Semaglutide Treatment in the Real-world for Fibrosis Due to NAFLD in Obesity and T2DM (SAMARA)
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ClinicalTrials.gov Identifier: NCT06005012 |
Recruitment Status :
Recruiting
First Posted : August 22, 2023
Last Update Posted : September 7, 2023
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Condition or disease | Intervention/treatment | Phase |
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Fibrosis, Liver Type 2 Diabetes Mellitus in Obese Non-Alcoholic Fatty Liver Disease | Drug: Semaglutide Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 120 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Semaglutide Treatment in the Real-world for Fibrosis Due to NAFLD in Obesity and T2DM |
Actual Study Start Date : | July 25, 2023 |
Estimated Primary Completion Date : | March 2025 |
Estimated Study Completion Date : | June 2025 |
Arm | Intervention/treatment |
---|---|
Experimental: Semaglutide
2.4 mg weekly for 52 weekly in a 3 ml PDS290 pen-injector containing Semaglutide 3.0 mg/ml for subcutaneous use
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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 Comparator: Placebo
2.4 mg weekly for 52 weekly in a 3 ml PDS290 pen-injector containing 3.0 mg/ml of a placebo solution for subcutaneous use
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Drug: Placebo
Placebo |
- Change in fibrosis due to NAFLD [ Time Frame: 52 weeks ]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).
- Change in liver stiffness [ Time Frame: 52 weeks ]Change in liver stiffness, as measured by change in Vibration-Controlled Transient Elastography
- Change in steatosis [ Time Frame: 52 weeks ]Change in steatosis, as measure by a change in proton density fat fraction or controlled attenuation parameter
- Change in ALT [ Time Frame: 52 weeks ]Change in ALT, as measured by a change in patients with ALT >= 30 U/L at baseline
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Ages Eligible for Study: | 40 Years to 79 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
- Adult, age ≥ 40 and < 80 years
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Participant must meet at least one of following sets of conditions:
- BMI ≥ 27 kg/m² OR
- 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% ⁶⁹.
- 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.
- 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.
- 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:
- 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
- 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
- VCTE ≥ 20 kPa
- Platelet count ≤ 140,000 per Ml
- Albumin < 3.6 g/dL
- INR > 1.35, unless on coumadin for another indication
- Serum creatinine > 2.0 mg/dL
- eGFR < 30 mL/min/1.73 m² as defined according to the CKDEPI creatinine equation⁷⁰
- Use of other weight loss medications, including GLP1RA within the last 90 days
- Greater than 10% weight loss in the prior six months
- Known or suspected hypersensitivity to GLP1RA medications including semaglutide
- History of bariatric surgery within the past 5 years or expected bariatric surgery
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Evidence of other causes of chronic liver disease including:
- Hepatitis B, as defined as presence of hepatitis B surface antigen (HBsAg).
- Previous or current infection with Hepatitis C, as defined by presence of hepatitis C virus Ab in serum (anti-HCV Ab).
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06005012
Contact: Egbert Madamba | (858) 246-2227 | emadamba@health.ucsd.edu |
United States, California | |
University of California, San Diego | Recruiting |
La Jolla, California, United States, 92093 | |
Contact: Egbert Madamba 858-246-2227 emadamba@health.ucsd.edu |
Principal Investigator: | Rohit Loomba | University of California, San Diego |
Responsible Party: | Rohit Loomba, Professor, University of California, San Diego |
ClinicalTrials.gov Identifier: | NCT06005012 |
Other Study ID Numbers: |
NRC-2023-1 |
First Posted: | August 22, 2023 Key Record Dates |
Last Update Posted: | September 7, 2023 |
Last Verified: | September 2023 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Non-alcoholic Fatty Liver Disease Semaglutide Liver Diseases Fatty Liver Liver Cirrhosis Diabetes Mellitus, Type 2 Fibrosis Pathologic Processes |
Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Digestive System Diseases Glucagon-Like Peptide-1 Receptor Agonists Hypoglycemic Agents Physiological Effects of Drugs |