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GLP-1 Receptor Agonist

Semaglutide for Non-alcoholic Fatty Liver Disease (SAMARA Trial)

Phase 2
Recruiting
Led By Rohit Loomba
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
BMI ≥ 27 kg/m² OR BMI ≥ 25 kg/m² AND presence of pre-diabetes (HbA1C ≥ 5.7) or 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) OR Fasting plasma glucose (FPG) ≥ 126 mg/dl (7.0 mmol/L) OR Plasma glucose ≥ 200 mg/dL (11.1 mmol/L) during a 75-g oral glucose tolerance test (OGTT)⁶⁸ OR Hemoglobin A1C (HbA1C) ≥ 6.5%
Must not have
Known or suspected hypersensitivity to GLP1RA medications including semaglutide
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 52 weeks

Summary

This trial tests if a drug can help treat advanced fatty liver disease in people with obesity or diabetes.

Who is the study for?
This trial is for adults aged 40-79 with obesity or type 2 diabetes, showing symptoms of diabetes and having a BMI ≥27 kg/m² (or ≥25 kg/m² with pre-diabetes). They must have liver fibrosis due to NAFLD but not severe cirrhosis or other chronic liver diseases. Participants should not be heavy alcohol users, on certain medications, or have had significant weight loss recently.
What is being tested?
The study aims to identify at-risk individuals for advanced NAFLD and assess the effectiveness of Semaglutide in treating significant fibrosis caused by NAFLD in these high-risk patients. It compares Semaglutide against a placebo in a real-world setting.
What are the potential side effects?
Semaglutide may cause digestive issues like nausea, vomiting, diarrhea; risk of low blood sugar; possible thyroid tumors; pancreatitis; changes in vision; kidney problems. Side effects vary among individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My BMI is over 27, or it's over 25 and I have pre-diabetes or type 2 diabetes.
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I have diabetes symptoms and high blood sugar levels.
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I am between 40 and 79 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am allergic or react badly to GLP1RA medications like semaglutide.
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I have cirrhosis, confirmed by a liver biopsy or symptoms like ascites.
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I have lost more than 10% of my weight in the last six months.
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I have had or am planning to have weight loss surgery within 5 years.
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I have not heavily consumed alcohol in the last 10 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~52 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in fibrosis due to NAFLD
Secondary study objectives
Change in ALT
Change in liver stiffness
Change in steatosis

Side effects data

From 2020 Phase 4 trial • 104 Patients • NCT04189848
21%
Nausea
12%
Decreased Appetite
100%
80%
60%
40%
20%
0%
Study treatment Arm
Overall Study

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SemaglutideExperimental Treatment1 Intervention
2.4 mg weekly for 52 weekly in a 3 ml PDS290 pen-injector containing Semaglutide 3.0 mg/ml for subcutaneous use
Group II: PlaceboPlacebo Group1 Intervention
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Semaglutide
2021
Completed Phase 4
~5160

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor
1,180 Previous Clinical Trials
1,574,936 Total Patients Enrolled
13 Trials studying Non-alcoholic Fatty Liver Disease
2,379 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Rohit LoombaPrincipal InvestigatorUniversity of California, San Diego
4 Previous Clinical Trials
773 Total Patients Enrolled
1 Trials studying Non-alcoholic Fatty Liver Disease
100 Patients Enrolled for Non-alcoholic Fatty Liver Disease
~19 spots leftby Mar 2025
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