GZPW

• Research type

  Research Study

• Full title

  A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Event-Driven Study to Investigate the Effect of Orforglipron on the Incidence of Major Adverse Cardiovascular Events in Participants with Established Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease (ATTAIN-Outcomes)

• IRAS ID

  1012717

• Contact name

  Maryna Kvochka

• Contact email

  EU_lilly_clinical_trials@lilly.com

• Sponsor organisation

  Eli Lilly and Company

• Research summary

  The main purpose of this study is to determine if orforglipron can reduce the incidence of serious heart-related complications. Participants will be randomly assigned (1:1 ratio) to receive either orforglipron or placebo orally once daily added to their existing standard of care medications.
  This study includes:
  - Screening (Period I)
  - Dose-escalation treatment period – participants will have study visits every 4 weeks
  - Maintenance treatment period – participants will have study visits every 6 months
  The trial will enrol adults age 50 or above who have atherosclerotic cardiovascular disease and/or chronic kidney disease, and a body mass index of 25 kg/m2 or higher.
  Approximately 7140 participants will be enrolled globally. The study will last about 5 years.

• REC name

  London - Brighton & Sussex Research Ethics Committee

• REC reference

  25/LO/0717

• Date of REC Opinion

  22 Oct 2025

• REC opinion

  Further Information Favourable Opinion