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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 belowSelect...
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:Select...
I am HIV positive.
Select...
My thyroid condition is not under control.
Select...
I am currently taking orlistat.
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I have a severe form of diabetic eye disease.
Select...
I or my close family member have had medullary thyroid cancer or I have MEN-2.
Select...
I am not on medications like atypical neuroleptics, tetracycline, methotrexate, or tamoxifen.
Select...
My kidney function is reduced with a creatinine clearance below 60 ml/min.
Select...
I have advanced liver disease with significant symptoms or test results.
Select...
I am not pregnant, breastfeeding, and willing to use contraception during the study.
Select...
I have had weight loss surgery or part of my stomach removed and have problems digesting food.
Select...
My thyroid nodule has features that may suggest cancer, or my TSH levels are abnormal.
Select...
I cannot or do not want to receive shots under my skin.
Select...
I have been diagnosed with congestive heart failure.
Select...
I cannot have a liver biopsy due to health reasons.
Select...
I have a liver condition like autoimmune hepatitis or hemochromatosis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 hours after an oral 75g glucose load
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 hours after an oral 75g glucose load
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 • NCT0418984821%
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
2,464 Previous Clinical Trials
4,337,369 Total Patients Enrolled
57 Trials studying Non-alcoholic Fatty Liver Disease
10,138 Patients Enrolled for Non-alcoholic Fatty Liver Disease
National Cancer Institute (NCI)NIH
13,958 Previous Clinical Trials
41,112,496 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am HIV positive.My thyroid condition is not under control.I am currently taking orlistat.I have a severe form of diabetic eye disease.I or my close family member have had medullary thyroid cancer or I have MEN-2.I have a fatty liver with a fat content of 10% or more.I haven't used diabetes medications like insulin or metformin in the last 3 months.I am not on medications like atypical neuroleptics, tetracycline, methotrexate, or tamoxifen.My diabetes is controlled with an HbA1c of 9% or less and stable treatment for the last 3 months.My kidney function is reduced with a creatinine clearance below 60 ml/min.I have chronic hepatitis B or C, or I was successfully treated for hepatitis C over 18 months ago.I have heart disease but have been stable for over a year after treatment.You have struggled with drinking alcohol or using drugs in the past year.I have liver injury likely caused by medication, but my enzyme levels have been stable for 6 months.I have advanced liver disease with significant symptoms or test results.I have a blood clotting disorder or low platelet count but can stop my antiplatelet medication for a liver biopsy.You have a known or suspected allergy to the study medication, its ingredients, or similar products.I am not pregnant, breastfeeding, and willing to use contraception during the study.I have had weight loss surgery or part of my stomach removed and have problems digesting food.I haven't taken new NAFLD treatments in the last 3 months or have been on a stable dose for 6 months.You cannot have taken any experimental medication in the three months before joining this trial.My thyroid nodule has features that may suggest cancer, or my TSH levels are abnormal.I cannot or do not want to receive shots under my skin.You have eating disorders like anorexia or bulimia that are not under control.I am 18 years old or older.I have been diagnosed with fatty liver disease through a biopsy or imaging in the last year.I have been diagnosed with congestive heart failure.I cannot have a liver biopsy due to health reasons.You drink less than 30 grams of alcohol per day if you're a man, or less than 20 grams per day if you're a woman. You also don't engage in binge-drinking.I have a liver condition like autoimmune hepatitis or hemochromatosis.
Research Study Groups:
This trial has the following groups:- Group 1: Arm C: Healthy
- Group 2: Arm A: Steatosis
- Group 3: Arm B: NASH
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.