Non-Alcoholic Fatty Liver Disease Clinical Trial
— SAMARAOfficial title:
Semaglutide Treatment in the Real-world for Fibrosis Due to NAFLD in Obesity and T2DM
NCT number | NCT06005012 |
Other study ID # | NRC-2023-1 |
Secondary ID | |
Status | Recruiting |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | July 25, 2023 |
Est. completion date | June 2025 |
Conduct a community intervention study that will 1) validate a screening approach to identify patients at risk for advanced NAFLD in the obese or T2DM population, and 2) test whether semaglutide treatment is effective for the management of significant fibrosis due to NAFLD in high-risk patients.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | June 2025 |
Est. primary completion date | March 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 79 Years |
Eligibility | Inclusion criteria: 1. Adult, age = 40 and < 80 years 2. Participant must meet at least one of following sets of conditions: 1. BMI = 27 kg/m² OR 2. BMI = 25 kg/m² AND presence of i) pre-diabetes (HbA1C = 5.7) or ii) type 2 diabetes mellitus (T2DM), as defined by the American Diabetes Association (ADA) clinical practice recommendations. The ADA definition of T2DM is applicable if one of the following criteria is met: - Presence of diabetes symptoms (polyuria, polydipsia, polyphagia, increased fatigue, weight loss, blurred vision) and casual plasma glucose = 200 mg/dL (11.1 mmol/L) - Fasting plasma glucose (FPG) = 126 mg/dl (7.0 mmol/L) - Plasma glucose = 200 mg/dL (11.1 mmol/L) during a 75-g oral glucose tolerance test (OGTT)68. If any of the above test results occur, testing should be repeated on a different day to confirm the diagnosis. OR • Hemoglobin A1C (HbA1C) = 6.5% 6?. 3. FAST score = 0.5 and VCTE = 8.0 kPa; FAST score threshold based on data from MAESTRO-NASH trial4²; VCTE cutpoint based on AASLD guidelines for identification of patients with significant fibrosis risk. 4. Participants without a VCTE assessment in their medical record may qualify for the study if they have a FIB-4 = 1.0, which is a cutpoint based on observations of patients with T2DM in Ajmera et al³°, and VCTE = 8.0 kPa. 5. The subject is fully informed and willing and able to perform all the procedures specified in the protocol and has signed a written informed consent to participate Exclusion criteria: 1. Presence of regular and/or excessive use of alcohol, defined as > 30 g/day for males and > 20 g/day for females, for a period longer than 2 years at any time in the last 10 years 2. Evidence of cirrhosis or previously known cirrhosis, based on the results from previous liver biopsy or history of portal hypertension presented by ascites, hepatic encephalopathy or varices 3. VCTE = 20 kPa 4. Platelet count = 140,000 per Ml 5. Albumin < 3.6 g/dL 6. INR > 1.35, unless on coumadin for another indication 7. Serum creatinine > 2.0 mg/dL 8. eGFR < 30 mL/min/1.73 m² as defined according to the CKDEPI creatinine equation7° 9. Use of other weight loss medications, including GLP1RA within the last 90 days 10. Greater than 10% weight loss in the prior six months 11. Known or suspected hypersensitivity to GLP1RA medications including semaglutide 12. History of bariatric surgery within the past 5 years or expected bariatric surgery 13. Evidence of other causes of chronic liver disease including: 1. Hepatitis B, as defined as presence of hepatitis B surface antigen (HBsAg). 2. Previous or current infection with Hepatitis C, as defined by presence of hepatitis C virus Ab in serum (anti-HCV Ab). 3. Autoimmune hepatitis, as defined by anti-nuclear antibody (ANA) of 1:160 or greater and liver histology consistent with autoimmune hepatitis or previous response to immunosuppressive therapy. 4. Autoimmune cholestatic liver disorders, as defined by elevation of alkaline phosphatase and anti- mitochondrial antibody of greater than 1:80 or liver histology consistent with primary biliary cirrhosis or elevation of alkaline phosphatase and liver histology consistent with sclerosing cholangitis. 5. Wilson disease, as defined by ceruloplasmin below the limits of normal and liver histology consistent with Wilson disease deficiency, as defined by alpha-1-antitrypsin phenotype and liver histology consistent with alpha-1-antitrypsin deficiency. |
