J2A-MC-GZGS: A Phase 3, Open-Label Study of Once Daily Orforglipron Compared with Insulin Glargine in Adult Participants with Type 2 Diabetes and Obesity or Overweight at Increased Cardiovascular Risk (ACHIEVE-4)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-502833-25-00

Acronym

J2A-MC-GZGS

Enrollment

1040

Registered

2023-08-01

Start date

2023-08-02

Completion date

Unknown

Last updated

2025-11-26

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

Conditions

Overweight, Obesity, Type 2 Diabetes, Cardiovascular Diseases, Overweight or Obesity, Chronic Kidney disease

Brief summary

Time to First Occurrence of Any Major Adverse Cardiovascular Event (MACE-4) [Myocardial Infarction (MI), Stroke, Hospitalization for Unstable Angina, or Cardiovascular (CV) death]

Interventions

DRUGORFORGLIPRON

DRUGCANAGLIFLOZIN

DRUGABASAGLAR 100 units/mL KwikPen solution for injection in a pre-filled pen

DRUGDAPAGLIFLOZIN

DRUG-

DRUGOrforglipron

DRUGEMPAGLIFLOZIN

DRUGERTUGLIFLOZIN

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Time to First Occurrence of Any Major Adverse Cardiovascular Event (MACE-4) [Myocardial Infarction (MI), Stroke, Hospitalization for Unstable Angina, or Cardiovascular (CV) death]	—

Countries

Austria, Czechia, Germany, Greece, Italy, Romania, Slovakia, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026