Type 2 DiabetesTIRZSEMA-CVOTNCT07096063
Comparative Effectiveness of Tirzepatide and Semaglutide in Individuals at Cardiovascular Risk
An observational study of Type 2 Diabetes and Overweight, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
Investigators are building an empirical evidence base for real-world data through large-scale emulation of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes, Overweight, Cardiovascular (CV) Risk
- What is being tested?
- Tirzepatide, Dulaglutide and Semaglutide
- How many people
- 887,132 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2024to 15 Jul 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals typically treated in clinical practice who are at cardiovascular risk with type 2 diabetes mellitus and overweight.
Who may be able to join
- History of MI, stroke, any surgical or percutaneous revascularization procedure, use of any antihypertensive/lipid-lowering drugs, coronary/carotid/peripheral artery disease, hypertension
- Type 2 diabetes
- BMI ≥25.0kg/m2
- Age ≥18 years
- Male or female sex
- History of MI, stroke, any surgical or percutaneous revascularization procedure, use of any antihypertensive/lipid-lowering drugs, coronary/carotid/peripheral artery disease, hypertension
Show all 15Show fewer
- Type 2 diabetes
- BMI ≥25.0kg/m2
- Age ≥18 years
- Male or female sex
- History of MI, stroke, any surgical or percutaneous revascularization procedure, use of any antihypertensive/lipid-lowering drugs, coronary/carotid/peripheral artery disease, hypertension
- Type 2 diabetes
- BMI ≥25.0kg/m2
- Age ≥18 years
- Male or female sex
Who cannot join
- Medullary thyroid carcinoma, MEN syndrome type 2
- Malignancy
- Type 1 diabetes or secondary diabetes
- Chronic kidney disease or dialysis
- Uncontrolled diabetic retinopathy or maculopathy
- Pregnancy
Show all 23Show fewer
- Prior use of pramlintide or any GLP-1-RA
- ELIGIBILITY FOR SEMAGLUTIDE VS SITAGLIPTIN
- Medullary thyroid carcinoma, MEN syndrome type 2
- Malignancy
- Type 1 diabetes or secondary diabetes
- Chronic kidney disease or dialysis
- Uncontrolled diabetic retinopathy or maculopathy
- Pregnancy
- Prior use of pramlintide or any GLP-1-RA or DPP4i
- ELIGIBILITY FOR TIRZEPATIDE VS SEMAGLUTIDE
- Medullary thyroid carcinoma, MEN syndrome type 2
- Malignancy
- Type 1 diabetes or secondary diabetes
- Chronic kidney disease or dialysis
- Uncontrolled diabetic retinopathy or maculopathy
- Pregnancy
- Prior use of pramlintide or any GLP-1-RA
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02120
About this study
Investigators are building an empirical evidence base for real-world data through large-scale emulation of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.
Read the detailed description
This is a non-randomized, non-interventional study that is part of the Randomized Controlled Trials Duplicated Using Prospective Longitudinal Insurance Claims: Applying Techniques of Epidemiology (RCT-DUPLICATE) initiative (www.rctduplicate.org) of the Brigham and Women's Hospital, Harvard Medical School. It is intended to assess the comparative effectiveness of
- Tirzepatide vs dulaglutide,
- Semaglutide vs sitagliptin,
- Tirzepatide vs semaglutide on cardiovascular outcomes in individuals typically treated in clinical practice who are at cardiovascular risk with type 2 diabetes (T2DM) and overweight but might not meet the eligibility criteria of pivotal RCTs for each drug (SUSTAIN-6 and SURPASS-CVOT trials), used to support regulatory approval in patients at cardiovascular risk.Although many features of the target trials cannot be directly replicated in healthcare claims, key design features, including outcomes, exposures, and inclusion/exclusion criteria, were selected to proxy those features from the target trial. Randomization cannot be achieved in healthcare claims data but was proxied through a statistical balancing of measured covariates according to standard practice.
The three database studies will be new-user active-comparative studies, conducted using 3 national United States claims databases, where investigators compare the effect of semaglutide vs sitagliptin (used as an active comparator placebo proxy), tirzepatide vs dulaglutide, and tirzepatide vs semaglutide on the composite end point of all-cause mortality, myocardial infarction, or stroke. Clinical guidelines during the study period recommended both tirzepatide and semaglutide for the same indications of glucose lowering and weight reduction.
- Conditions
- Type 2 Diabetes, Overweight, Cardiovascular (CV) Risk
- Being tested
- Tirzepatide, Dulaglutide, Semaglutide, Sitagliptin
- Medical subject headings
- Diabetes Mellitus, Type 2, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TirzepatideDrug
New use of tirzepatide dispensing claim is used as the exposure.
