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Fatty Liver clinical trials

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NCT ID: NCT05766709 Completed - Clinical trials for Non-alcoholic Steatohepatitis

A Research Study Comparing Blood Levels of Medicines NNC0194-0499 and Semaglutide Administered as a Combination Formulation Versus Two Separate Formulations

Start date: March 2, 2023
Phase: Phase 1
Study type: Interventional

Novo Nordisk is developing a combination of 2 medicines (NNC0194-0499 and semaglutide) for the treatment of nonalcoholic steatohepatitis (NASH). NASH is a serious disease where fat, inflammation and scar tissue builds up in the liver. NNC0194-0499 is a new medicine which works in the liver. Semaglutide is a well-known medicine, which is already used to treat type 2 diabetes and obesity. The study is being done to see how 2 medicines (NNC0194-0499 and semaglutide) are absorbed, transported, and eliminated from the body in a combination formulation. Participants will either get NNC0194-0499 and semaglutide in a combination formulation or the separate formulations. Which treatment participants get is decided by chance. The study will last for either 13 or 33 weeks. The duration is decided by chance.

NCT ID: NCT05765890 Completed - Clinical trials for Non-alcoholic Steatohepatitis (MASH)

Barriers to MASLD Management in Europe: Findings From a Multidisciplinary HCP-survey

BARRIERS-MASLD
Start date: March 24, 2023
Phase:
Study type: Observational

The purpose of this study is to better understand the main barriers to earlier diagnosis and better management of MASLD/MASH patients and to understand the key barriers to adoption of guidelines. This study is a cross-sectional design, conducted across 5 countries in Europe- France, Germany, Spain, United Kingdom (UK), Italy. Study participants, Hepatologists and other metabolically focused healthcare providers (HCPs), will be recruited to complete a 15 minute self-administered online survey.

NCT ID: NCT05764811 Completed - Fatty Liver Disease Clinical Trials

SGLT-2 Inhibitor Effects on Cardiac and Hepatic Metabolic Profiles for the Diabetes Patients Combined With Obesity

Start date: March 6, 2020
Phase: N/A
Study type: Interventional

Obesity is closely associated with an increased risk of cardiomyopathy because of the high metabolic activity of excessive fat while effective treatment of obesity-related cardiomyopathy is currently unsolved. Sodium-glucose cotransporter-2 inhibitors (SGLT2-i) are a class of diabetic medications. Besides improving glucose control, SGLT2-i has been shown to be able to reduce the bodyweight as well as the mortality and hospitalization rates for heart failure and cardiovascular disease in the type 2 diabetes patients. It has been proposed that the heart protection by SGLT2-i might be caused by modulating the production of adipokine and cytokine. The investigators will enrolled 40 patients (diabetes mellitus with BMI>27 Kg/m2) from obesity weight-reduction clinics: 1) 20 patients treated with SGLT2-i (CANA) and regular weight-reduction plan; 2) 20 patients with regular weight reduction plan, without CANA, for 4 weeks. The investigators will compare the variation of Fibroblast growth factor-21 (FGF21) related proteins and RNA between these 2 groups of subjects. The investigators will arrange cardiac ultrasound, hepatic MRI and fibroscan, body composition dual energy x-ray absorptiometry to evaluate the possible mechanisms underlying the liver and heart modification process, as a scientific basis for precision medicine in the future. Conclusions: SGLT2-i treatment may increase the concentration of FGF21, either in the liver or heart, thus to protect the high-fat diet induced obesity associated heart dysfunction by activating FGF21 downstream protein expression.

NCT ID: NCT05742919 Completed - Clinical trials for Non-alcoholic Fatty Liver Disease

A Research Study Looking at How a Single Dose of the Medicine NNC0194-0499 Behaves in Chinese Men

Start date: February 16, 2023
Phase: Phase 1
Study type: Interventional

This study looks at how a new study medicine called NNC0194-0499 behaves in the body of Chinese men. Three different dose levels will be tested. Participant will get only one of the three different dose levels of NNC0194-0499. Which dose participant will get will be decided by chance. NNC0194-0499 is a medicine under clinical investigation. It means that the medicine has not yet been approved by the health authorities. Participant will get 1 or 2 injections of the study medicine. It will be injected with a needle into a skin fold on stomach. The study will last for a maximum of 64 days. Participant will not be able to take part in the study if the study doctor considers there is a risk for participant's health.

