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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date September 2023
Source University of California, San Diego
Contact Egbert Madamba
Phone (858) 246-2227
Email emadamba@health.ucsd.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

Nonalcoholic fatty liver disease (NAFLD) affects approximately 25-30% of the global population and is projected to become the leading cause of liver transplantation in the United States by 2030. Development of efficient screening strategies for the identification and treatment of individuals who are at greatest risk for advanced disease in this population is an urgent and unmet medical need. Type 2 diabetes mellitus (T2DM) and obesity are critical risk factors for advanced NAFLD. In a prospective cross-sectional study of patients with type 2 diabetes, we screened 524 participants (50-80 years old) with type 2 diabetes mellitus for the presence of NAFLD and observed relative prevalences of 70% for steatosis and 15% for advanced fibrosis. The presence of obesity in this population further increased the odds of advanced fibrosis. These findings suggest that screening populations of individuals with obesity or T2DM may be an effective strategy for identifying high-risk patients with NAFLD. Semaglutide is a glucagon-like peptide 1 receptor agonist (GLP-1 RA) that is FDA-approved for the treatment of obesity (as Wegovy) or T2DM (as Ozempic), conditions that are considered major risk factors for advanced fibrosis in the NAFLD population. It is unclear, however, whether semaglutide is effective for treatment of fibrosis due to NAFLD in these populations. Here, the investigators propose to 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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Semaglutide
Semaglutide is a glucagon-like peptide 1 receptor agonist (GLP-1 RA) that is FDA-approved for the treatment of obesity (as Wegovy) or T2DM (as Ozempic).
Placebo
Placebo

Locations

Country Name City State
United States University of California, San Diego La Jolla California

Sponsors (1)

Lead Sponsor Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

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
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