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NCT07203677 · ClinicalTrials.gov registry record

Comparative Effectiveness of Tirzepatide Versus Sitagliptin in Individuals at Cardiovascular Risk (TIRZSITA-CVOT)

A clinical trial of Type 2 Diabetes Mellitus and Atherosclerotic Cardiovascular Disease, sponsored by Brigham and Women's Hospital.

Completed
Registry status
49,065
Enrollment target
1
Study location

NCT07203677: Completed study of Type 2 Diabetes Mellitus and Atherosclerotic Cardiovascular Disease, sponsored by Brigham and Women's Hospital.

NCT07203677 is a study of Type 2 Diabetes Mellitus and Atherosclerotic Cardiovascular Disease that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 49,065 participants, above the 2,582-participant average among 130 other Type 2 Diabetes Mellitus trials with a reported enrollment target (1800% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07203677, a study of Type 2 Diabetes Mellitus and Atherosclerotic Cardiovascular Disease, has completed, sponsored by Brigham and Women's Hospital.

COMPLETED
Registry status
49,065 participants
Enrollment target
1
Study location

Study 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.

Primary Outcome

To evaluate the comparative effect of tirzepatide vs sitagliptin on the composite of myocardial infarction, stroke, or all-cause mortality in patients with type 2 diabetes and atherosclerotic cardiovascular disease when following the inclusion and exclusion criteria of the SURPASS-CVOT trial.

Interventions

  • DRUG Initiation of tirzepatide
  • DRUG Initiation of sitagliptin

Study Locations (1)

Massachusetts

  • Brigham and Women's Hospital - Boston

Trial Details

FieldValue
Enrollment Target 49,065 participants
Start Date 2025-09-19
Est. Completion 2025-10-15
Brigham and Women's Hospital

937 total trials

What the finished NCT07203677 record still lists

NCT07203677 is an observational study that tracks outcomes without assigning an intervention. Its 49,065 participants enrollment target places it among the larger protocols in the corpus, above the 2,582-participant average among 130 other Type 2 Diabetes Mellitus trials with a reported enrollment target (1800% higher).

The record links to 2 conditions, with Type 2 Diabetes Mellitus appearing as the primary indexed condition, and to 2 interventions - of which Initiation of tirzepatide is the first listed.

NCT07203677 reports a single indexed study location in Massachusetts.

Frequently Asked Questions

What is clinical trial NCT07203677 about?

NCT07203677 is a clinical study titled "Comparative Effectiveness of Tirzepatide Versus Sitagliptin in Individuals at Cardiovascular Risk (TIRZSITA-CVOT)". 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 s...

What is the current status of trial NCT07203677?

This trial is currently completed. The enrollment target is 49,065 participants. The study started on 2025-09-19. Estimated completion is 2025-10-15.

What conditions does trial NCT07203677 study?

This clinical trial studies the following conditions: Type 2 Diabetes Mellitus, Atherosclerotic Cardiovascular Disease.

What interventions are being tested in trial NCT07203677?

The interventions under investigation include: Initiation of tirzepatide (DRUG), Initiation of sitagliptin (DRUG).

Who is sponsoring clinical trial NCT07203677?

This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07203677 being conducted?

This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Type 2 Diabetes Mellitus

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT07203677's enrollment target sits among peer trials

49,065 4th of 130 higher than 127 of 130 other Type 2 Diabetes Mellitus trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Type 2 Diabetes Mellitus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT07203677, the US trial registry maintained by the National Library of Medicine. NCT07203677 (large enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.