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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 hours after an oral 75g glucose load
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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
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
2019
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
2,359 Previous Clinical Trials
4,315,411 Total Patients Enrolled
46 Trials studying Non-alcoholic Fatty Liver Disease
9,888 Patients Enrolled for Non-alcoholic Fatty Liver Disease
National Cancer Institute (NCI)NIH
13,662 Previous Clinical Trials
40,925,797 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies for individuals to participate in this research?
"Affirmative, according to clinicaltrials.gov this trial is currently recruiting individuals. Established on July 24th 2019 and most recently revised November 10th 2022, the study requires 84 people at a single center."
Answered by AI
Has this trial been previously conducted elsewhere?
"At this time, 58 studies evaluating semaglutide are occurring in 55 nations spanning 772 cities. The first trial was initiated by Novo Nordisk A/S and completed Phase 4 approval in 2018 with a cohort of 1387 individuals; since then, 124 further investigations have been conducted."
Answered by AI
Could you please furnish an overview of prior research regarding Semaglutide?
"Currently, there are 27 Phase 3 trials and 31 other Semaglutide studies being conducted. The majority of the sites for these clinical experiments are found in Loma Linda, California but a total of 3907 locations throughout America have been recruited to work on this research endeavour."
Answered by AI
What medical ailments does semaglutide typically address?
"Semaglutide is a viable treatment option for those struggling with chronic weight management, seeking to reduce their caloric intake and become more physically active."
Answered by AI
What is the upper limit of participants for this clinical trial?
"Yes, the data available on clinicaltrials.gov confirms that this medical trial is actively seeking participants after its initial posting in July 2019 and last update of November 2022. The experiment requires 84 volunteers to be recruited from a single site."
Answered by AI
Is Semaglutide an effective and secure treatment for individuals?
"The safety of semaglutide is rated a 2 due to the fact that it has only entered Phase 2 clinical trials, indicating there is some data describing its security profile but none demonstrating efficacy."
Answered by AI
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