J2A-MC-GZPW: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Event-Driven Study to Investigate the Effect of Orforglipron on the Incidence of Major Adverse Cardiovascular Events in Participants With Established Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-523123-22-00

Enrollment

548

Registered

2026-02-24

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease, Atherosclerosis Cardiovascular Disease

Brief summary

Time to First Occurrence of Composite Endpoint of Major Cardiovascular Events Composite endpoint includes nonfatal myocardial infarction, nonfatal stroke, hospitalization or urgent visit due to heart failure, coronary revascularization, or all-cause death [Time Frame: Baseline up to end of study (about 5 years)]

Interventions

DRUGPlacebo to match

DRUGOrforglipron

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Time to First Occurrence of Composite Endpoint of Major Cardiovascular Events Composite endpoint includes nonfatal myocardial infarction, nonfatal stroke, hospitalization or urgent visit due to heart failure, coronary revascularization, or all-cause death [Time Frame: Baseline up to end of study (about 5 years)]	—

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 25, 2026