Study of Retatrutide (LY3437943) for Patients with Obesity or Overweight and Knee Osteoarthritis

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What is this study about?

This clinical trial is focused on studying the effects of a new treatment called Retatrutide (also known by its code name LY3437943) for individuals who have obesity or are overweight, and also suffer from osteoarthritis of the knee. Osteoarthritis is a condition that causes pain and stiffness in the joints, and it commonly affects the knees. The purpose of the study is to see if Retatrutide can help reduce knee pain and assist with weight loss.

Participants in the study will receive Retatrutide as a solution for injection, which means it will be given as a shot under the skin. The study will compare the effects of Retatrutide to a placebo, which is an inactive substance. The trial will be conducted in a way that neither the participants nor the researchers know who is receiving the actual treatment or the placebo, ensuring unbiased results. The study will last for a certain period, during which participants will receive the treatment once a week.

The main goal of the study is to determine if Retatrutide is more effective than the placebo in reducing knee pain and helping with weight loss. Participants will be monitored for changes in their knee pain using a specific scale and for any changes in their body weight. This study aims to provide valuable information on the potential benefits of Retatrutide for people dealing with both obesity and knee osteoarthritis.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying a history of unsuccessful dietary efforts to lose weight and the presence of knee pain for more than 12 weeks.

2 randomization

Participants are randomly assigned to receive either the study medication, Retatrutide, or a placebo injection. This process is double-blind, meaning neither the participant nor the study team knows which treatment is being administered.

3 treatment phase

The treatment involves a subcutaneous injection of Retatrutide or placebo once a week. The dosage of Retatrutide is either 9 mg or 12 mg, depending on the group assignment.

This phase continues throughout the study duration, with regular monitoring of health and progress.

4 monitoring and assessments

Participants undergo regular assessments to monitor changes in knee pain and body weight. These assessments use the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score and body weight measurements.

The primary goal is to observe any changes from the baseline measurements.

5 completion of study

The study is estimated to conclude by November 6, 2025. Upon completion, participants may receive information about the treatment they received and the overall study results.

Who Can Join the Study?

Be overweight. This means having more body weight than is considered healthy for your height.
Have a history of at least one self-reported unsuccessful attempt to lose weight through diet.
Experience knee pain for more than 12 weeks before the screening process.
Both men and women can participate.
Participants should be within certain age ranges, typically adults and older adults.

Who Cannot Join the Study?

Patients who have a history of severe allergic reactions to any of the study medications.
Individuals with uncontrolled high blood pressure, which means their blood pressure is not well-managed with medication or lifestyle changes.
People with a history of heart attack or stroke within the last 6 months.
Patients with severe liver disease, which affects how the liver functions.
Individuals with severe kidney disease, which affects how the kidneys work.
Women who are pregnant or breastfeeding.
Patients currently participating in another clinical trial.
Individuals with a history of drug or alcohol abuse within the past year.
People with certain mental health conditions that are not stable or well-managed.
Patients who have had surgery on their knee within the last 6 months.
Individuals with any other medical condition that the study doctors believe would make it unsafe for them to participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

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Other Sites

Site Name	City	Country
Nuevas Tecnologias En Diabetes Y En Endocrinologia S.L. Profesional	Sevilla	Spain
Hospital Universitario Reina Sofía	Cordoba	Spain
Hospital General Universitario De Valencia	Valencia	Spain
Area Sanitaria De Ferrol	Ferrol	Spain
Hospital Quironsalud Malaga	Malaga	Spain
Hospital Universitario Infanta Sofía	San Sebastian De Los Reyes	Spain
Hpdomkfr Dh Lg Swzoj Cmlm I Swyn Psd	Barcelona	Spain
Hrorymnz Ufkuixlbvtczb dg A Ckjbky	A Coruna Galicia	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not recruiting	13.10.2023

Trial locations

Investigated drugs:

Ly3437943 Sodium

LY3437943: This is an investigational medication being studied for its potential to help people who are overweight or have obesity, and also suffer from osteoarthritis of the knee. The trial aims to see if this medication can reduce knee pain and help with weight loss when taken once a week.

Investigated diseases:

Osteoarthritis, Knee – This is a degenerative joint disease that affects the knee, leading to the breakdown of cartilage. As the cartilage wears away, bones may rub against each other, causing pain and stiffness. Over time, the joint may become swollen and lose its normal shape. The condition can lead to decreased mobility and difficulty in performing daily activities. It often progresses slowly, with symptoms worsening over the years. Factors such as age, weight, and previous joint injuries can influence its development.

Obesity – This condition is characterized by an excessive amount of body fat, which can negatively impact health. It is typically measured using the Body Mass Index (BMI), where a BMI of 30 or higher is considered obese. Obesity can develop gradually over time due to factors like poor diet, lack of physical activity, and genetic predisposition. It can lead to various health issues, including joint problems, as excess weight puts additional stress on the body. The condition can also affect energy levels and overall quality of life. Managing weight through lifestyle changes is often necessary to address obesity.

Overweight – This condition occurs when a person has more body weight than is considered healthy for their height, often due to excess body fat. It is usually determined by a Body Mass Index (BMI) between 25 and 29.9. Being overweight can develop from a combination of factors, including poor diet, lack of exercise, and genetic influences. It can increase the risk of developing other health conditions, such as heart disease and diabetes. The progression of being overweight can lead to obesity if not managed. Maintaining a balanced diet and regular physical activity are key to managing this condition.

Trial ID:

2023-503660-17-00

Protocol code:

J1I-MC-GZBN

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of Retatrutide (LY3437943) for Patients with Obesity or Overweight and Knee Osteoarthritis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?