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GLP-1 Receptor Agonist

Semaglutide for Non-Alcoholic Fatty Liver Disease

Phase 2
Recruiting
Led By Yaron Rotman, M.D.
Research Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Presence of NAFLD (steatosis grade greater than or equal to 1 on NASH-CRN scoring scale) on initial admission liver biopsy AND Liver fat content greater than or equal to 10% by 1H-MRS on initial admission
Be older than 18 years old
Must not have
HIV infection
Uncontrolled hypo- or hyperthyroidism
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 hours after an oral 75g glucose load
Awards & highlights
No Placebo-Only Group

Summary

This trial is studying how the liver in people with non-alcoholic fatty liver disease (NAFLD) responds to feeding, and how this relates to their response to the drug semaglutide.

Who is the study for?
Adults aged 18+ with Non-Alcoholic Fatty Liver Disease (NAFLD) can join this trial. They must have a certain level of liver fat and no recent significant alcohol consumption. Exclusions include pregnancy, breastfeeding, other liver diseases, uncontrolled diabetes or thyroid issues, severe kidney disease, specific medication use within the last 3 months, and inability to undergo MRI or biopsy.
What is being tested?
The trial is testing how Semaglutide affects the liver's response to sugar in people with NAFLD. Participants will undergo tests including blood work and imaging before and after receiving Semaglutide injections for up to 24 weeks at home followed by additional clinic visits.
What are the potential side effects?
While not explicitly listed in the provided information, common side effects of Semaglutide may include gastrointestinal symptoms like nausea or diarrhea, potential low blood sugar levels if diabetic, injection site reactions and possibly increased heart rate.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a fatty liver with a fat content of 10% or more.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am HIV positive.
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My thyroid condition is not under control.
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I am currently taking orlistat.
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I have a severe form of diabetic eye disease.
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I or my close family member have had medullary thyroid cancer or I have MEN-2.
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I am not on medications like atypical neuroleptics, tetracycline, methotrexate, or tamoxifen.
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My kidney function is reduced with a creatinine clearance below 60 ml/min.
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I have advanced liver disease with significant symptoms or test results.
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I am not pregnant, breastfeeding, and willing to use contraception during the study.
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I have had weight loss surgery or part of my stomach removed and have problems digesting food.
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My thyroid nodule has features that may suggest cancer, or my TSH levels are abnormal.
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I cannot or do not want to receive shots under my skin.
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I have been diagnosed with congestive heart failure.
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I cannot have a liver biopsy due to health reasons.
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I have a liver condition like autoimmune hepatitis or hemochromatosis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 hours after an oral 75g glucose load
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 hours after an oral 75g glucose load 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 hepatic gene expression
Clinical Improvement
Histological Improvement

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Arm B: NASHExperimental Treatment1 Intervention
Participants with NASH on baseline biopsy
Group II: Arm A: SteatosisExperimental Treatment1 Intervention
Participants with steatosis on baseline biopsy
Group III: Arm C: HealthyActive Control1 Intervention
Healthy Volunteers
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?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Lead Sponsor
2,449 Previous Clinical Trials
4,332,383 Total Patients Enrolled
56 Trials studying Non-alcoholic Fatty Liver Disease
10,088 Patients Enrolled for Non-alcoholic Fatty Liver Disease
National Cancer Institute (NCI)NIH
13,928 Previous Clinical Trials
41,018,055 Total Patients Enrolled
4 Trials studying Non-alcoholic Fatty Liver Disease
1,311 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Yaron Rotman, M.D.Principal InvestigatorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
6 Previous Clinical Trials
312 Total Patients Enrolled
3 Trials studying Non-alcoholic Fatty Liver Disease
149 Patients Enrolled for Non-alcoholic Fatty Liver Disease

Media Library

Semaglutide (GLP-1 Receptor Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT03884075 — Phase 2
Non-alcoholic Fatty Liver Disease Research Study Groups: Arm C: Healthy, Arm A: Steatosis, Arm B: NASH
Non-alcoholic Fatty Liver Disease Clinical Trial 2023: Semaglutide Highlights & Side Effects. Trial Name: NCT03884075 — Phase 2
Semaglutide (GLP-1 Receptor Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03884075 — Phase 2
~21 spots leftby Aug 2026
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