RECRUITING

Semaglutide Treatment in the Real-world for Fibrosis Due to NAFLD in Obesity and T2DM

Conditions

Fibrosis, Liver Type 2 Diabetes Mellitus in Obese Non-Alcoholic Fatty Liver Disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Semaglutide Treatment in the Real-world for Fibrosis Due to NAFLD in Obesity and T2DM

Quick Facts

Study Start:2023-07-25

Study Completion:2025-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06005012

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years to 79 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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. * 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. 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 al³⁰, 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	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 equation⁷⁰ 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.

Inclusion Criteria

Exclusion 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.
* 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.
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 al³⁰, 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

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 equation⁷⁰
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.

Contacts and Locations

Study Contact

Egbert Madamba

CONTACT

(858) 246-2227

emadamba@health.ucsd.edu

Principal Investigator

Rohit Loomba

PRINCIPAL_INVESTIGATOR

University of California, San Diego

Study Locations (Sites)

University of California, San Diego

La Jolla, California, 92093

United States

Collaborators and Investigators

Sponsor: University of California, San Diego

Rohit Loomba, PRINCIPAL_INVESTIGATOR, University of California, San Diego

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-25

Study Completion Date2025-06

Study Record Updates

Study Start Date2023-07-25

Study Completion Date2025-06

Terms related to this study

Additional Relevant MeSH Terms

Fibrosis, Liver
Type 2 Diabetes Mellitus in Obese
Non-Alcoholic Fatty Liver Disease