Research Center: Eastside Bariatric & General Surgery LLC
Location: 1800 Tree Ln # 350, Snellville, GA 30078, United States
Lead Researcher: Aliu Sanni MD
IRB: This study has been reviewed and approved by the Central Institutional Review Board
About the Study
The American Liver Foundation estimates that 25% of Americans have Non-alcoholic Fatty Liver Disease (NAFLD). Non-alcoholic steatohepatitis (NASH) is a more severe form of this disease, which happens when someone with excess liver fats also has hepatitis, which causes inflammation and scarring of the liver. This build-up of fat, inflammation, and scarring can lead to serious liver damage and complications such as cirrhosis, and liver failure.
Researchers at Eastside Bariatric & General Surgery LLC are investigating whether a new combination of medications could help people with NASH reduce their liver damage. The information gathered in this study will help scientists to better understand liver diseases and related illnesses, such as obesity and diabetes, and could potentially help people with NASH to receive better treatment in the future.
- Participants will receive a new potential treatment for non-alcoholic steatohepatitis at no cost.
- Participants will be compensated up to $1,500 for participating in this study.
- Participants may experience improvements in their Non-Alcoholic Steatohepatitis and potentially find relief from symptoms of non-alcoholic steatohepatitis.
- Participants will be contributing valuable information that may benefit those with non-alcoholic steatohepatitis in the future.
- Participants will be helping to advance medical research.
- If you decide to participate in the study and later feel that you no longer wish to be part of it, you can withdraw at any time.
- Any information that you provide will be kept strictly confidential, except as required by law.
- Qualified health professionals will monitor your health as it relates to the study.
Who Can Participate?
- Men and women aged 18 and above who are diagnosed with non-alcoholic steatohepatitis (NASH).
- Female participants must not currently be pregnant or breastfeeding, or planning to do so during the study’s duration
- Must not have been diagnosed with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection in the last 2 years
- Must not have been diagnosed with a chronic liver disease other than non-alcoholic steatohepatitis
- Must not have type 1 diabetes; unstable diabetic retinopathy or maculopathy (diabetic eye diseases); acute pancreatitis or chronic pancreatitis (inflamed pancreas) or thyroid disease
- Must not have a presence or history of ascites (fluid in the abdomen) variceal bleeding (bleeding of veins in the digestive tract); hepatic encephalopathy (nervous system disorder caused by severe liver disease); spontaneous bacterial peritonitis (infection of abdominal fluid) or liver transplantation
- Must not have a history of cancer within the last 5 years with the exception of non-randomized liver cancer, basal and squamous cell skin cancer
- Must not have had, or plan to have an obesity treatment with surgery or a weight loss device
- Must not have a known or suspected allergy to any drug/medication
- Must not have participated in this exact clinical trial before, or have participated in another clinical trial within 180 days before the first study visit for this study
- Must be able to attend 15 study visits at the research site over approximately 1 year, take 9 phone calls with clinic staff over 1 year
More Study Details
The study team will explain the research in its entirety but some details are:
- The study will run for a total of 19 months.
- 10 weeks at the start of the study where participants will be checked to make sure they can take part.
- 52 weeks where you will be taking the study medicines. Participants will receive one of two possible combinations of study medication or placebo medication.
- During the study, participants will be asked to:
- Come to 15 visits at the research clinic. 4 visits may take several hours. These visits can also be spread over multiple days, with fewer hours on each day. 11 visits will be shorter and will take about 1 hour.
- Have 9 phone calls with the clinic staff over 1 year.
About the Research Center:
Eastside Bariatric & General Surgery
Eastside Bariatric & General Surgery is found in Snellville, Georgia at Eastside Medical Center’s Physician Plaza where it provides a wide array of services to its patients. These include counseling, corrective surgery, and procedures, helping patients lose weight through its complete bariatric program, responding to emergency situations at the hospital, and providing surgical expertise to the patients of other doctors when called upon. The surgery also runs a comprehensive education program for medical students. Its philosophy is focused on care that leads with compassion and aims toward a positive outlook for its patients.
Due to the COVID-19 pandemic, the researchers would like to assure the participants that ensuring their and the study staff’s safety is of utmost importance.