DulaglutideDrug
New use of dulaglutide dispensing claim is used as the comparator.
SemaglutideDrug
New use of semaglutide dispensing claim is used as the exposure/comparator.
SitagliptinDrug
New use of sitagliptin dispensing claim is used as the comparator.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Tirzepatide vs dulaglutide Receives: Drug: Tirzepatide; Drug: Dulaglutide | |
| Cohort 2 | Semaglutide vs sitagliptin Receives: Drug: Semaglutide; Drug: Sitagliptin | |
| Cohort 3 | Tirzepatide vs semaglutide Receives: Drug: Tirzepatide; Drug: Semaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of all-cause mortality, myocardial infarction or stroke (Tirzepatide vs. dulaglutide)
To evaluate the comparative effect of tirzepatide vs dulaglutide on the composite of all-cause mortality, myocardial infarction, or death in patients typically treated in clinical practice who are at cardiovascular risk with type 2 diabetes and overweight.
Measured: 1 day after cohort entry date until the first of outcome or censoring, up to 365 days
Composite of all-cause mortality, myocardial infarction or stroke (Injectable semaglutide vs sitagliptin)
To evaluate the comparative effect of injectable semaglutide vs sitagliptin on the composite of all-cause mortality, myocardial infarction, or death in patients typically treated in clinical practice who are at cardiovascular risk with type 2 diabetes and overweight.
Measured: 1 day after cohort entry date until the first of outcome or censoring, up to 365 days
Composite of all-cause mortality, myocardial infarction or stroke (Tirzepatide vs injectable semaglutide)
To evaluate the comparative effect of tirzepatide vs semaglutide on the composite of all-cause mortality, myocardial infarction, or death in patients typically treated in clinical practice who are at cardiovascular risk with type 2 diabetes and overweight.
Measured: 1 day after cohort entry date until the first of outcome or censoring, up to 365 days
Secondary outcomes (15)
Individual components of the primary endpoint, i.e., all-cause mortality, myocardial infarction, or stroke (Tirzepatide vs dulaglutide)
To evaluate the comparative effect of tirzepatide vs dulaglutide on the individual components of the primary endpoint, i.e., all-cause mortality, myocardial infarction, or stroke in patients typically treated in clinical practice who are at cardiovascular risk with type 2 diabetes and overweight.
Measured: 1 day after cohort entry date until the first of outcome or censoring, up to 365 days
Composite of all-cause mortality, hospitalization for heart failure, or urgent heart failure visits requiring intravenous diuretics (Tirzepatide vs dulaglutide)
To evaluate the comparative effect of tirzepatide vs dulaglutide on all-cause mortality, hospitalization for heart failure, or urgent heart failure visits in patients typically treated in clinical practice who are at cardiovascular risk with type 2 diabetes and overweight.
Measured: 1 day after cohort entry date until the first of outcome or censoring, up to 365 days
Urinary tract infections (Tirzepatide vs dulaglutide)
To evaluate the comparative effect of tirzepatide vs dulaglutide on the safety outcome of urinary tract infections in patients typically treated in clinical practice who are at cardiovascular risk with type 2 diabetes and overweight.
Measured: 1 day after cohort entry date until the first of outcome or censoring, up to 365 days
Serious bacterial infections (Tirzepatide vs dulaglutide)
To evaluate the comparative effect of tirzepatide vs dulaglutide on the safety outcome of serious bacterial infections in patients typically treated in clinical practice who are at cardiovascular risk with type 2 diabetes and overweight.
Measured: 1 day after cohort entry date until the first of outcome or censoring, up to 365 days
Gastrointestinal adverse events (Tirzepatide vs dulaglutide)
To evaluate the comparative effect of tirzepatide vs dulaglutide on the safety outcome of gastrointestinal adverse events in patients typically treated in clinical practice who are at cardiovascular risk with type 2 diabetes and overweight.
Measured: 1 day after cohort entry date until the first of outcome or censoring, up to 365 days
Individual components of the primary endpoint, i.e., all-cause mortality, myocardial infarction, or stroke (Injectable semaglutide vs sitagliptin)
To evaluate the comparative effect of injectable semaglutide vs sitagliptin on the individual components of the primary endpoint, i.e., all-cause mortality, myocardial infarction, or stroke in patients typically treated in clinical practice who are at cardiovascular risk with type 2 diabetes and overweight.
