LivingGLP1
Study S001090

A Phase 3, Open-Label Study of Once Daily LY3502970 Compared With Insulin Glargine in Adult Participants With Type 2 Diabetes and Obesity or Overweight at Increased Cardiovascular Risk

Registration

Registration
NCT05803421
Acronym
ACHIEVE-4
Study type
INTERVENTIONAL
Allocation
RANDOMIZED
Phase
PHASE3
Masking
NONE
Status
COMPLETED
Enrollment
2749
Start
2023-04-03
Primary completion
2026-03-16
Lead sponsor
Eli Lilly and Company
Conditions
Type 2 Diabetes; Obesity; Overweight or Obesity; Overweight; Cardiovascular Diseases; Chronic Kidney Disease
Interventions
DRUG:Orforglipron; DRUG:Insulin Glargine
Results posted
FALSE
Individual participant data sharing
YES
Secondary identifiers
OTHER:J2A-MC-GZGS; OTHER:2022-502833-25-00; OTHER:U1111-1285-6821

Registered primary outcomes

  • Time to First Occurrence of Any Major Adverse Cardiovascular Event (MACE-4) [Myocardial Infarction (MI), Stroke, Hospitalization for Unstable Angina, or Cardiovascular (CV) Death] [Baseline to End of the Study (Approximate Maximum 104 Weeks)]

Linked records (1)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.
RecordTitleYearDesignIdentifiersLink basis
R0005491Cardiovascular safety of orforglipron versus insulin glargine in adults with type 2 diabetes at increased cardiovascular risk (ACHIEVE-4): a phase 3, event-driven, randomised, open-label, non-inferiority, active comparator trial.
Klein KR, Lancet (London, England)
2026Randomized trialPMID 42815506DOIcites ClinicalTrials.gov:NCT05803421; registry reference DERIVED:42815506