A Study of Orforglipron (LY3502970) on Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease (ATTAIN-Outcomes)

Sponsor
Eli Lilly and Company
Study ID
NCT07241390
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Orforglipron — DRUG
    Administered orally
  • Placebo — DRUG
    Administered orally

Study Details

The purpose of this study is to measure cardiovascular outcomes with orforglipron compared with placebo in participants with atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD). Participation in the study will last about 5 years.

Key Dates

Start date
Dec 1, 2025
Status verified
Jun 2026
Primary completion
Aug 31, 2031
Completion
Aug 31, 2031

Study Design

Enrollment
7,140 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Orforglipron
    Participants will receive orforglipron orally + standard of care
  • Placebo Comparator: Placebo
    Participants will receive placebo orally + standard of care

Primary Outcome Measure

Time to First Occurrence of Composite Endpoint of Major Cardiovascular Events [ Time Frame: Baseline up to end of study (about 5 years) ]

Central Contacts

  • Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
    317-615-4559
    [email protected]
  • Physicians interested in becoming principal investigators please contact
    [email protected]

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