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Tesamorelin for Non-alcoholic Fatty Liver Disease
Study Summary
This trial is investigating whether a drug called tesamorelin, which helps the body produce growth hormone, can reduce the amount of fat in the liver and improve liver inflammation in people with obesity and nonalcoholic fatty liver disease.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2008 Phase 3 trial • 263 Patients • NCT00608023Trial Design
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Who is running the clinical trial?
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- I have diabetes or high blood sugar, or I'm taking medication for it.I have been diagnosed with a specific liver condition.I have been taking vitamin E (≥400 IU daily) for at least 6 months.I regularly use Actigall, methotrexate, amiodarone, or tamoxifen.I currently have cancer.I haven't changed my cholesterol or blood pressure medication in the last 2 months.I have been on stable hormone therapy for over a year.I am considering a treatment that involves significant radiation in the next year.I am unable to follow the treatment plan as required.I am between 18 and 65 years old.I am a woman over 50 and had a negative mammogram in the last year.I have been taking vitamin E (≥400 IU daily) for at least 6 months.I have not used growth hormone treatments in the last 6 months.I am a man with prostate cancer or my PSA level is above 5 ng/mL.I have a condition that affects my growth hormone levels.I had weight loss surgery over a year ago without losing more than 10% of my weight recently.I am not pregnant, trying to get pregnant, or breastfeeding.I am up to date with my colon cancer screenings as recommended by my doctor.I cannot take beta-blockers or nitroglycerin due to health reasons.I do not have active hepatitis B or C.I have not used corticosteroids regularly in the last 6 months.I have not had significant radiation exposure or multiple specific heart or imaging tests in the last year.I have severe liver disease or cirrhosis.I have not used any specific drugs for fatty liver disease except vitamin E.My liver shows signs of fatty changes without significant weight loss or new medications.
- Group 1: Tesamorelin
- Group 2: Placebo
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What are the conditions that Tesamorelin is commonly used to improve?
"Tesamorelin is an effective medical intervention for patients with general surgery, short stature, and open epiphyses."
Has Tesamorelin cleared all the necessary government regulations for public use?
"While there is some clinical data indicating Tesamorelin's safety, it has not been proven effective yet and thus received a score of 2."
How many individuals are in the process of testing this new medication?
"The listing on clinicaltrials.gov corroborates that this study is looking for enrollees. This trial was first advertised on 1/17/2019, with the most recent update being on 8/11/2022. They are recruiting for a total of 76 patients from a single location."
What other trials are similar to this one?
"BioPartners GmbH conducted the first clinical trial for Tesamorelin in 2005 with 144 participants. After the successful initial study,Tesamorelin received Phase 3 drug approval and has since been further researched in 38 active trials across 45 countries."
How can I get involved in this experiment?
"This study is currently enrolling 76 individuals who are between 18-65 years old, have obesity, and visceral fat. Additionally, it is essential that participants meet the following qualifications: Up to date with colon cancer screening (as recommended by a primary care physician), Men and women 18-65yo, Body mass index (BMI) ≥ 30kg/m2, or, for participants with known steatohepatitis, BMI ≥ 25kg/m2, Hepatic steatosis as demonstrated by either a) Grade 1+ steatosis on a liver biopsy performed within 12 months of the baseline visit, without >10"
What is the research history of Tesamorelin?
"Presently, 38 clinical trials are underway to study Tesamorelin. Of these live trials, 14 have reached Phase 3 testing. Although the majority of these trials originated in Philadelphia, Pennsylvania; 653 locations across the world are running studies for this medication."
Is this study currently enrolling new participants?
"That is correct, the online information does show that the trial is still active and looking for subjects. The posting date was January 17th, 2019 with the most recent update on August 11th, 2022. They have only 1 site listed but are hoping to find 76 individuals total."
At what age do patients need to be in order to participate in this trial?
"Eligibility for this clinical trial is restricted to patients aged 18-65. Out of the 1,208 similar trials available, 256 are for patients younger than Majority and 952 are for those 65 and over."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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