysis).
This new user active comparator cohort study aims to emulate the SURPASS-CVOT trial using insurance claims data. Trial design parameters were adapted in claims data using observational analogues for eligibility criteria, treatment strategies, treatment assignment, follow-up start, follow-up end, outcome, and causal contrast. We also conducted HbA1c-adjusted analyses among those with HbA1c values (54% of population).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tirzepatide | – | Drug: TirzepatidePatients who initiated tirzepatide with no use in the prior 180 days |
| Dulaglutide | – | Drug: DulaglutidePatients who initiate dulaglutide with no use in the prior 180 days |
| Semaglutide | – | Drug: SemaglutidePatients who initiate semaglutide with no use in the prior 180 days |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients > 40 years old with T2D and established atherosclerotic cardiovascular disease.
Key inclusion criteria (11 listed)
- Patients with T2D who were new users of tirzepatide or new users of dulaglutide
- AND established ASCVD defined as:
- Age >= 40 years old
- Patients with at least 180 days of continuous health plan enrollment before and including the treatment initiation date
Key exclusion criteria (19 listed)
- Patients with Type 1 diabetes mellitus
- Patients with missing age or sex information
- Patients with history of proliferative diabetic retinopathy, panretinal photocoagulation, vitreous hemorrhage, or intravitreal anti-VEGF injection
- Patient within history of left ventricular assisted device (LVAD) or heart transplant
- Patients with any previous organ transplants
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 |
|---|---|---|
| TirzepatideTirzepatide | Drug | Tirzepatide |
| DulaglutideDulaglutide | Drug | Dulaglutide |
| SemaglutideSemaglutide | Drug | Semaglutide |
Primary outcome
Composite CV outcome
Time frame: From treatment initiation to end of follow up, up to 48 months.
Composite CV outcome includes myocardial infarction, stroke, and all-cause mortality.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Background: PubMed 37758044Nicholls SJ, Bhatt DL, Buse JB, Prato SD, Kahn SE, Lincoff AM, McGuire DK, Nauck MA, Nissen SE, Sattar N, Zinman B, Zoungas S, Basile J, Bartee A, Miller D, Nishiyama H, Pavo I, Weerakkody G, Wiese RJ, D'Alessio D; SURPASS-CVOT investigators. Comparison of tirzepatide and dulaglutide on major adverse cardiovascular events in participants with type 2 diabetes and atherosclerotic cardiovascular disease: SURPASS-CVOT design and baseline characteristics. Am Heart J. 2024 Jan;267:1-11. doi: 10.1016/j.ahj.2023.09.007. Epub 2023 Sep 25.
- Results publication: PubMed 41778928Ostrominski JW, Ortega-Montiel J, Wexler DJ, Everett BM, Cromer SJ, Byrne CF, Glynn RJ, Paik JM, Patorno E. Comparative Effectiveness of Tirzepatide Versus Dulaglutide or Semaglutide on Major Cardiovascular Events in Type 2 Diabetes and Cardiovascular Disease: Insights From Two Target-Trial Emulations. Diabetes Care. 2026 May 1;49(5):808-817. doi: 10.2337/dc25-3063.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes, run by Brigham and Women's Hospital at 1 site in United States.
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 11 inclusion and 19 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: finished, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Composite CV outcome (time frame: From treatment initiation to end of follow up, up to 48 months.). 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 NCT06779929, which also lists 2 linked publications.
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 18 Sep 2026.