Non-Alcoholic Steatohepatitis study: Semaglutide
Official title Non-Alcoholic Fatty Liver Disease, the HEpatic Response to Oral Glucose, and the Effect of Semaglutide (NAFLD HEROES)
ClinicalTrials.gov ID: NCT03884075
What this study is testing
What is Semaglutide?
An investigational once‑weekly injectable medicine being studied for non‑alcoholic steatohepatitis (NASH). It is designed to mimic a hormone that helps regulate blood sugar and appetite.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to learn how the liver in people with NAFLD responds to eating and whether the drug semaglutide changes that response.
- Who it's for
- Adults 18 or older who have non‑alcoholic fatty liver disease or are healthy volunteers.
- What's involved
- Participants will have medical checks, blood and urine tests, imaging, and for NAFLD patients a liver biopsy. They will receive weekly injections of semaglutide at home and attend clinic visits for blood tests and repeat imaging.
- Time commitment
- The study lasts about 30 weeks of treatment plus follow‑up, with clinic visits at baseline, 6 weeks, 30 weeks, and a final visit 12 weeks after stopping treatment. Healthy volunteers finish after the baseline visit.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100. Healthy volunteers may be eligible.
You may be able to join if
- 1. Male or female Aged \>= 18 years of age.
- Histological evidence of hepatic steatosis on a liver biopsy within 12 months OR evidence of fatty liver disease, as documented by imaging...
- Estimated average alcohol consumption \< 30 g/d for men or \< 20 g/d for women in the 6 months prior to enrollment and no binge-drinking behavior.
- Ability of subject to understand and the willingness to sign a written informed consent document. Additional for Treatment Phase
- Presence of NAFLD (steatosis grade greater than or equal to 1 on NASH-CRN scoring scale) on baseline admission liver biopsy.
You likely can't join if
- Pregnant or breast-feeding
- Chronic infection with hepatitis C virus (HCV) or hepatitis B virus (HBV).
- HIV infection.
- Concomitant liver disease such as autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, Wilson s disease, alpha-1...
- Presence of definite or probable drug-induced liver injury. In the case of lipid-lowering, anti-hypertensive or anti-diabetic medications that are...
- Decompensated advanced liver disease, defined as direct bilirubin \> 0.5 g/dL, PT \> 18 , albumin \ 12 (applicable only in patients without Gilbert s...
See the full eligibility criteria
- 1. Male or female Aged \>= 18 years of age.
- Histological evidence of hepatic steatosis on a liver biopsy within 12 months OR evidence of fatty liver disease, as documented by imaging (ultrasound, CT, MRI, MRI-PDFF, MR spectroscopy, or Fibroscan CAP \>= 285...
- Estimated average alcohol consumption \< 30 g/d for men or \< 20 g/d for women in the 6 months prior to enrollment and no binge-drinking behavior.
- Ability of subject to understand and the willingness to sign a written informed consent document. Additional for Treatment Phase
- Presence of NAFLD (steatosis grade greater than or equal to 1 on NASH-CRN scoring scale) on baseline admission liver biopsy.
- Liver fat content greater than or equal to 10% by 1H-MRS on initial admission.
- Pregnant or breast-feeding
- Chronic infection with hepatitis C virus (HCV) or hepatitis B virus (HBV). Patients who were treated successfully for HCV and achieved sustained virological response can be eligible for enrollment \> 18 months after...
- HIV infection.
- Concomitant liver disease such as autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, Wilson s disease, alpha-1 antitrypsin deficiency, hereditary hemochromatosis.
- Presence of definite or probable drug-induced liver injury. In the case of lipid-lowering, anti-hypertensive or anti-diabetic medications that are suspected to cause aminotransferase elevation, patients will be eligible...
- Decompensated advanced liver disease, defined as direct bilirubin \> 0.5 g/dL, PT \> 18 , albumin \ 12 (applicable only in patients without Gilbert s syndrome), or history of ascites, encephalopathy, variceal bleeding...
- Treatment with medications known to cause fatty liver disease such as atypical neuroleptics, tetracycline, methotrexate or tamoxifen
- Uncontrolled hypo- or hyperthyroidism.
