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HomeTrials › NCT04822181

Liver (MASH) · Phase 3 · Active, not recruiting

Research Study on Whether Semaglutide Works in People With Non-alcoholic Steatohepatitis (NASH)

NCT04822181 · Sponsor: Novo Nordisk A/S

What this trial means for you

This study is active, not recruiting — it is not currently taking new participants, but its results may matter for treatments you're considering. It's studying Semaglutide, Placebo for non-alcoholic steatohepatitis.

Who can joinAll sexes, 18 Years and older
Healthy volunteersNo — diagnosis required
What you'd takeSemaglutide, Placebo
Study length~8.1 years overall
Planned participants1,205
TypeInterventional (you receive treatment)

What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study — ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.

The study, in the sponsor's words

Semaglutide is a medicine studied in patients with NASH. Semaglutide is a well-known medicine, which is already used by doctors to treat type 2 diabetes in many countries. Participants will either get semaglutide or a dummy medicine - which treatment participants get is decided by chance. Participants will need to inject themselves with medicine under the skin. Participants will need to do this once a week. The study will last for about 5 years. Participants will have up to 21 clinic visits and 9 phone calls with the clinical staff during the study. Some of the clinic visits may be spread over more than one day. Participants with other chronic liver diseases cannot take part in this study. Women cannot take part in the study if they are pregnant, breast-feeding or plan to become pregnant during the study period.

Can you join? The exact criteria

Below is the verbatim eligibility text from the registry — bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.

Full eligibility criteria (for you and your doctor)

Inclusion Criteria: * Age above or equal to 18 years at the time of signing informed consent. * Histological evidence of NASH based on a central pathologist evaluation of the baseline liver biopsy. The baseline liver biopsy can be a historical biopsy obtained within 180 days prior to the screening visit (V1). * Histological evidence of fibrosis stage 2 or stage 3 according to the NASH CRN (Clinical Research Network) classification based on a central pathologist evaluation of the baseline liver biopsy. * A histological NAS (Non-alcoholic fatty liver disease Activity Score) above or equal to 4 with a score of 1 or more in steatosis, lobular inflammation and hepatocyte ballooning based on a central pathologist evaluation of the baseline liver biopsy. Exclusion Criteria: * Documented causes of chronic liver disease other than non-alcoholic fatty liver disease (NAFLD) * Positive HBsAg, positive anti-HIV, positive HCV RNA at screening (V2A) or any known presence of HCV RNA or HBsAg within 2 years of screening (V2A). * Presence or history of ascites, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis or liver transplantation at randomisation. * Known or suspected excessive consumption of alcohol (greater than 20 g/day for women or greater than 30 g/day for men) or alcohol dependence (assessed by the Alcohol Use Disorders Identification Test (AUDIT questionnaire)). * Treatment with vitamin E (at doses greater than or equal to 800 IU/day) or pioglitazone or medications approved for treatment of NASH which has not been at a stable dose in the period from 90 days prior to the screening visit (V2A). In addition, for subjects with historical liver biopsies taken more than 90 days prior to screening, treatment should be at a stable dose from time of biopsy until screening. * Treatment with GLP-1 RAs in the period from 90 days prior to the screening visit (V2A). In addition, for subjects with historical liver biopsies taken more than 90 days prior to screening, any treatment with GLP-1 RAs from time of biopsy until screening (V2A). * Treatment with glucose-lowering agent(s) (other than GLP-1 RAs), lipid-lowering medication or weight loss medication not stable in the opinion of the investigator in the period from 90 days prior to the screening visit (V2A). In addition, for subjects with historical liver biopsies taken more than 90 days prior to screening, treatment should be at a stable dose in the opinion of the investigator from time of biopsy until screening.