NCT ID: NCT05727644 Completed - Clinical trials for Non-alcoholic Steatohepatitis (NASH)

A Research Study Looking Into Blood and Urine Levels of the Medicine NNC0194-0499 in the Body and How Well it is Tolerated in Participants With Reduced Kidney Function and Normal Kidney Function

Start date: February 15, 2023
Phase: Phase 1
Study type: Interventional

Novo Nordisk is developing the study medicine NNC0194-0499 for the treatment of non-alcoholic steatohepatitis (NASH). NASH is a serious disease where fat, inflammation and scar tissue builds up in the liver. In this study the blood and urine levels of NNC0194-0499 will be compared in people with various degrees of reduced kidney function to the blood and urine levels in people with normal kidney function, after administration of one dose of 30 milligrams (mg) NNC0194-0499. Participant will only get the study medicine in one injection into a skinfold in the thigh (subcutaneous). The study will last for about 66 days including a screening phase of up to 28 days prior to dosing.

NCT ID: NCT05712265 Completed - Clinical trials for Non-alcoholic Steatohepatitis (NASH)

Study to Evaluate the Effects of a Cytochrome P450 2C19 Inhibitor on the Pharmacokinetics of Miricorilant

Start date: January 24, 2023
Phase: Phase 1
Study type: Interventional

The primary objective of this study is to evaluate the pharmacokinetics (PK) of miricorilant in the presence and absence of the strong cytochrome P450 [(CYP) 2C19] inhibitor, fluvoxamine, in healthy participants. Participants will receive a single dose of miricorilant under fed conditions with a standard breakfast after an overnight fast alone and in combination with once-daily doses of fluvoxamine. Blood samples will be collected at regular intervals for PK and safety analysis between admission and discharge from the clinical unit.

NCT ID: NCT05694923 Completed - Fatty Liver Disease Clinical Trials

Effect of Sodium Glucose Cotransporter Inhibitors on Non Diabetic Fatty Liver Disease Patients

Fatty liver
Start date: April 1, 2023
Phase: N/A
Study type: Interventional

Non-alcoholic fatty liver disease (NAFLD) has become a major health problem worldwide with an increasing prevalence ranging from 13% in Africa to 42% in South-East Asia. The term NAFLD includes a variety of diseases, ranging from liver fat deposition in more than 5% of hepatocytes (steatosis-non-alcoholic fatty liver (NAFL)) to necroinflammation and fibrosis (non-alcoholic steatohepatitis (NASH)), which can progress into NASH-cirrhosis, and eventually to hepatocellular carcinoma 1 Lifestyle modifications remain the cornerstone of NAFLD treatment, even though various pharmaceutical interventions are currently under clinical trial. Among them, sodium-glucose co-transporter type-2 inhibitors (SGLT-2i) are emerging as promising agents. Processes regulated by SGLT-2i, such as endoplasmic reticulum (ER) and oxidative stress, low-grade inflammation, autophagy and apoptosis are all implicated in NAFLD pathogenesis 2 In non-DM patients, only a small single center study exists which studied 12 patients under dapagliflozin and 10 patients under teneligliptin, a DPP4 inhibitor, for a total of 12 weeks, showing that after this intervention period, serum transaminases were decreased in both groups, while in the dapagliflozin group, total body water and body fat decreased, leading to decreased total body weight.3

NCT ID: NCT05678582 Completed - Chronic Hepatitis Clinical Trials

Hepatic Steatosis and Chronic Hepatitis B Virus

Start date: January 1, 2023
Phase:
Study type: Observational

This study aims to evaluate the prevalence and severity of hepatic steatosis in CHB and investigate the relationship between hepatic steatosis and viral load, liver biochemistry, liver fibrosis, and inflammation in CHB

NCT ID: NCT05638737 Completed - Clinical trials for Non-Cirrhotic Non-alcoholic Steatohepatitis With Fibrosis

A Study in Participants With Non-cirrhotic NASH With Fibrosis

COSMOS
Start date: October 26, 2022
Phase: Phase 2
Study type: Interventional

This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter trial. Participants will be in the trial for up to 24 weeks, including a screening period lasting up to 8 weeks, a 12-week treatment period, and a 4-week safety follow-up period Participants are not expected to directly benefit from treatment during this trial. Participants will help researchers learn more about and how to develop AZD4831 to treat NASH.

NCT ID: NCT05611567 Completed - Obesity Clinical Trials

Endoscopic Gastric Plication Using the POSE2.0 Technique for Management of Fatty Liver Disease

Start date: January 20, 2020
Phase: N/A
Study type: Interventional

Primary Obesity Surgery Endoluminal 2.0, or POSE 2.0, (USGI Medical, San Clemente, CA) creates full-thickness plications of gastric tissue endoscopically to shorten the stomach and narrow its aperture for weight loss in patients with obesity. Adults with obesity and non-alcoholic NAFLD were allocated based on preference and motivation to undergo the POSE 2.0 procedure with lifestyle modification or lifestyle modification alone to study the impact of the POSE2.0 procedures on NAFLD parameters and metabolic profile. Co-primary endpoints included improvement in controlled attenuation parameter (CAP) and resolution of hepatic steatosis at 12 months. Secondary endpoints included total body weight loss (TBWL), change in serum measures of hepatic steatosis and insulin resistance, and device safety.