Measured: 1 day after cohort entry date until the first of outcome or censoring, up to 365 days
Composite of all-cause mortality, hospitalization for heart failure, or urgent heart failure visits requiring intravenous diuretics (Injectable semaglutide vs sitagliptin)
To evaluate the comparative effect of injectable semaglutide vs sitagliptin on all-cause mortality, hospitalization for heart failure, or urgent heart failure visits in patients typically treated in clinical practice who are at cardiovascular risk with type 2 diabetes and overweight.
Measured: 1 day after cohort entry date until the first of outcome or censoring, up to 365 days
Urinary tract infections (Injectable semaglutide vs sitagliptin)
To evaluate the comparative effect of injectable semaglutide vs sitagliptin on the safety outcome of urinary tract infections in patients typically treated in clinical practice who are at cardiovascular risk with type 2 diabetes and overweight.
Measured: 1 day after cohort entry date until the first of outcome or censoring, up to 365 days
Serious bacterial infections (Injectable semaglutide vs sitagliptin)
To evaluate the comparative effect of injectable semaglutide vs sitagliptin on the safety outcome of serious bacterial infections in patients typically treated in clinical practice who are at cardiovascular risk with type 2 diabetes and overweight.
Measured: 1 day after cohort entry date until the first of outcome or censoring, up to 365 days
Gastrointestinal adverse events (Injectable semaglutide vs sitagliptin)
To evaluate the comparative effect of injectable semaglutide vs sitagliptin on the safety outcome of gastrointestinal adverse events in patients typically treated in clinical practice who are at cardiovascular risk with type 2 diabetes and overweight.
Measured: 1 day after cohort entry date until the first of outcome or censoring, up to 365 days
Individual components of the primary endpoint, i.e., all-cause mortality, myocardial infarction, or stroke (Tirzepatide vs injectable semaglutide)
To evaluate the comparative effect of tirzepatide vs injectable semaglutide on the individual components of the primary endpoint, i.e., all-cause mortality, myocardial infarction, or stroke in patients typically treated in clinical practice who are at cardiovascular risk with type 2 diabetes and overweight.
Measured: 1 day after cohort entry date until the first of outcome or censoring, up to 365 days
Composite of all-cause mortality, hospitalization for heart failure, or urgent heart failure visits requiring intravenous diuretics (Tirzepatide vs injectable semaglutide)
To evaluate the comparative effect of tirzepatide vs injectable semaglutide on all-cause mortality, hospitalization for heart failure, or urgent heart failure visits in patients typically treated in clinical practice who are at cardiovascular risk with type 2 diabetes and overweight.
Measured: 1 day after cohort entry date until the first of outcome or censoring, up to 365 days
Urinary tract infections (Tirzepatide vs injectable semaglutide)
To evaluate the comparative effect of tirzepatide vs injectable semaglutide on the safety outcome of urinary tract infections in patients typically treated in clinical practice who are at cardiovascular risk with type 2 diabetes and overweight.
Measured: 1 day after cohort entry date until the first of outcome or censoring, up to 365 days
Serious bacterial infections (Tirzepatide vs injectable semaglutide)
To evaluate the comparative effect of tirzepatide vs injectable semaglutide on the safety outcome of serious bacterial infections in patients typically treated in clinical practice who are at cardiovascular risk with type 2 diabetes and overweight.
Measured: 1 day after cohort entry date until the first of outcome or censoring, up to 365 days
Gastrointestinal adverse events (Tirzepatide vs injectable semaglutide)
To evaluate the comparative effect of tirzepatide vs injectable semaglutide on the safety outcome of gastrointestinal adverse events in patients typically treated in clinical practice who are at cardiovascular risk with type 2 diabetes and overweight.
Measured: 1 day after cohort entry date until the first of outcome or censoring, up to 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start1 Oct 2024
- Primary completion15 Jul 2025
- Study completion15 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 887,132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shirley Vichy Wang, Brigham and Women's Hospital
- Investigators
- Shirley Wang, PhD, ScM, Principal investigator, Brigham and Women's HospitalNils Krüger, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07096063
- Sponsor's protocol ID
- 2018P002966-DUP-TIRZSEMA-CVOT
- Acronym
- TIRZSEMA-CVOT
- Status last verified
- Aug 2025
- First submitted
- 23 Jul 2025
- Last updated
- 15 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Kruger N, Schneeweiss S, Desai RJ, Sreedhara SK, Kehoe AR, Fuse K, Hahn G, Schunkert H, Wang SV. Cardiovascular outcomes of semaglutide and tirzepatide for patients with type 2 diabetes in clinical practice. Nat Med. 2026 Jan;32(1):342-352. doi: 10.1038/s41591-025-04102-x. Epub 2025 Nov 9.
