Not recruiting

Study of Retatrutide for Patients with Obesity, Overweight, and Chronic Low Back Pain

Fast replyInvestigationalNo placebo

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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 on individuals who have obesity or are overweight and also suffer from chronic low back pain. The treatment being tested is a solution for injection that is administered under the skin. The study aims to determine if Retatrutide is more effective than a placebo in reducing pain intensity and body weight.

Participants in the study will receive either Retatrutide or a placebo once a week. The study will last for a period of up to 72 weeks, during which the effects of the treatment on pain levels and body weight will be monitored. The goal is to see if Retatrutide can help reduce the average pain intensity and assist in weight loss for those who have struggled to lose weight through diet changes alone.

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 approach helps ensure the results are unbiased and reliable. The trial is expected to provide valuable insights into the potential benefits of Retatrutide for individuals dealing with obesity, overweight, and chronic low back pain.

The research process

The trial runs in 5 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 receive either the study medication, Retatrutide, or a placebo. A placebo is a substance that looks like the medication but does not contain the active ingredient.
The study is designed to be double-blind, meaning neither you nor the study team will know which treatment you are receiving. This helps ensure the results are unbiased.
Step 2
Medication administration
You will receive the medication as a subcutaneous injection, which means it is injected under the skin. This will be done once a week.
The medication is provided as a solution for injection and will be administered by a healthcare professional.
Step 3
Duration of treatment
The treatment will continue for up to 72 weeks. During this time, you will have regular appointments to monitor your progress and any changes in your condition.
Step 4
Monitoring and assessments
Throughout the study, your pain intensity and body weight will be regularly assessed. This will help determine the effectiveness of the treatment.
You will be asked to report your average pain intensity using a numeric rating scale. This will be done at the start of the study and at various points throughout the 72 weeks.
Step 5
End of study
At the end of the study period, you will have a final assessment to evaluate the overall impact of the treatment on your condition.
The study is expected to conclude by January 25, 2027.

Who can join the trial?

5 criteria

Must have had low back pain for at least the last 6 months.
Must be overweight. This means having more body weight than is considered healthy for your height.
Must have tried to lose weight by changing what you eat, but it did not work.
Both men and women can participate.
Participants can be from a vulnerable population. This means people who might need extra care or protection.

Who cannot join the trial?

3 criteria

Patients who are not within the specified age range for the study.
Patients who are not experiencing obesity, overweight, or chronic low back pain (long-lasting pain in the lower back).
Patients who are part of a vulnerable population, which means they might need special protection or care.

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Verified sites

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

Verified
Centrum Badan Klinicznych Pi-House Sp. z o.o.
Gdansk, Poland
Responsive
Diamond Clinic Sp. z o.o.
Cracow, Poland
Not recruiting
Verified
Santa Sp. z o.o.
Lodz, Poland

Trial locations

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Investigated drugs

Retatrutide is a medication being studied for its potential to help people who are overweight or have obesity, especially those who also suffer from chronic low back pain. This medication is taken once a week and is being tested to see if it can reduce both body weight and the intensity of pain. The goal is to see if it can provide relief from pain while also helping with weight loss, which could improve overall health and quality of life for participants in the trial.

Ly3437943 Sodium

What is already known about the treatment

Retatrutide – Retatrutide is administered as a once-weekly injection, designed to help people who are obese or overweight, and those suffering from chronic low back pain. Currently, it is being studied in clinical trials to assess its effectiveness and safety compared to a placebo. The main goal of using Retatrutide is to reduce body weight and alleviate pain. It works by targeting specific pathways in the body that regulate appetite and pain perception, helping to decrease hunger and manage pain. Retatrutide is classified as a medication for weight management and pain relief.

Investigated diseases

Obesity
Obesity is a condition characterized by excessive body fat accumulation that may negatively impact health. It develops when calorie intake consistently exceeds calorie expenditure, leading to an energy imbalance. Over time, this imbalance results in the storage of excess energy as fat. The progression of obesity can lead to increased body mass index (BMI) and changes in body composition. As obesity advances, it may contribute to the development of other health issues. The condition is often associated with lifestyle factors, including diet and physical activity levels.
Overweight
Overweight is a condition where an individual has more body weight than is considered healthy for their height, primarily due to excess body fat. It occurs when there is a prolonged imbalance between calorie intake and energy expenditure. This condition can gradually progress as the body stores excess calories as fat. Over time, being overweight can lead to changes in body composition and increased body mass index (BMI). The progression of overweight status can be influenced by lifestyle factors such as diet and physical activity. It is often considered a precursor to obesity if not managed.
Chronic Low Back Pain (CLBP)
Chronic Low Back Pain is a persistent pain condition affecting the lower back region, lasting for more than three months. It often develops gradually and can be caused by various factors, including muscle strain, spinal issues, or degenerative changes. The pain may fluctuate in intensity and can be influenced by physical activity, posture, and stress. Over time, CLBP can lead to reduced mobility and functional limitations. The condition may also affect an individual's ability to perform daily activities. It is a common musculoskeletal disorder that can impact quality of life.