NCT06980623

Brief Summary

This cohort study aims to assess the comparative effectiveness of tirzepatide versus semaglutide with respect to cardiovascular events in patients with type 2 diabetes and heart failure with preserved ejection fraction.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
26,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 20, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

December 12, 2025

Status Verified

December 1, 2025

Enrollment Period

11 months

First QC Date

May 12, 2025

Last Update Submit

December 5, 2025

Conditions

Type 2 DiabetesHeart Failure

Keywords

TirzepatideSemaglutideType 2 diabetesHeart failureCardiovascular diseaseMortality

Outcome Measures

Primary Outcomes (1)

  • Hospitalization for heart failure and all-cause mortality

    Cardiovascular outcome includes hospitalization for HF and all-cause mortality

    From treatment initiation to end of follow up, up to 48 months.

Study Arms (2)

Tirzepatide

Patients who initiated tirzepatide with no use in the prior 180 days

Drug: Tirzepatide

Semaglutide

Patients who initiate semaglutide with no use in the prior 180 days

Drug: Semaglutide

Interventions

TirzepatideDRUG

Exposure group

Tirzepatide
SemaglutideDRUG

Referent group

Semaglutide

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients \> 18 years old with T2D and HFpEF.

You may qualify if:

  • Patients who are new users of tirzepatide or new users of semaglutide
  • Patients with diagnosis of T2D and HFpEF, i.e., EF \>= 45%.
  • Age \>= 18 years old
  • Patients with continuous health plan enrollment before and including the treatment initiation date

You may not qualify if:

  • Patients with missing age or sex information
  • Patients with type 1 diabetes mellitus, secondary or gestational diabetes
  • History of diabetes related complications
  • Patients with related chronic diseases.
  • History of gastrointestinal conditions.
  • Previous exposure to other GLP-1RA and pramlintide
  • Patients with prescription dispensing for both tirzepatide and semaglutide on cohort entry date

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02120, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Heart FailureCardiovascular Diseases

Interventions

Tirzepatidesemaglutide

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHeart Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide-1 ReceptorGlucagon-Like Peptide ReceptorsReceptors, G-Protein-CoupledReceptors, Cell SurfaceMembrane ProteinsProteinsAmino Acids, Peptides, and ProteinsReceptors, Gastrointestinal HormoneReceptors, Peptide

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, DrPH

Study Record Dates

First Submitted

May 12, 2025

First Posted

May 20, 2025

Study Start

January 1, 2025

Primary Completion

November 30, 2025

Study Completion

March 1, 2026

Last Updated

December 12, 2025

Record last verified: 2025-12

Locations

US(1)