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Safety, Tolerability, and Efficacy of Monotherapy and Combination Regimens in Adults With Nonalcoholic Steatohepatitis (NASH)

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ClinicalTrials.gov Identifier: NCT03987074
Recruitment Status : Recruiting
First Posted : June 14, 2019
Last Update Posted : October 15, 2019
Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:
The primary objective of this study is to evaluate the safety and tolerability of study drug(s) in adults with nonalcoholic steatohepatitis (NASH).

Condition or disease Intervention/treatment Phase
Nonalcoholic Steatohepatitis Drug: Semaglutide Drug: Firsocostat Drug: Cilofexor Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Proof of Concept, Open-Label Study Evaluating the Safety, Tolerability, and Efficacy of Monotherapy and Combination Regimens in Subjects With Nonalcoholic Steatohepatitis (NASH)
Actual Study Start Date : July 29, 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : July 2020


Arm Intervention/treatment
Experimental: Semaglutide
Semaglutide 0.24 mg - 2.4 mg (dose escalation every 4 weeks) for 24 weeks
Drug: Semaglutide
Solution for injection administered subcutaneously once weekly

Experimental: Semaglutide + Firsocostat
Semaglutide 0.24 mg - 2.4 mg (dose escalation every 4 weeks) + firsocostat 20 mg for 24 weeks
Drug: Semaglutide
Solution for injection administered subcutaneously once weekly

Drug: Firsocostat
Tablets administered orally once daily
Other Name: GS-0976

Experimental: Semaglutide + Cilofexor 30 mg
Semaglutide 0.24 mg - 2.4 mg (dose escalation every 4 weeks) + cilofexor 30 mg for 24 weeks
Drug: Semaglutide
Solution for injection administered subcutaneously once weekly

Drug: Cilofexor
Tablets administered orally once daily
Other Name: GS-9674

Experimental: Semaglutide + Cilofexor 100 mg
Semaglutide 0.24 mg - 2.4 mg (dose escalation every 4 weeks) + cilofexor 100 mg for 24 weeks
Drug: Semaglutide
Solution for injection administered subcutaneously once weekly

Drug: Cilofexor
Tablets administered orally once daily
Other Name: GS-9674

Experimental: Semaglutide + Firsocostat + Cilofexor
Semaglutide 0.24 mg - 2.4 mg (dose escalation every 4 weeks) + firsocostat 20 mg + cilofexor 30 mg for 24 weeks
Drug: Semaglutide
Solution for injection administered subcutaneously once weekly

Drug: Firsocostat
Tablets administered orally once daily
Other Name: GS-0976

Drug: Cilofexor
Tablets administered orally once daily
Other Name: GS-9674




Primary Outcome Measures :
  1. Number of Participants Who Experience Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs), and Any Grade ≥ 1 Laboratory Abnormality [ Time Frame: First dose date up to Week 24 plus 30 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Historical liver biopsy consistent with NASH with stage 2-3 fibrosis according to NASH Clinical Research Network (CRN) classification OR clinical diagnosis of nonalcoholic fatty liver disease and screening FibroTest, magnetic resonance imaging - proton density fat fraction (MRI-PDFF), and FibroScan
  • Screening laboratory parameters, as determined by central laboratory:

    • Alanine aminotransferase (ALT) ≤ 5 x upper limit of the normal range (ULN)
    • Estimated glomerular filtration rate (eGFR) ≥ 30 milliliter/minute (mL/min), as calculated by the Modification of Diet in Renal Disease (MDRD) study equation
    • HbA1c ≤ 9.5%
    • International normalized ratio (INR) ≤ 1.2, unless due to therapeutic anti-coagulation therapy
    • Platelet count ≥ 100,000/μL
    • Total bilirubin < 1.3 x ULN unless alternate etiology such as Gilbert's syndrome present
    • Calcitonin ≤ 100 ng/L
  • Body Mass Index (BMI) > 23 kg/m^2 and body weight of > 60 kg

Key Exclusion Criteria:

  • Any historical liver biopsy consistent with cirrhosis
  • Any history of decompensated liver disease, including ascites, hepatic encephalopathy, or variceal bleeding
  • Other causes of liver disease, including but not limited to: alcoholic liver disease, hepatitis B, hepatitis C, autoimmune disorders (eg, primary biliary cholangitis (PBC), primary sclerosing cholangitis (PSC), autoimmune hepatitis), drug-induced hepatotoxicity, Wilson disease, clinically significant iron overload, or alpha-1-antitrypsin deficiency requiring treatment
  • History of liver transplantation
  • History of hepatocellular carcinoma
  • History of pancreatitis (acute or chronic)
  • Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma
  • Treatment with glucagon-like peptide-1 receptor agonists (GLP-1 RA) in the period from 90 days prior to the date of the Screening Visit
  • Individuals on antidiabetic medications must be on a stable dose for at least 90 days prior to the date of the Screening Visit and in the period between the date of the Screening Visit and Enrollment (Day -14)

Note: Other protocol defined Inclusion/Exclusion criteria may apply.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03987074


Contacts
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Contact: Gilead Clinical Study Information Center 1-833-445-3230 (GILEAD-0) GileadClinicalTrials@gilead.com

Locations
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United States, Arizona
Institute for Liver Health - Arizona Liver Health Recruiting
Chandler, Arizona, United States, 85224
United States, California
Southern California Research Centers Recruiting
Coronado, California, United States, 92118
Ruane Clinical Research Group, Inc Recruiting
Los Angeles, California, United States, 90036
Cedars Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Inland Empire Clinical Trials, LLC Recruiting
Rialto, California, United States, 92377
Medical Associates Research Group Recruiting
San Diego, California, United States, 92123
United States, Florida
Schiff Center for Liver Diseases - University of Miami Recruiting
Miami, Florida, United States, 33136
United States, Georgia
Gastrointestinal Specialists of Georgia Recruiting
Marietta, Georgia, United States, 30060
United States, Maryland
Mercy Medical Center Recruiting
Baltimore, Maryland, United States, 21202
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
United States, Nevada
Jubilee Clinical Research, Inc. Recruiting
Las Vegas, Nevada, United States, 89109
United States, New York
Northwell Health Recruiting
Manhasset, New York, United States, 11030
United States, Rhode Island
University Gastroenterology Recruiting
Providence, Rhode Island, United States, 02905
United States, Tennessee
Gastro One Recruiting
Germantown, Tennessee, United States, 38138
Quality Medical Research, PLLC Recruiting
Nashville, Tennessee, United States, 37211
United States, Texas
Texas Clinical Research Institute Recruiting
Arlington, Texas, United States, 76012
The Liver Institute at Methodist Dallas Medical Center Recruiting
Dallas, Texas, United States, 75203
American Research Corporation Recruiting
San Antonio, Texas, United States, 78215
United States, Virginia
Liver Institute of Virginia Recruiting
Richmond, Virginia, United States, 23226
Sponsors and Collaborators
Gilead Sciences
Novo Nordisk A/S
Investigators
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Study Director: Gilead Study Director Gilead Sciences

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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT03987074     History of Changes
Other Study ID Numbers: GS-US-454-5533
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases