Study to Evaluate the Effectiveness of Survodutide in Reducing Liver Fat and Weight in Patients with Obesity or Overweight and Non-Alcoholic Steatohepatitis (NASH)

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What is this study about?

This clinical trial is focused on studying the effects of a new treatment called survodutide for people who are living with obesity or are overweight and have a liver condition known as non-alcoholic steatohepatitis (NASH). NASH is a type of liver disease that occurs when fat builds up in the liver, leading to inflammation and damage. The study will compare the effects of survodutide, which is given as an injection under the skin, to a placebo. The main goal is to see if survodutide can help reduce liver fat and assist with weight loss over a period of 48 weeks.

Participants in the study will receive weekly injections of survodutide while following a reduced-calorie diet and increasing physical activity. The study will monitor changes in liver fat using a special imaging technique called MRI and track weight changes. The trial aims to provide evidence on how effective and safe survodutide is for people with NASH and obesity or overweight, especially those with related health issues like high blood pressure, high cholesterol, sleep apnea, heart disease, or type 2 diabetes.

The study will last for 48 weeks, during which participants will undergo regular assessments to measure liver fat content, body weight, and other health indicators. The results will help determine if survodutide is a beneficial treatment option for reducing liver fat and aiding weight loss in individuals with NASH and obesity or overweight. This research is important for developing new ways to manage these conditions and improve the health of those affected.

1 joining the study

Upon joining the study, participants will be randomly assigned to receive either the survodutide treatment or a placebo. This process is double-blind, meaning neither the participant nor the study team will know which treatment is being administered.

2 treatment administration

Participants will receive survodutide or a placebo through a subcutaneous injection. This is an injection given under the skin.

The injection will be administered once a week for a total duration of 48 weeks.

3 diet and physical activity

Participants are required to follow a reduced-calorie diet and increase their physical activity throughout the study period. This is to support the treatment and help achieve the study’s objectives.

4 monitoring and assessments

Regular monitoring will occur to assess the effects of the treatment. This includes measuring liver fat content and body weight changes.

Liver fat content will be assessed using a technique called MRI-PDFF, which is a type of imaging that helps visualize fat in the liver.

Body weight and other health parameters will be monitored to evaluate the treatment’s impact.

5 end of study

At the end of the 48-week period, final assessments will be conducted to determine the overall effectiveness and safety of the treatment.

Participants will receive information about their health status and any relevant findings from the study.

Who Can Join the Study?

Must be at least 18 years old or older, depending on the legal age of consent in your country.
Have a Body Mass Index (BMI) of 30 or higher, or a BMI of 27 or higher with at least one weight-related health issue such as:
- Hypertension: High blood pressure, either untreated or controlled with medication.
- Dyslipidaemia: Abnormal levels of fats in the blood, requiring treatment or having specific cholesterol or triglyceride levels.
- Obstructive sleep apnoea: A condition where breathing stops and starts during sleep.
- Cardiovascular disease: Includes heart failure, history of stroke, heart attack, or other heart-related conditions.
- Type 2 Diabetes Mellitus (T2DM): Diagnosed at least 180 days before the study, with specific blood sugar levels.
Have presumed or confirmed NASH (a liver condition) with evidence of liver fat and no other causes of liver fat buildup. This can be shown by:
- Specific scores or measurements from liver tests or scans.
- A recent liver biopsy showing certain liver changes.
Have tried at least once to lose weight through diet but were not successful.

Who Cannot Join the Study?

Individuals who are not within the specified age range for the study.
Individuals who do not have a Body Mass Index (BMI) of 27 or higher. BMI is a measure that uses height and weight to estimate body fat.
Individuals who do not have obesity-related health issues such as high blood pressure, abnormal cholesterol levels, sleep apnea, heart disease, or type 2 diabetes.
Individuals who are not able to follow a reduced-calorie diet and increased physical activity plan.
Individuals who have medical conditions that could interfere with the study or pose a risk to their health.
Individuals who are pregnant or breastfeeding.
Individuals who are participating in another clinical trial.
Individuals who have a history of substance abuse or mental health issues that could affect their ability to participate in the study.
Individuals who have allergies or reactions to the study medication or similar drugs.
Individuals who have had recent surgery or plan to have surgery during the study period.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany

Other Sites

Site Name	City	Country
PROFIL Institut fuer Stoffwechselforschung GmbH	Neuss	Germany
Hospital Universitario Ramon Y Cajal	Madrid	Spain
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
Hospital Clinic De Barcelona	Barcelona	Spain
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Stichting Treant Ziekenhuiszorg	Emmen	The Netherlands
Afygncafl Uux	Amsterdam	The Netherlands
Eqwjrnj Uatufvlrlxdc Mtedutt Cgxhqvx Rtehspewj (whnabpy Mpz	Rotterdam	The Netherlands
Gxysti Udnwggqslp Fvwgtobxe	Frankfurt	Germany
Fdjrfhanm Plob Lc Iwpsbfvzlkzcg Bjvxsgofm Djd Hykvcolh Umvyybiuwsosc Ln Pru	Madrid	Spain
Hdzpyuek Vkbw dqjgvveq	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	15.06.2024
Spain	Not recruiting	15.06.2024
The Netherlands	Not recruiting	15.06.2024

Trial locations

Investigated drugs:

Survodutide is a medication being studied for its potential to help people with overweight or obesity, particularly those with a liver condition called nonalcoholic steatohepatitis (NASH). In this trial, survodutide is given as an injection under the skin once a week. The goal is to see if it can reduce liver fat and help with weight loss when combined with a diet lower in calories and increased physical activity. The study is looking at how well survodutide works and how safe it is for the participants.

Investigated diseases:

Obesity

Obesity – Obesity is a condition characterized by excessive body fat accumulation that may impair health. It is typically defined by a body mass index (BMI) of 30 or higher. Obesity develops over time when a person consumes more calories than they burn, leading to an energy imbalance. This condition can lead to various health complications, including heart disease, diabetes, and sleep apnea. It often progresses gradually, with weight gain occurring over months or years. Lifestyle factors, genetics, and certain medical conditions can contribute to the development of obesity.

Trial ID:

2023-505303-23-00

Protocol code:

1404-0056

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study to Evaluate the Effectiveness of Survodutide in Reducing Liver Fat and Weight in Patients with Obesity or Overweight and Non-Alcoholic Steatohepatitis (NASH)

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?