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

Lilly

Status and phase: Begins enrollment in 1 month; Phase 3

Conditions: Chronic Kidney Disease; Atherosclerosis Cardiovascular Disease

Treatments: Drug: Orforglipron; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07241390

27771

2025-523123-22-00 (EU Trial (CTIS) Number)

J2A-MC-GZPW (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 7,140 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have established ASCVD and/or CKD

Exclusion criteria

• 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

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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7,140 participants in 2 patient groups, including a placebo group

Orforglipron

Experimental group

Description:

Participants will receive orforglipron orally + standard of care

Treatment:

Drug: Orforglipron

Placebo

Placebo Comparator group

Description:

Participants will receive placebo orally + standard of care

Treatment:

Drug: Placebo