Study of Retatrutide for Patients with Type 2 Diabetes and Obesity or Overweight
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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 treatment called Retatrutide in people who have Type 2 Diabetes and are either Obese or Overweight. The treatment involves a solution for injection that is administered under the skin. The study aims to evaluate how effective and safe Retatrutide is for individuals with these conditions.
Participants in the study will receive either the Retatrutide injection or a placebo injection. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo. This helps ensure that the results are unbiased. The main goal is to observe any changes in body weight from the start of the study.
The study will take place over a period of time, with participants receiving weekly injections. Throughout the study, participants will be monitored to assess the treatment's impact on their weight and overall health. The study is part of a larger research effort to find effective treatments for managing Type 2 Diabetes in individuals who are also dealing with obesity or being overweight.
The research process
The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
5 criteria
- Must be overweight or have obesity.
- Must have Type 2 Diabetes.
- Must be on a stable treatment for Type 2 Diabetes for at least 90 days before starting the study.
- Must have a history of unsuccessful weight loss.
- Both male and female participants are eligible.
Who cannot join the trial?
8 criteria
- Having a medical condition other than Type 2 Diabetes, Obesity, or Overweight that might interfere with the study.
- Being under the age of 18 or over the age of 75.
- Being pregnant or planning to become pregnant during the study.
- Having a history of severe allergic reactions to any medication.
- Currently participating in another clinical trial.
- Having a medical condition that requires regular use of certain medications that might interfere with the study.
- Having a history of drug or alcohol abuse within the past year.
- Having a significant medical condition that the study doctors believe might make it unsafe to participate.
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Trial locations
Where you can join this trial
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Investigated drugs
What is already known about the treatment
Investigated diseases
Type 2 Diabetes
Type 2 Diabetes is a chronic condition that affects the way the body processes blood sugar (glucose). It is characterized by insulin resistance, where the body's cells do not respond properly to insulin, and eventually, the pancreas may not produce enough insulin. Over time, high blood sugar levels can lead to various complications. The disease often develops slowly, and individuals may not notice symptoms initially. As it progresses, symptoms such as increased thirst, frequent urination, and fatigue may occur. Long-term progression can affect various organs and systems in the body.
Obesity
Obesity is a medical condition characterized by an excessive amount of body fat. It is typically measured using the Body Mass Index (BMI), where a BMI of 30 or higher is considered obese. The condition develops when calorie intake exceeds the amount of energy expended over time, leading to fat accumulation. Obesity can progress gradually and is influenced by genetic, environmental, and lifestyle factors. As it progresses, it can lead to various health issues, including joint problems and metabolic disorders. The condition can also affect physical mobility and overall quality of life.
Overweight
Overweight is a condition where an individual has more body weight than is considered healthy for their height, often due to excess body fat. It is typically assessed using the Body Mass Index (BMI), with a BMI between 25 and 29.9 classified as overweight. The condition can develop from an imbalance between calorie intake and energy expenditure. Over time, being overweight can increase the risk of developing other health conditions, such as cardiovascular diseases and type 2 diabetes. The progression of overweight can be influenced by factors such as diet, physical activity, and genetics.
sourced from the EU Clinical Trials Register and site verification
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