Study sites by state

Alabama

  • North AL Health Res, LLC — Huntsville

Arizona

  • The Institute for Liver Health — Chandler
  • Inst-Liver Hlth dba AZ Liver H — Peoria
  • Inst. Liver H II dba AZ Liver H — Tucson
  • Del Sol Research Management, LLC — Tucson

Arkansas

  • ARcare Center for Clinical Research — Jonesboro
  • ARcare Center for Clinical Research — Little Rock
  • Arkansas Diagnostic Center, PA — Little Rock

California

  • Gastroenterology & Liver Institute — Escondido
  • Shang Wu M.D. Inc. — Hacienda Heights
  • Scripps Whittier Diabetes Inst — La Jolla
  • UCSD NAFLD Research Center — La Jolla
  • OM Research LLC — Lancaster
  • Digestive Hlth Res of SoCa — Long Beach
  • OM Research LLC — Oxnard
  • Cedars-Sinai Medical Center — Pasadena
  • Pasedena Liver Center — Pasadena
  • Inland Empire Clin Trials LLC — Rialto
  • UC Davis Hlth -Midtwn Ambu Cen — Sacramento
  • University of California, San Francisco — San Francisco
  • Silicon Valley Res Inst — San Jose

Colorado

  • Peak Gastro Assoc-Col Springs — Colorado Springs

Connecticut

  • Yale Ctr for Clin Invest — New Haven

Florida

  • Encore Medical Research of Boynton Beach LLC — Boynton Beach
  • Integrity Clinical Research, LLC — Doral
  • Covenant Metabolic Specialists, Ft. Myers — Fort Myers
  • University of Florida-CTRB — Gainesville
  • Miguel Rebollar PA — Hialeah
  • Direct Helpers Research Center — Hialeah
  • Florida Research Institute, LLC — Lakewood Rch
  • Sandhill Research, LLC — Maitland
  • Tandem Clinical Research - Maitland — Maitland
  • Optimus U, Corp — Miami
  • Univ of Miami/Schiff Ctr — Miami
  • Genoma Research Group, Inc — Miami
  • IMIC Inc — Miami
  • San Marcus Res Clin Miami Lakes — Miami Lakes
  • Ocala GI Research — Ocala
  • Sensible Healthcare LLC — Ocoee
  • Covenant Metabolic Specialists LLC — Sarasota
  • Headlands Research - Sarasota — Sarasota
  • Theia Clinical Research Centers LLC — St. Petersburg
  • ClinCloud, LLC — Viera E.
  • Florida Medical Clinic Orlando Health — Zephyrhills

Georgia

  • Emory University Hospital — Atlanta
  • Columbus Regional Research Institute — Columbus
  • Gastroenterology Assoc_ CGA — Macon
  • Gastroint Spec of Georgia — Marietta

Illinois

  • Rush University Med. Cntr — Chicago
  • University Of Chicago — Chicago
  • Endeavor Health — Skokie

Indiana

  • Indiana University Hospital — Indianapolis
  • Digestive Research Alliance of Michiana — South Bend

Iowa

  • Iowa Digestive Disease Center — Clive

Kansas

  • University Of Kansas Hospital — Kansas City
  • Kansas Medical Clinic, PA — Topeka

Louisiana

  • Tandem Clinical Research - Houma — Houma
  • Tandem Clinical Research — Marrero
  • Tandem Clinical Research - Metairie — Metairie
  • Louisiana Research Center, LLC — Shreveport

Maryland

  • Mercy Medical Center, GI Research — Baltimore
  • Walter Reed Nat Mil Md Ctr — Bethesda
  • Woodholme Gastroenterology Associates — Glen Burnie

Massachusetts

  • Boston Medical Center_Cary — Boston

Michigan

  • University of Michigan Medicine — Ann Arbor
  • Henry Ford Health System — Detroit

Minnesota

  • Mayo Clinic — Rochester

Mississippi

  • Southern Therapy and Advanced Research LLC — Jackson

Missouri

  • Clinical Research Professionals — Chesterfield
  • Kansas City Research Institute — Kansas City

