A Phase 3 Study Evaluating Efficacy and Safety of Lanifibranor Followed by an Active Treatment Extension in Adult Patients With (NASH) and Fibrosis Stages F2 and F3 ( NATiV3 )
Recruiting
This Phase 3 study is conducted to evaluate lanifibranor in adults with NASH and liver fibrosis histological stage F2 or F3
Gender:
All
Ages:
18 years and above
Trial Updated:
11/21/2023
Locations: ASHA Clinical Research - Munster, Hammond, Indiana
Conditions: NASH - Nonalcoholic Steatohepatitis
Placebo-controlled, Proof-of-concept Study to Evaluate the Safety and Efficacy of Lanifibranor Alone and in Combination With SGLT2 Inhibitor EmpaGliflozin in patiEnts With NASH and Type 2 Diabetes Mellitus
Recruiting
The study in the T2DM population is intended to confirm the lanifibranor effect versus placebo on glycemic control and assess a positive effect of the combination of lanifibranor with an SGLT2 inhibitor on glycemic control.
Gender:
All
Ages:
18 years and above
Trial Updated:
11/03/2023
Locations: Indiana University School of Medicine, Indianapolis, Indiana +1 locations
Conditions: NASH - Nonalcoholic Steatohepatitis, Diabetes Mellitus, Type 2
Non-Invasive Quantification of Liver Health in NASH (N-QUAN)
Recruiting
To evaluate, in patients with suspected NASH referred for liver biopsy, the diagnostic performance of CT1 at discriminating those with NAS≥4 & F≥2 from those without.
Gender:
All
Ages:
Between 18 years and 75 years
Trial Updated:
09/07/2023
Locations: Indiana University Health, Indianapolis, Indiana
Conditions: NASH - Nonalcoholic Steatohepatitis
Tocotrienol Against the Progression of End Stage Liver Disease
Recruiting
The purpose of this Phase 2 trial is to validate the outcome observed in a previous trial that oral Tocotrienol (TCT) attenuates the rise in MELD score over time in patients with end stage liver disease / cirrhosis. The study is double blind and participants will be randomized to take 2 capsules of TCT (200mg) or placebo twice a day for 3 years.
Gender:
All
Ages:
18 years and above
Trial Updated:
07/19/2023
Locations: IU Health Unviersity Hospital, Indianapolis, Indiana
Conditions: End Stage Liver Disease, NASH - Nonalcoholic Steatohepatitis, NAFLD - Nonalcoholic Fatty Liver Disease
Nonalcoholic Fatty Liver Disease in HIV Database
Recruiting
Nonalcoholic fatty liver disease (NAFLD) is a spectrum of liver conditions associated with fat accumulation that ranges from benign, non-progressive liver fat accumulation to severe liver injury, cirrhosis, and liver failure. The spectrum of NAFLD encompasses simple nonalcoholic steatosis (nonalcoholic fatty liver [NAFL]) and nonalcoholic steatohepatitis (NASH) in which there is evidence of hepatocellular injury and/or fibrosis. NAFLD is the most common liver disease in adults and the second lea... Read More
Gender:
All
Ages:
18 years and above
Trial Updated:
02/09/2023
Locations: Indiana University, Indianapolis, Indiana
Conditions: NAFLD, NASH - Nonalcoholic Steatohepatitis, Hiv
Non-invasive Evaluation of Portal Hypertension in Patients With Compensated Advanced Chronic Liver Disease by Assessment of Spleen Stiffness Using Vibration Controlled Transient Elastography
Recruiting
Hypothesis: The severity of portal hypertension in compensated advanced chronic liver disease (cACLD) can be assessed using vibration controlled transient elastography (VCTE) via the FibroScan® 502 Touch by measuring SS (splenic stiffness) Specific Aims: SS by VCTE will be measured in this single center clinical study comprising of 200 patients with cACLD (defined by LSM ≥10 kilopascals (kPa) according to the Baveno VI recommendations) who have not had a liver transplant and 100 subjects who are... Read More
Gender:
All
Ages:
18 years and above
Trial Updated:
11/22/2022
Locations: Indiana University School of Medicine, Indianapolis, Indiana
Conditions: Advanced Chronic Liver Disease, NASH
Safety and Efficacy of Ketogenic Diet for Promoting Weight Loss in Obese Individuals With Compensated NASH Cirrhosis
Recruiting
This is an open-label, randomized study comparing a monitored ketogenic diet intervention using standard ketogenic diet (SKD) and standard of care (SOC) dietary recommendations for 16 weeks. Subjects enrolled in the standard of care group will receive a voucher to Weight Watchers after study completion.
Gender:
All
Ages:
18 years and above
Trial Updated:
11/22/2022
Locations: Indiana University School of Medicine, Indianapolis, Indiana
Conditions: NASH - Nonalcoholic Steatohepatitis, Cirrhosis, Liver
Safety, Tolerability, and Efficacy of AXA1125 in NASH With Fibrosis
Recruiting
This study will compare the effects of AXA1125, an orally active mixture of amino acids, compared to placebo, on improving fat and inflammation (steatohepatitis) as well as fibrosis in subjects with non alcoholic steatohepatitis (NASH). as well as the safety and tolerability of AXA1125. Subjects will take one of two different doses of AXA1125 or a placebo twice daily, and a liver biopsy will be done at the beginning and end of the 48-week study.
Gender:
All
Ages:
18 years and above
Trial Updated:
09/07/2022
Locations: ASHA Clinical Research, Hammond, Indiana +1 locations
Conditions: Non Alcoholic Steatohepatitis (NASH)