Country | Name | City | State |
---|---|---|---|
United States | University of California, San Diego | La Jolla | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Diego |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in fibrosis due to NAFLD | Change in fibrosis due to Nonalcoholic fatty liver disease (NAFLD), as measured by change in FAST Score, which combines FibroScan results with aspartate aminotransferase (AST). | 52 weeks | |
Secondary | Change in liver stiffness | Change in liver stiffness, as measured by change in Vibration-Controlled Transient Elastography | 52 weeks | |
Secondary | Change in steatosis | Change in steatosis, as measure by a change in proton density fat fraction or controlled attenuation parameter | 52 weeks | |
Secondary | Change in ALT | Change in ALT, as measured by a change in patients with ALT >= 30 U/L at baseline | 52 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05480696 -
Soluble Fibre Supplementation in NAFLD
|
Phase 1 | |
Active, not recruiting |
NCT02500147 -
Metformin for Ectopic Fat Deposition and Metabolic Markers in Polycystic Ovary Syndrome (PCOS)
|
Phase 4 | |
Completed |
NCT04671186 -
Role of Probiotics in Treatment of Pediatric NAFLD Patients by Assessing With Fibroscan
|
N/A | |
Recruiting |
NCT05979779 -
Ph 2 Study of the Safety and Efficacy of Three HU6 Dose Levels and Placebo in Nonalcoholic Steatohepatitis
|
Phase 2 | |
Recruiting |
NCT05462353 -
Study to Evaluate the Safety, Tolerability, and Efficacy of ASC41 Tablets in Adult Patients With NASH
|
Phase 2 | |
Completed |
NCT05006885 -
ALT-801 in Diabetic and Non-Diabetic Overweight and Obese Subjects With Non-alcoholic Fatty Liver Disease (NAFLD)
|
Phase 1 | |
Completed |
NCT04117802 -
Effects of Maple Syrup on Gut Microbiota Diversity and Metabolic Syndrome
|
N/A | |
Recruiting |
NCT04365855 -
The Olmsted NAFLD Epidemiology Study (TONES)
|
N/A | |
Recruiting |
NCT05618626 -
Prevention of NAFLD and CVD Through Lifestyle Intervention
|
N/A | |
Completed |
NCT03256526 -
6-week Safety and PD Study in Adults With NAFLD
|
Phase 2 | |
Enrolling by invitation |
NCT06152991 -
Clinical Trial Assessing Godex Carnitine Orotate Complex in Nonalcoholic Fatty Liver Disease Patients for Efficacy
|
Phase 3 | |
Completed |
NCT03681457 -
Evaluation of the Pharmacokinetics of Tropifexor in Subjects With Mild, Moderate, or Severe Hepatic Impairment Compared to Healthy Control Subjects
|
Phase 1 | |
Completed |
NCT06244550 -
Clinical Trials Using HepatoKeeper Herbal Essentials to Treat Non-alcoholic Fatty Liver Disease and Metabolic Factors
|
N/A | |
Not yet recruiting |
NCT05120557 -
Point-of-care Ultrasound Screening and Assessment of Chronic Liver Diseases and NASH
|
N/A | |
Completed |
NCT03060694 -
Screening Diabetes Patients for NAFLD With Controlled Attenuation Parameter and Liver Stiffness Measurements
|
||
Completed |
NCT02526732 -
Hepatic Inflammation and Physical Performance in Patients With NASH
|
N/A | |
Recruiting |
NCT01988441 -
The Influence of Autophagy on Fatty Liver
|
||
Recruiting |
NCT01680003 -
Hepar-P Study to Evaluate the Safety and Efficacy of a Standardised Extract of Phyllanthus Niruri for the Treatment of Non-alcoholic Fatty Liver Disease
|
Phase 2 | |
Completed |
NCT01712711 -
Helicobacter Pylori Eradication in Diabetic Subjects With Non-alcoholic Fatty Liver Disease
|
Phase 2 | |
Recruiting |
NCT00941642 -
Placebo Controlled Study Using Lovaza as Treatment for Non-Alcoholic Fatty Liver Disease
|
Phase 4 |