Health Trials

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

ConditionsAtherosclerosis Cardiovascular DiseaseChronic Kidney Disease
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age50+
SponsorEli Lilly and Company

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Have established ASCVD and/or CKD

Disqualifiers

Have type 1 diabetes

Have had a major heart condition within 60 days prior to screening

Have New York Heart Association Functional Classification Class IV heart failure

Trial design

Design model

Parallel

Treatments tested in this trial

  • Orforglipron

    Drug

    Administered orally

  • Placebo

    Drug

    Administered orally

Treatment groups

7,140 Participants
are divided into 2 treatment groups
Group A: OrforglipronExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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)

Secondary outcomes

1

Time to First Occurrence of Composite Endpoint of Major Cardiovascular and Kidney Events

Composite endpoint includes nonfatal myocardial infarction, nonfatal stroke, hospitalization or urgent visit due to heart failure, coronary revascularization, ≥40% sustained decline in estimated glomerular filtration rate (eGFR), end-stage kidney disease, or all-cause death

Time frame
Baseline up to end of study (about 5 years)
2

Change from Baseline in Total eGFR Slope

Time frame
Baseline up to end of study (about 5 years)
3

Time to Onset of Type 2 Diabetes

Time frame
Baseline up to end of study (about 5 years)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eli Lilly and Company

Lead sponsor

Source ClinicalTrials.gov
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