PubMed 41207920
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Tirzepatide and Semaglutide in Individuals at Cardiovascular Risk
- ClinicalTrials.gov ID
- NCT07096063
- Acronym / sponsor ID
- TIRZSEMA-CVOT / 2018P002966-DUP-TIRZSEMA-CVOT
- Conditions
- Type 2 Diabetes, Overweight, Cardiovascular (CV) Risk
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 887,132 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 15 Jul 2025 (actual)
- Study completion
- 15 Jul 2025 (actual)
- First posted
- 31 Jul 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.
Investigators are building an empirical evidence base for real-world data through large-scale emulation of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.
Detailed description
This is a non-randomized, non-interventional study that is part of the Randomized Controlled Trials Duplicated Using Prospective Longitudinal Insurance Claims: Applying Techniques of Epidemiology (RCT-DUPLICATE) initiative (www.rctduplicate.org) of the Brigham and Women's Hospital, Harvard Medical School. It is intended to assess the comparative effectiveness of
- Tirzepatide vs dulaglutide,
- Semaglutide vs sitagliptin,
- Tirzepatide vs semaglutide on cardiovascular outcomes in individuals typically treated in clinical practice who are at cardiovascular risk with type 2 diabetes (T2DM) and overweight but might not meet the eligibility criteria of pivotal RCTs for each drug (SUSTAIN-6 and SURPASS-CVOT trials), used to support regulatory approval in patients at cardiovascular risk.Although many features of the target trials cannot be directly replicated in healthcare claims, key design features, including outcomes, exposures, and inclusion/exclusion criteria, were selected to proxy those features from the target trial. Randomization cannot be achieved in healthcare claims data but was proxied through a statistical balancing of measured covariates according to standard practice.
The three database studies will be new-user active-comparative studies, conducted using 3 national United States claims databases, where investigators compare the effect of semaglutide vs sitagliptin (used as an active comparator placebo proxy), tirzepatide vs dulaglutide, and tirzepatide vs semaglutide on the composite end point of all-cause mortality, myocardial infarction, or stroke. Clinical guidelines during the study period recommended both tirzepatide and semaglutide for the same indications of glucose lowering and weight reduction.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Drug: Tirzepatide, Drug: DulaglutideTirzepatide vs dulaglutide |
| Cohort 2 | – | Drug: Semaglutide, Drug: SitagliptinSemaglutide vs sitagliptin |
| Cohort 3 | – | Drug: Tirzepatide, Drug: SemaglutideTirzepatide vs semaglutide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals typically treated in clinical practice who are at cardiovascular risk with type 2 diabetes mellitus and overweight.
Key inclusion criteria (15 listed)
- History of MI, stroke, any surgical or percutaneous revascularization procedure, use of any antihypertensive/lipid-lowering drugs, coronary/carotid/peripheral artery disease, hypertension
- Type 2 diabetes
- BMI ≥25.0kg/m2
- Age ≥18 years
- Male or female sex
Key exclusion criteria (23 listed)
- Medullary thyroid carcinoma, MEN syndrome type 2
- Malignancy
- Type 1 diabetes or secondary diabetes
- Chronic kidney disease or dialysis
- Uncontrolled diabetic retinopathy or maculopathy
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 |
|---|---|---|
| TirzepatideNew use of tirzepatide dispensing claim is used as the exposure. | Drug | Cohort 1, Cohort 3 |
| DulaglutideNew use of dulaglutide dispensing claim is used as the comparator. | Drug | Cohort 1 |
| SemaglutideNew use of semaglutide dispensing claim is used as the exposure/comparator. | Drug | Cohort 2, Cohort 3 |
| SitagliptinNew use of sitagliptin dispensing claim is used as the comparator. | Drug | Cohort 2 |
Primary outcome
Composite of all-cause mortality, myocardial infarction or stroke (Tirzepatide vs. dulaglutide)
Time frame: 1 day after cohort entry date until the first of outcome or censoring, up to 365 days
To evaluate the comparative effect of tirzepatide vs dulaglutide on the composite of all-cause mortality, myocardial infarction, or death in patients typically treated in clinical practice who are at cardiovascular risk with type 2 diabetes and overweight.
Composite of all-cause mortality, myocardial infarction or stroke (Injectable semaglutide vs sitagliptin)
Time frame: 1 day after cohort entry date until the first of outcome or censoring, up to 365 days
To evaluate the comparative effect of injectable semaglutide vs sitagliptin on the composite of all-cause mortality, myocardial infarction, or death in patients typically treated in clinical practice who are at cardiovascular risk with type 2 diabetes and overweight.
