Active not recruitingPHASE3INTERVENTIONAL

A Study of Tirzepatide (LY3298176) on the Reduction on Morbidity and Mortality in Adults With Obesity

This research study is investigating a new medication, Tirzepatide, for adults who are living with obesity. The main goal is to find out if this medicine can lower the risk of developing serious health complications that are often linked to obesity, such as heart disease. Researchers also want to see if it can help people live longer and healthier lives. This study will add to our understanding of how Tirzepatide might benefit a wide range of adults with obesity by potentially reducing their chances of experiencing severe health issues. Participants will either receive the study medication or a dummy treatment (placebo) to compare the effects.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Eli Lilly and Company

Enrolment target

15,374

Start

11 Oct 2022

Estimated completion

01 Oct 2027

Obesity Overweight

What is this study about?

This research study is looking into a medication named Tirzepatide, and how it might help adults who are living with obesity. Obesity can lead to several health problems over time, like heart disease or stroke, and this study aims to see if Tirzepatide can reduce the chances of these serious issues occurring. Essentially, the researchers want to find out if this medicine can help people with obesity live longer and healthier lives by preventing or delaying the onset of these complications.

For many years, doctors have been looking for effective ways to help people manage their weight and reduce the associated health risks. Tirzepatide is a new type of drug that is being studied for its potential benefits in this area. By comparing its effects to a 'dummy' treatment (called a placebo), the study hopes to clearly show whether Tirzepatide is effective and safe for this group of people.

The findings from this study will be very important for medical professionals and patients alike. If Tirzepatide proves to be successful, it could become another option in the fight against obesity and its potential health consequences, helping more people to manage their weight and improve their overall health.

Key takeaways

This study is testing a new medication, Tirzepatide, for adults with obesity.
It aims to see if Tirzepatide can reduce health problems and improve life expectancy.
Participants will receive either the study drug or a placebo.
Eligibility depends on your age, body mass index (BMI), and specific health conditions or risk factors.
Regular clinic visits and health checks will be part of taking part.
You can stop participating at any time.

Who may be eligible?

To join this study, you would generally need to be an adult over 40 years old and have a body mass index (BMI) of 27 or higher, which means you are considered overweight or living with obesity.

Specifically, the study is looking for two main groups of people. One group includes individuals aged 40 or older who already have certain heart and blood vessel conditions, such as coronary artery disease or a history of a 'mini-stroke'. The other group includes people who don't have these established heart conditions but do have several risk factors for them, such as being aged 50-69 for men or 55-69 for women with at least three risk factors like smoking, high cholesterol, or high blood pressure, or older individuals with at least two risk factors.

However, there are also some reasons why you might not be able to join. For example, if you have type 1 or type 2 diabetes, a history of certain serious heart events in the last three months (like a heart attack or stroke), or certain stomach problems, you likely wouldn't be able to participate. Also, if you have a history of specific thyroid cancers or severe liver problems, or have had or are planning weight-loss surgery, you would not be eligible.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 40 years old or older?
Is your Body Mass Index (BMI) 27 or higher?
Do you have existing heart disease or several risk factors for it (like high blood pressure or cholesterol)?
Do you NOT have type 1 or type 2 diabetes?
Have you NOT had a heart attack or stroke in the past 3 months?
Have you NOT had or are planning to have weight-loss surgery?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would typically have regular appointments at a clinic. At these visits, doctors and nurses will carry out various checks, such as measuring your weight, blood pressure, and taking blood samples. You would also receive either the study medication, Tirzepatide, or a placebo (a dummy treatment that looks like the medication but has no active ingredients). This is usually given as an injection. The study involves a period of taking the medication and having regular check-ups, followed by a follow-up period to see how you are doing after the treatment course. The total length of your involvement in the study would be agreed upon with the study team.

Potential risks and benefits

Participating in this study might offer potential benefits, such as receiving a medication that could help manage your weight and improve your health, though there’s no guarantee as you might receive the placebo. You’ll also get regular health checks and medical attention. However, like all medications, Tirzepatide may have side effects, and some tests or procedures involved in the study could carry minor risks. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (671)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Prime Medical Group, LLC dba Gilbert Center for Family Medicine, LLC
Verified postcode
Gilbert, United States
Aventiv Research
Verified postcode
Mesa, United States
Elite Clinical Studies
Verified postcode
Phoenix, United States
Pima Heart
Verified postcode
Tucson, United States
KLR Business Group, Inc. dba Arkansas Clinical Research
Verified postcode
Little Rock, United States
Smart Cures Clinical Research
Verified postcode
Anaheim, United States
Kidney & Hypertension Center - Apple Valley
Verified postcode
Apple Valley, United States
Hope Clinical Research, Inc.
Verified postcode
Canoga Park, United States
John Muir Physician Network Research Center
Verified postcode
Concord, United States
Neighborhood Healthcare Institute of Health
Verified postcode
Escondido, United States
HB Clinical Trials - Fountain Valley
Verified postcode
Fountain Valley, United States
Valiance Clinical Research
Verified postcode
Huntington Park, United States

Common questions

What is obesity?

Obesity is a medical condition where you have excess body fat that can negatively affect your health. It is often measured using something called Body Mass Index (BMI).

What is Tirzepatide?

Tirzepatide is a medication being studied for its potential to help with weight management and to improve health in people living with obesity.

What is a placebo?

A placebo is a 'dummy' treatment that looks exactly like the study medication but does not contain any active ingredients. It's used to fairly compare the effects of the actual medicine.

Will I know if I'm getting the real medication?

No, during the study, neither you nor your study doctor will know whether you are receiving the real medication or the placebo. This helps to keep the study results fair and unbiased.

How long does the study last?

The total length of time you would be involved in the study depends on the specific design, but it typically involves a period of treatment followed by a follow-up period.