Nebraska

  • Univ of Nebraska Medical CTR — Omaha

Nevada

  • Jubilee Clinical Research, Inc. — Las Vegas
  • Sierra Clinical Research-Las Vegas — Las Vegas

New Jersey

  • AIG Digestive Disease Research — Florham Park
  • Premier Health Research, LLC — Sparta

New York

  • NYU Grossman School of Med — New York
  • Weill Cornell Med Coll-NYPH — New York
  • Icahn Sch of Med-Mt Sinai Hosp — New York

North Carolina

  • AtriumHealth Liver Care, Pineville — Charlotte
  • Northeast GI Research Division — Concord
  • Duke Univ. Med CNTR_Durham_2 — Durham

Ohio

  • Ohio State Univ Wexner Med Ctr — Columbus
  • Objective GI — Springboro
  • CRIOH — Westlake

Oklahoma

  • Options Health Research, LLC — Tulsa

Pennsylvania

  • Geisinger Clinic — Danville
  • Pennsylvania State University — Hershey
  • Univ of Pennsylvania Hospital — Philadelphia
  • Thomas Jefferson University Hospital — Philadelphia
  • UPMC Center for Liver Diseases — Pittsburgh
  • UPMC_Center for Liver Care — Pittsburgh
  • Care Access Research, Pottsville — Pottsville

Rhode Island

  • Clinical Res Collaborative — Cumberland
  • Ocean St Clin Res Partnrs, LLC — Lincoln

South Carolina

  • Medical University Of South Carolina — Charleston

Tennessee

  • WR-ClinSearch, LLC — Chattanooga
  • Digestive Health Res-TSMC — Hermitage
  • East Tennessee Research Institute — Johnson City
  • Quality Medical Research — Nashville

Texas

  • Amarillo Center for Clinical Research, Ltd. — Amarillo
  • Texas Clin Res Inst, LLC — Arlington
  • Liver Ins@ Mthdist DTX Med Cen — Dallas
  • Velocity Clinical Res-Dallas — Dallas
  • UT Southwestern Med Cntr — Dallas
  • South Texas Research Institute — Edinburg
  • Brooke Army Medical Ctr. — Fort Sam Houston
  • GI Alliance Research — Fort Worth
  • Baylor College Of Medicine — Houston
  • Houston Methodist Hospital — Houston
  • Bipharma Informatic Inc. — Houston
  • Bylr Coll Md-Ben Taub Gen Hos — Houston
  • Houston Research Institute — Houston
  • Biopharma Informatic — Houston
  • Amir Ali Hassan, MD, PA — Houston
  • Centex Studies - McAllen — McAllen
  • LinQ Research, LLC — Pearland
  • Amer. Rrsch Corp-TX Liver Inst — San Antonio
  • Clinical Trials of Texas, LLC — San Antonio
  • Mt Olympus Medical Research, LLC — Sugar Land
  • Digestive Hlth Res of N Texas — Wichita Falls

Utah

  • South Ogden Family Medicine/ CCT Research — Ogden
  • Velocity Clinical Research, Riverton — Riverton
  • University of Utah — Salt Lake City

Virginia

  • University Of Virginia Hospital — Charlottesville
  • Inova Fairfax Medical Campus — Falls Church
  • Digestive and Liver Disease Specialists — Norfolk
  • Bon Secours Richmond Community Hospital LLC — Richmond
  • McGuire VA Medical Center — Richmond
  • VCU Health System — Richmond
  • Gastroent Consult of SW VA — Roanoke

View the official record on ClinicalTrials.gov →

Verify before you act. Medical disclaimer: content on this site is for informational purposes only and is not medical advice. GLP-1 medications are prescription drugs; always consult a licensed healthcare provider about eligibility, risks, and benefits. Trial details and enrollment status change frequently — always verify on the official registry and talk to your own clinician before contacting a study site. This page was generated from registry data and is not affiliated with the study sponsor.

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