Composite of all-cause mortality, myocardial infarction or stroke (Tirzepatide vs injectable semaglutide)
Time frame: 1 day after cohort entry date until the first of outcome or censoring, up to 365 days
To evaluate the comparative effect of tirzepatide vs semaglutide on the composite of all-cause mortality, myocardial infarction, or death in patients typically treated in clinical practice who are at cardiovascular risk with type 2 diabetes and overweight.
15 secondary outcomes
Individual components of the primary endpoint, i.e., all-cause mortality, myocardial infarction, or stroke (Tirzepatide vs dulaglutide)
Time frame: 1 day after cohort entry date until the first of outcome or censoring, up to 365 days
Composite of all-cause mortality, hospitalization for heart failure, or urgent heart failure visits requiring intravenous diuretics (Tirzepatide vs dulaglutide)
Time frame: 1 day after cohort entry date until the first of outcome or censoring, up to 365 days
Urinary tract infections (Tirzepatide vs dulaglutide)
Time frame: 1 day after cohort entry date until the first of outcome or censoring, up to 365 days
Serious bacterial infections (Tirzepatide vs dulaglutide)
Time frame: 1 day after cohort entry date until the first of outcome or censoring, up to 365 days
Gastrointestinal adverse events (Tirzepatide vs dulaglutide)
Time frame: 1 day after cohort entry date until the first of outcome or censoring, up to 365 days
Individual components of the primary endpoint, i.e., all-cause mortality, myocardial infarction, or stroke (Injectable semaglutide vs sitagliptin)
Time frame: 1 day after cohort entry date until the first of outcome or censoring, up to 365 days
Composite of all-cause mortality, hospitalization for heart failure, or urgent heart failure visits requiring intravenous diuretics (Injectable semaglutide vs sitagliptin)
Time frame: 1 day after cohort entry date until the first of outcome or censoring, up to 365 days
Urinary tract infections (Injectable semaglutide vs sitagliptin)
Time frame: 1 day after cohort entry date until the first of outcome or censoring, up to 365 days
Serious bacterial infections (Injectable semaglutide vs sitagliptin)
Time frame: 1 day after cohort entry date until the first of outcome or censoring, up to 365 days
Gastrointestinal adverse events (Injectable semaglutide vs sitagliptin)
Time frame: 1 day after cohort entry date until the first of outcome or censoring, up to 365 days
Individual components of the primary endpoint, i.e., all-cause mortality, myocardial infarction, or stroke (Tirzepatide vs injectable semaglutide)
Time frame: 1 day after cohort entry date until the first of outcome or censoring, up to 365 days
Composite of all-cause mortality, hospitalization for heart failure, or urgent heart failure visits requiring intravenous diuretics (Tirzepatide vs injectable semaglutide)
Time frame: 1 day after cohort entry date until the first of outcome or censoring, up to 365 days
Urinary tract infections (Tirzepatide vs injectable semaglutide)
Time frame: 1 day after cohort entry date until the first of outcome or censoring, up to 365 days
Serious bacterial infections (Tirzepatide vs injectable semaglutide)
Time frame: 1 day after cohort entry date until the first of outcome or censoring, up to 365 days
Gastrointestinal adverse events (Tirzepatide vs injectable semaglutide)
Time frame: 1 day after cohort entry date until the first of outcome or censoring, up to 365 days
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 15 Oct 2025.
- Derived from this study: PubMed 41207920Kruger N, Schneeweiss S, Desai RJ, Sreedhara SK, Kehoe AR, Fuse K, Hahn G, Schunkert H, Wang SV. Cardiovascular outcomes of semaglutide and tirzepatide for patients with type 2 diabetes in clinical practice. Nat Med. 2026 Jan;32(1):342-352. doi: 10.1038/s41591-025-04102-x. Epub 2025 Nov 9.
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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.
Shirley Wang, PhD, ScM principal investigator
Brigham and Women's Hospital
Nils Krüger, MD principal investigator
Brigham and Women's Hospital
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 and Overweight, 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 15 inclusion and 23 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 15 Oct 2025. 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 of all-cause mortality, myocardial infarction or stroke (Tirzepatide vs. dulaglutide) (time frame: 1 day after cohort entry date until the first of outcome or censoring, up to 365 days). The study lists 3 primary outcomes in all. 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 NCT07096063, which also lists 1 linked publication.
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 15 Oct 2025.