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A study to evaluate the effect of orforglipron on cardiovascular health in adults with atherosclerotic cardiovascular disease and/or chronic kidney disease

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study aims to investigate whether orforglipron can reduce the risk of serious health problems related to the heart and blood vessels. The research focuses on individuals living with Atherosclerotic Cardiovascular Disease, a condition where plaque builds up in the arteries, and or Chronic Kidney Disease, which is a long-term condition where the kidneys do not work as well as they should. Participants will be given either orforglipron, which is an oral tablet, or a placebo.

During the study, participants will be monitored over a period of time to see how the medication affects the occurrence of major health events. These events include myocardial infarction, commonly known as a heart attack, stroke, or being hospitalized due to heart failure. The study also looks at coronary revascularization, which is a procedure used to improve blood flow to the heart, and any deaths caused by any reason.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Participation in the study

    You will be assigned to receive either the test medication, which is orforglipron, or a placebo. a placebo is a substance that looks and tastes like the real medicine but contains no active ingredients.

    The orforglipron is an oral tablet taken by mouth.

  2. Step 2

    Monitoring for cardiovascular events

    The study will monitor for the occurrence of major cardiovascular events. these include nonfatal myocardial infarction (a heart attack that does not result in death), nonfatal stroke, hospitalization or urgent visits due to heart failure, coronary revascularization (procedures to improve blood flow to the heart), and all-cause death.

    This monitoring phase continues from the baseline (the start of the study) until the end of the study, which is expected to be approximately 5 years.

Who can join the trial?

7 criteria

  • You must have heart disease, which means a problem with the heart or blood vessels.
  • You must have kidney disease, which means your kidneys are not working as well as they should.
  • You may have both heart disease and kidney disease.
  • You must have atherosclerosis cardiovascular disease, which is a condition where the arteries (the tubes that carry blood through your body) become hardened and narrow due to a buildup of fats and cholesterol.
  • You must be part of the patient group.
  • You must be within the specified age range, which corresponds to being between 3 and 17 years old based on the provided codes.
  • The study includes both females and males.

Who cannot join the trial?

3 criteria

  • You cannot participate if you have type 1 diabetes, which is a condition where the body does not produce the insulin needed to manage blood sugar levels.
  • You cannot participate if you have experienced a serious heart condition within 60 days before the study starts.
  • You cannot participate if you have NYHA Class IV heart failure, which is the most severe stage of heart failure where symptoms of heart failure occur even while at rest.
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Investigated drugs

Orforglipron is an oral medication being studied to see if it can help reduce the risk of major heart-related problems in people who already have heart disease or kidney disease.

What is already known about the treatment

  • Orforglipron

    This medication is taken as a tablet by mouth and is currently being studied in advanced clinical trials for its potential use in treating obesity and related metabolic issues. It belongs to a class of drugs known as GLP-1 receptor agonists, which work by mimicking a natural hormone in the body to help regulate blood sugar and reduce appetite. By activating specific receptors in the digestive system and brain, it helps control hunger and improve how the body handles energy. This study specifically investigates its ability to reduce the risk of major heart-related problems in people with existing heart or kidney conditions.

  • Placebo

    A placebo is an inactive substance, often in tablet form, that is administered orally to serve as a comparison in clinical research. It contains no active medicinal ingredients and is used to help researchers determine if the test drug truly produces a biological effect. In this study, it is used to provide a baseline to compare the effectiveness and safety of Orforglipron.

Investigated diseases

  • Chronic Kidney Disease

    This condition occurs when the kidneys gradually lose their ability to filter waste products from the blood. As the disease progresses, the kidneys become less efficient at maintaining the body's fluid and chemical balance. This decline can lead to an accumulation of harmful substances in the body. The damage often develops slowly over many years.

  • Atherosclerosis Cardiovascular Disease

    This condition involves the buildup of fats, cholesterol, and other substances in and on the artery walls. These deposits, known as plaques, cause the arteries to narrow and harden over time. As the arteries become more restricted, blood flow to vital organs and tissues is reduced. This process can eventually lead to serious complications involving the heart or brain.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-523123-22-00Protocol codeJ2A-MC-GZPWEstimated enrolment7 140 patientsSponsorEli Lilly & Co.

sourced from the EU Clinical Trials Register and site verification

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