Study of Retatrutide for Patients with Type 2 Diabetes and Obesity or Overweight

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What is this study about?

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.

1 joining the study

Upon joining the study, you will be randomly assigned to receive either the study medication, Retatrutide, or a placebo injection. A placebo is an injection that looks like the medication but does not contain the active substance.

2 medication administration

You will receive the medication or placebo as a subcutaneous injection, which means it is injected under the skin. This will be done once a week.

The medication, Retatrutide, is provided as a solution for injection. The exact dosage and duration will be determined by the study protocol and your healthcare provider.

3 monitoring and follow-up

Throughout the study, your health and response to the treatment will be closely monitored. This includes regular check-ups and assessments to evaluate the efficacy and safety of the treatment.

You will be asked to attend scheduled visits where various health parameters, such as body weight and blood sugar levels, will be measured.

4 completion of the study

The study is expected to continue until October 2025. Upon completion, you will have a final assessment to review your overall health and any changes observed during the study.

The primary goal is to assess the percent change from baseline in body weight and other health indicators.

Who Can Join the Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country
Gama Diamed S.R.L.	Mangalia	Romania
Hospital Universitario De Leon	Leon	Spain
Easydiet S.R.L.	Bucharest	Romania
Hospital Universitario Principe De Asturias	Alcala De Henares	Spain
Virgen del Rocío University Hospital	Sevilla	Spain
Nutrilife S.R.L.	Bucharest	Romania
Mediab S.R.L.	Targu Mures	Romania
Hospital Universitario Torrecardenas	Almeria	Spain
Sc Cmi Dr. Pletea Noemi S.R.L.	Bacau	Romania
Diabdana S.R.L.	Oradea	Romania
Hospital Universitario Virgen De La Victoria	Malaga	Spain

Trial status

Country	Status	Recruitment Start
Romania	Not recruiting	25.08.2023
Spain	Not recruiting	25.08.2023

Trial locations

Investigated drugs:

Ly3437943 Sodium

Retatrutide is a medication being studied for its potential to help people with type 2 diabetes who are also dealing with obesity or being overweight. This medication is taken once a week and is designed to help manage blood sugar levels and possibly aid in weight loss. The goal of the trial is to see how well retatrutide works in improving these health conditions and to ensure it is safe for patients to use.

Investigated diseases:

Type 2 diabetes mellitus

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.

Trial ID:

2023-503658-11-00

Protocol code:

J1I-MC-GZBK

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of Retatrutide for Patients with Type 2 Diabetes and Obesity or Overweight

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?