This study is looking at people who have obesity or are overweight. The treatment being tested is tirzepatide, which is also known by its code name LY3298176. Some people in the study will receive tirzepatide while others will receive placebo. The purpose of this study is to find out if tirzepatide can reduce serious health problems and death in adults with obesity.
Tirzepatide is given as an injection under the skin using a pre-filled pen once a week. The study will compare people taking tirzepatide to people taking placebo to see if there is a difference in major health events. These events include death from any cause, heart attack that is not fatal, stroke that is not fatal, procedures to restore blood flow to the heart, or problems related to heart failure. The study is looking at whether tirzepatide can help prevent these serious health problems in people who are overweight or have obesity and also have heart disease or risk factors for heart disease such as smoking, abnormal levels of fats in the blood, high blood pressure, or kidney disease.
People in the study will continue taking the treatment for a period of time while doctors monitor their health and track whether any of these major health events occur. The study will measure how long it takes until the first occurrence of any of these serious health problems happens in people taking tirzepatide compared to those taking placebo. The treatment period can last up to 324 weeks.
1Initial assignment to treatment group
Upon joining the study, you will be randomly assigned to one of two groups. This process is called randomization and ensures fair distribution of participants.
One group will receive tirzepatide, which is the medication being tested. The other group will receive a placebo, which is an inactive substance that looks identical to the actual medication but contains no active ingredient.
Neither you nor the study staff will know which treatment you are receiving. This is called a double-blind study design and helps ensure accurate results.
2Receiving your assigned treatment
You will receive either tirzepatide or placebo as a solution for injection in a pre-filled pen.
The medication will be administered once weekly. This means you will receive one injection every seven days.
The treatment will continue throughout your participation in the study, which is expected to last until approximately September 2027.
3Regular monitoring visits
Throughout the study, you will attend scheduled visits where your health status will be monitored.
These visits are designed to track any changes in your condition and to observe for specific health events.
The study will monitor for events such as death from any cause, myocardial infarction (heart attack), stroke (interruption of blood flow to the brain), coronary revascularization (procedures to restore blood flow to the heart), and heart failure events (when the heart cannot pump blood effectively).
4Ongoing treatment period
You will continue receiving your assigned weekly injections throughout the study duration.
The study is designed to evaluate whether tirzepatide can reduce the occurrence of serious health events in adults with obesity or who are overweight.
Your participation is expected to continue until the study reaches its planned end date in September 2027, unless there are specific reasons to discontinue earlier.
5Study completion
The study will conclude when all participants have completed the planned treatment period and follow-up assessments.
Final evaluations will be conducted to assess the overall impact of the treatment on reducing health complications and mortality in participants with obesity.
Who Can Join the Study?
You must be overweight, which means having a body weight higher than what is considered healthy for your height, or have obesity, which means having a significantly higher amount of body fat than is healthy
You must be over 40 years of age and have cardiovascular disease, which means a condition affecting your heart and blood vessels, for at least 3 months before the study begins
If you are a woman, you must be at least 55 years of age without established heart disease but have cardiovascular risk factors, which are conditions that increase your chance of developing heart problems, such as smoking tobacco, having abnormal levels of fats called lipids in your blood, having high blood pressure which means the force of blood against your artery walls is too high, or having kidney disease which means your kidneys are not working properly
If you are a man, you must be at least 50 years of age without established heart disease but have cardiovascular risk factors, which are conditions that increase your chance of developing heart problems, such as smoking tobacco, having abnormal levels of fats called lipids in your blood, having high blood pressure which means the force of blood against your artery walls is too high, or having kidney disease which means your kidneys are not working properly
Who Cannot Join the Study?
The source data does not contain specific exclusion criteria, which are the reasons why a patient cannot participate in the study
Without detailed exclusion criteria information, it is not possible to list the specific conditions or situations that would prevent someone from joining this clinical trial
Typically, exclusion criteria may include things like certain other medical conditions, use of specific medications, pregnancy status, or recent participation in other studies, but these specific details are not provided in the available information
Tirzepatide is a medication being tested in this clinical trial to see if it can reduce health problems and death in adults with obesity. It is given as an injection once a week and works by helping the body control blood sugar levels and reduce appetite, which can lead to weight loss.
A placebo is also used in this study. A placebo looks like the real medication but contains no active medicine. It is used to compare the effects of tirzepatide against no treatment, helping researchers understand if tirzepatide truly works.
Obesity – Obesity is a medical condition characterized by excessive accumulation of body fat that may impair health. It occurs when a person consumes more calories than their body uses over an extended period. The excess energy is stored as fat tissue throughout the body. Obesity develops gradually as fat deposits increase in various body areas. This condition can affect multiple body systems and organs. The progression of obesity is typically measured using body mass index and body fat distribution.
Overweight – Overweight refers to a condition where a person has more body weight than is considered healthy for their height. It represents an intermediate stage between normal weight and obesity. The condition develops when caloric intake consistently exceeds energy expenditure. Body weight gradually increases as excess calories are converted to fat and stored in the body. Overweight can progress to obesity if the imbalance between calorie consumption and expenditure continues. The condition is commonly assessed through body mass index measurements.
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