- Thyroid nodules with ultrasonographic features suggestive of an increased risk of thyroid cancer per radiologist reporting (hypoechoic, microcalcifications, twinkling on B flow imaging, central vascularity, irregular...
- Active coronary artery disease, defined as persistent angina pectoris, reversible ischemia on cardiac stress test or imaging, or the presence of significant coronary artery disease on imaging or catheterization.
- Congestive heart failure.
- Chronic kidney disease, with creatinine clearance \< 60 ml/min or eGFR \< 60/ml/min/m(2).
- Uncontrolled diabetes mellitus with HbA1c \> 9% will exclude people. Patients with diabetes may be enrolled only if they have HbA1c \<=9%, have been on stable therapy with lifestyle and/or metformin for at least 3...
- Use of insulin, sulfonylurea agents, thiazolidinediones, SGLT2 inhibitors, GLP-1 receptor agonists or DPP-4 inhibitors unless discontinued greater than or equal to 3 months before enrollment.
- Contraindication or inability to perform a liver biopsy.
- Patients with coagulopathy (PT/PTT values that are prolonged greater than or equal to 3 seconds from the upper limit of the normal, including treatment with oral and parenteral anticoagulants), thrombocytopenia (\<...
- Hemoglobin level \< 11 g/dL
- Contraindications to MRI (heart pacemakers, unless MRI safe, insulin pumps, implanted hearing aids, neurostimulators, intracranial metal clips, metallic bodies in the eye, metal hip replacements, sutures, extreme...
- History of gastric bypass or other bariatric surgery, partial or complete gastrectomy and known maldigestion or malabsorption.
- Treatment with orlistat.
- Patients with uncontrolled eating disorders including anorexia and bulimia nervosa.
- Patients with proliferative diabetic retinopathy.
- Use of medications or supplements to treat NAFLD (approved or unapproved) unless withdrawn greater than or equal to 3 months prior to enrollment or taken at a stable dose for greater than or equal to 6 months.
- Patients who had a liver biopsy performed less than or equal to 2 years before enrollment, unless they are willing to undergo all of the trial biopsies, knowing that these biopsies are purely for research and are not...
- Inability or unwillingness to receive subcutaneous injections.
- Known or suspected allergy to trial medication(s), excipients, or related products.
- Alcohol or substance abuse within the past 12 months.
- For women of childbearing potential, breast-feeding, pregnancy or inability or unwillingness to practice contraception for the duration of the study.
- Personal or first-degree family member with history of medullary thyroid carcinoma or people with known multiple endocrine neoplasia syndrome type 2 (MEN-2).
- Actively pursuing an intensive weight loss regiment, aimed at losing \> 10% of current body weight, by following a different diet or exercise regimen over the study time period or recent (\ 10%).
- The receipt of any investigational drug within 3 months prior to enrollment in this trial.
- Assessment by the principal investigator that the subject will be unlikely to complete the study procedures, or that enrollment puts the subject at a significant risk unspecified by the criteria above.
- Male or female Aged greater than or equal to 18 years of age.
- No evidence of hepatic steatosis by imaging or histology.
- No history of known liver disease.
- Individuals on regular systemic medications may be considered eligible, and their eligibility will be determined by the principal investigator.
- BMI less than or equal to 25 kg/m2
- Non-diabetic.
- Normal transaminases (ALT less than or equal to 31 U/L for men or less than or equal to 19 U/L for women, and AST less than or equal to 30 U/L).
- Fasting glucose less than or equal to 95 mg/dL.
- Ability of subject to understand and the willingness to sign a written informed consent document. EXCLUSION CRITERIA for Healthy Volunteers (arm C)
- Pregnant or breastfeeding
- Excessive alcohol consumption, defined as an average alcohol consumption over \> 1 drink per day over the past month
- Assessment by the principal investigator that the subject is unsuitable for participation in the study or that enrollment puts the subject at significant risk.
The study team makes the final eligibility decision.
Where it is enrolling
- Bethesda, Maryland, United States
Compensation & support
A stipend or payment for your time may be offered.
No amount is published here because ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team, so confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 100 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Bethesda, Maryland, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.