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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%

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 52 weeks

Awards & highlights

SAMARA Trial 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.Check my eligibility

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.See study design

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.

SAMARA Trial 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.

SAMARA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 52 weeks

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in fibrosis due to NAFLD

Secondary outcome measures

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%

Study treatment Arm

Overall Study

SAMARA 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

2019

Completed Phase 4

~5160

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor

1,122 Previous Clinical Trials

1,520,924 Total Patients Enrolled

13 Trials studying Non-alcoholic Fatty Liver Disease

2,989 Patients Enrolled for Non-alcoholic Fatty Liver Disease

Rohit LoombaPrincipal InvestigatorUniversity of California, San Diego

4 Previous Clinical Trials

784 Total Patients Enrolled

1 Trials studying Non-alcoholic Fatty Liver Disease

100 Patients Enrolled for Non-alcoholic Fatty Liver Disease

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria must people meet to qualify for participation in this trial?

"To partake in this research study, individuals must have been diagnosed with liver fibrosis and be between 40 to 79 years old. As of now, the researchers are hoping to enrol 120 participants."

Answered by AI

Is this clinical research including participants aged 55 and above?

"This trial is restricted to patients between the ages of 40 and 79. By contrast, there are 137 trials for minors under 18 years old, as well as 1396 studies targeting elderly individuals over 65."

Answered by AI

Are individuals able to enroll in this experiment yet?

"Affirmative. Explicitly stated on clinicaltrials.gov, this trial is recruiting participants as of now. It was first published on July 25th 2023 and the latest update occurred September 1st 2023. The research necessitates 120 recruits at one site location."

Answered by AI

How many individuals have signed up for this research project?

"Affirmative. Per the information shared on clinicaltrials.gov, this medical trial is currently recruiting participants and was first published on July 25th 2023 with its last update occurring September 1st 2023. The study requires 120 people to be enrolled from a single site."

Answered by AI

Has Semaglutide been verified by the Food and Drug Administration?

"Semaglutide received a score of 2 on our scale due to the lack of evidence for efficacy, but there is some clinical data available that can help assess safety."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Rohit Loomba 2023. "Semaglutide Treatment in the Real-world for Fibrosis Due to NAFLD in Obesity and T2DM". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06005012.

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