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Study on Dapiglutide for Weight Loss in Adults with Obesity

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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 new treatment for obesity. The treatment being tested is called dapiglutide, which is a solution for injection. The study will compare the effects of dapiglutide with a placebo to see how it impacts body weight. The main goal is to evaluate how different doses of dapiglutide, specifically 4 mg and 6 mg, affect weight loss in participants.

Participants in the study will receive either dapiglutide or a placebo through injections. 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 study will monitor changes in body weight as the primary measure of effectiveness, with additional observations on other health markers such as gut permeability and inflammation levels.

The trial aims to provide valuable insights into the potential of dapiglutide as a treatment for obesity, helping to determine its effectiveness and safety. The study is expected to run for a period of time, during which participants will be closely monitored to assess the impact of the treatment on their weight and overall health.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be randomly assigned to one of two groups. One group will receive the study medication, dapiglutide, and the other group will receive a placebo, which looks like the medication but does not contain the active ingredient.
The study is double-blind, meaning neither you nor the researchers will know which group you are in. This helps ensure the results are unbiased.
Step 2
Medication administration
If you are in the group receiving dapiglutide, you will be given the medication as a solution for injection. The medication is administered through a small needle under the skin, a method known as subcutaneous use.
The dosage will be either 4 mg or 6 mg, and the frequency and duration of administration will be explained to you by the study team.
Step 3
Monitoring and assessments
Throughout the study, your body weight will be regularly monitored to evaluate any changes. This is the primary focus of the study.
Additional assessments will include measuring changes in certain blood markers related to gut health and inflammation, such as high-sensitivity CRP and interleukin-6.
Step 4
Study duration
The study is expected to continue until July 31, 2024. During this time, you will be required to attend regular appointments as scheduled by the study team.
It is important to adhere to the study schedule and follow all instructions provided by the study team to ensure the accuracy and reliability of the study results.

Who can join the trial?

3 criteria

Age between 18 and 75 years.
BMI (Body Mass Index) of 30 kg/m² or higher. BMI is a measure that uses your height and weight to work out if your weight is healthy.
Have tried to lose weight at least once in the past.

Who cannot join the trial?

10 criteria

Patients who are not within the age range of 18 to 65 years cannot participate.
Patients who are pregnant or breastfeeding are not eligible.
Patients with a history of severe heart disease cannot join the study.
Patients with uncontrolled high blood pressure are excluded.
Patients with a history of cancer in the past 5 years cannot participate.
Patients with severe liver or kidney disease are not eligible.
Patients who have had weight loss surgery in the past year cannot join.
Patients who are currently participating in another clinical trial are excluded.
Patients with a history of drug or alcohol abuse in the past year cannot participate.
Patients with any other medical condition that the study doctors think would make it unsafe for them to participate are not eligible.

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Verified sites

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Gentofte Hospital
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Hellerup, Denmark

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Investigated drugs

Dapiglutide is a medication being studied for its potential to help people lose weight. It is designed to work by influencing the body's natural processes that control hunger and how the body uses energy. In this trial, researchers are looking at how effective dapiglutide is in helping people reduce their body weight. The goal is to see if it can be a useful treatment for obesity, which is a condition where a person has too much body fat that might affect their health. By taking dapiglutide, participants may experience changes in their appetite and metabolism, which could lead to weight loss.

DAPIGLUTIDE

What is already known about the treatment

Dapiglutide – Dapiglutide is administered as an injection, typically under the skin, and is currently being studied in clinical trials for its potential to help with weight loss in individuals with obesity. It is not yet widely available in medical practice, as it is still under investigation. The main purpose of dapiglutide is to aid in reducing body weight by influencing certain hormones that control appetite and food intake. It belongs to a class of drugs known as GLP-1 receptor agonists, which work by mimicking the action of a natural hormone in the body to help regulate blood sugar and appetite.

Investigated diseases

Obesity – Obesity is a medical condition characterized by an excessive accumulation of body fat, which can negatively impact health. It develops when there is an imbalance between calorie intake and energy expenditure, leading to weight gain. Over time, this excess weight can strain the body's systems, affecting metabolism and increasing the risk of other health issues. The progression of obesity can lead to increased fat storage in various parts of the body, including around internal organs. As the condition advances, it may contribute to the development of metabolic disorders and impact physical mobility. Obesity is often associated with changes in hormone levels and inflammation within the body.