Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Evaluation of Tirzepatide Versus Dulaglutide on Major Adverse Cardiovascular Events in Type 2 Diabetes Patients with High Cardiovascular Risk

Verified siteFast replyRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

This clinical trial is focused on studying the effects of a medication called tirzepatide on people with Type 2 Diabetes Mellitus. The study compares tirzepatide, which is given as a solution for injection, with another medication called dulaglutide. Both medications are designed to help manage blood sugar levels in people with Type 2 Diabetes, a condition where the body does not use insulin properly, leading to high blood sugar levels.

The purpose of the study is to see how well tirzepatide works compared to dulaglutide in reducing major cardiovascular events, such as heart attacks or strokes, in people with Type 2 Diabetes who are at high risk for heart problems. Participants in the study will receive either tirzepatide or dulaglutide, along with their usual diabetes care, to see which treatment is more effective in preventing these serious heart-related events.

The study will take place over a period of time, during which participants will receive regular injections of either tirzepatide or dulaglutide. The researchers will monitor the participants' health to track any occurrences of heart-related events. The goal is to determine if tirzepatide is not only as effective as dulaglutide but also if it might be superior in preventing major cardiovascular events in people with Type 2 Diabetes.

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

    Medication administration

    You will receive either tirzepatide or dulaglutide as an injection once every week (qw).

    If tirzepatide is assigned, the dose may increase over time, starting from 2.5 mg and potentially reaching up to 15 mg per week, depending on how the body tolerates the medication.

    If dulaglutide is assigned, the dose will be 1.5 mg once every week.

    These medications are provided in addition to your standard of care, which refers to the regular medical treatments you already receive for type 2 diabetes.

  2. Step 2

    Monitoring for cardiovascular events

    During the study, the focus is on monitoring for major adverse cardiovascular events (MACE-3).

    MACE-3 is a term used to group three specific health events: death caused by cardiovascular (heart and blood vessel) issues, myocardial infarction (a heart attack), or stroke.

Who can join the trial?

4 criteria

  • You must have a diagnosis of type 2 diabetes, which is a condition where your body has trouble managing blood sugar levels.
  • You must have confirmed atherosclerotic cardiovascular disease, which means there is a buildup of fats and cholesterol in your artery walls that can restrict blood flow.
  • Your HbA1c, which is a blood test that shows your average blood sugar levels over the past few months, must be between 7.0% and 10.5%.
  • Your Body Mass Index (BMI), a measurement used to determine if your weight is healthy for your height, must be 25 or higher.

Who cannot join the trial?

12 criteria

  • You have had a major cardiovascular event, which means a serious heart problem like a heart attack or stroke, within the last 60 days.
  • You or a family member have a history of medullary thyroid carcinoma (a specific type of thyroid cancer) or multiple endocrine neoplasia syndrome type 2 (a genetic condition that causes tumors in various glands).
  • You have had a blood transfusion (receiving blood through a vein) or lost a large amount of blood in the 90 days before starting the study.
  • You have hematological conditions, which are disorders related to the blood, that could make it difficult to measure your HbA1c (a blood test that shows your average blood sugar levels over the past few months).
  • You have type 1 diabetes, which is a condition where the body does not produce insulin.
  • You have experienced severe hypoglycemia (dangerously low blood sugar) or hypoglycemia unawareness (not being able to feel the warning signs of low blood sugar) in the last 6 months.
  • You are currently planning treatment for diabetic retinopathy (damage to the blood vessels in the retina at the back of the eye) or macular edema (swelling in the part of the eye responsible for sharp vision).
  • You are planning a revascularization procedure, which is a surgery to restore blood flow to the heart, neck (carotid artery), or limbs (peripheral arteries).
  • You have a history of pancreatitis, which is inflammation of the pancreas.
  • You have a history of ketoacidosis (a dangerous buildup of acids in the blood) or a hyperosmolar state/coma (a condition where blood sugar is extremely high, causing severe dehydration and loss of consciousness).
  • You have a known problem with gastric emptying (how fast food leaves your stomach), or you have had or are planning surgery for a gastric outlet obstruction (a blockage at the exit of the stomach), gastric bypass surgery, or other weight-loss surgeries that restrict the stomach.
  • You have a history of an active or untreated malignancy (cancer), or you have been in remission (a period where cancer signs and symptoms have decreased or disappeared) from a significant cancer for less than 5 years.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Tirzepatide

    is the experimental medication being tested in this study. It is an injection used to help manage blood sugar levels in people with type 2 diabetes and is being evaluated to see how well it protects against major heart-related problems like heart attack, stroke, or death from heart causes.

  • Dulaglutide

    is the comparison medication used in this study. It is an injection that also helps manage blood sugar levels in patients with type 2 diabetes, and it serves as the standard against which the effectiveness of the new treatment is measured.

What is already known about the treatment

  • Dulaglutide

    This medication is administered as a solution through a weekly injection under the skin. It is currently used in medicine to help manage type 2 diabetes by mimicking a natural hormone that stimulates insulin production. At a molecular level, it works by activating specific receptors in the body to improve blood sugar control and slow down digestion. It belongs to a group of drugs known as glucagon-like peptide-1 receptor agonists.

  • Tirzepatide

    This medication is given as a solution via a weekly injection under the skin. It is an established treatment used primarily for managing type 2 diabetes and weight control. It works at the molecular level by acting on two different hormone receptors in the body to help regulate blood sugar and appetite. This drug is classified as a dual glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist.

Investigated diseases

Type 2 Diabetes Mellitus - This is a chronic condition that affects how the body processes blood sugar. It occurs when the body either resists the effects of insulin or does not produce enough of it to maintain normal glucose levels. Over time, high levels of sugar in the blood can cause damage to various parts of the body. The condition often progresses gradually, starting with insulin resistance. As the disease advances, the pancreas may lose its ability to produce sufficient insulin.
Trial detailsLast updated 11 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-507846-96-00Protocol codeI8F-MC-GPGNEstimated enrolment13 299 patientsSponsorEli Lilly & Co.

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.