Recruiting
Phase 3

Orforglipron

Sponsor:

Eli Lilly and Company

Code:

NCT07241390

Conditions

Atherosclerosis Cardiovascular Disease

Chronic Kidney Disease

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

Orforglipron

Placebo

Study Details

Brief summary:

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.

Conditions

Atherosclerosis Cardiovascular Disease

Chronic Kidney Disease

Study ID

NCT07241390

Start date

Dec 1, 2025

Status verified date

Sep, 2026

Completion date

Aug, 2031

Anticipated

Primary completion date

Aug, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

7140 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Orforglipron

Participants will receive orforglipron orally + standard of care

placebo comparator: Placebo

Participants will receive placebo orally + standard of care

Interventions

Orforglipron

Administered orally

Placebo

Administered orally

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 and Locations

Central contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

317-615-4559LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

Locations

Centricity Research Brampton Endocrinology

Recruiting

Brampton, Canada, L6S 0C6

Contacts

905 595 0560

Principal Investigator:

Harpreet Bajaj

Cambridge Cardiac Care Centre

Recruiting

Cambridge, Canada, N1R 6V6

Contacts

5196243511

Principal Investigator:

A. Shekhar Pandey

Ecogene-21

Recruiting

Chicoutimi, Canada, G7H 7K9

Contacts

418-545-1252

Principal Investigator:

Daniel Gaudet

Premier Clinical Trial Network

Recruiting

Hamilton, Canada, L8L 5G4

Contacts

905 407 8945

Principal Investigator:

Richard Tytus

The Wharton Medical Clinic Clinical Trials Inc

Recruiting

Hamilton, Canada, L8L 5G8

Contacts

1-905-523-8134 Ext. 274

Principal Investigator:

Sean Wharton

THEO Medical Concorde

Recruiting

Laval, Canada, H7G 2E6

Contacts

438-320-7171

Principal Investigator:

Naim Ben Yedder

G A Research Associates

Recruiting

Moncton, Canada, E1G 1A7

Contacts

506-852-9865

Principal Investigator:

Jocelyn Cormier

Applied Medical Informatics Research

Recruiting

Montreal, Canada, H4A 3T2

Principal Investigator:

Michael Tsoukas

CHU de Quebec - Université Laval - Hotel Dieu de Quebec

Recruiting

Québec, Canada, G1R 2J6

Principal Investigator:

Mohsen Agharazii

Diex Recherche Inc. Division Quebec

Recruiting

Québec, Canada, G1V 4T3

Principal Investigator:

Marie-Philippe Morin

Bluewater Clinical Research Group Inc.

Recruiting

Sarnia, Canada, N7T 4X3

Contacts

1 (519) 344-6612

Principal Investigator:

John O'Mahony

Heart Health Institute - Scarborough Office

Recruiting

Scarborough, Canada, M1B 4Z8

Principal Investigator:

Andrew Yadegari

Kidney Care Centre - Surrey

Recruiting

Surrey, Canada, V3W 1J8

Principal Investigator:

Micheli Bevilacqua

C.I.C. Mauricie inc.

Recruiting

Trois-Rivières, Canada, G8T 7A1

Principal Investigator:

Pierre-Alexandre Menard

Diex Recherche Inc. Division Trois-Rivieres

Recruiting

Trois-Rivières, Canada, G9A 4P3

Contacts

819-801-9797

Principal Investigator:

Ying Sia

Clinical Research Solutions - Kitchener

Recruiting

Waterloo, Canada, N2T 0C1

Contacts

519 743 2573

Principal Investigator:

Shivinder Jolly

Winchester District Memorial Hospital

Recruiting

Winchester, Canada, K0C 2K0

Contacts

613-774-2420 ext 6211

Principal Investigator:

Rimon Ghattas

Glanz Medicine Professional Corporation

Recruiting

Windsor, Canada, N8X 5A6

Contacts

5192545726

Principal Investigator:

Anthony Glanz

Seven Oaks General Hospital

Recruiting

Winnipeg, Canada, R2V 3M3

Principal Investigator:

Navdeep Tangri

More Information

Sponsor

Eli Lilly and Company

Last update posted

Sep 8, 2026

Last verified

Sep, 2026

Keywords

  • Heart Disease
  • Kidney Disease
  • Outcomes
  • Stroke

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-09-08.