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

Part of paid clinical trials in Chandler, Arizona.

Sponsor
Gilead Sciences
Study ID
NCT03987074
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Semaglutide — DRUG
    Solution administered subcutaneously with pre-filled PDS290 pen-injector once weekly
  • Firsocostat — DRUG
    Tablets administered orally once daily
  • Cilofexor — DRUG
    Tablets administered orally once daily

Study Details

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

Key Dates

Start date
Jul 29, 2019
Status verified
Jun 2021
Primary completion
Jul 13, 2020
Completion
Jul 13, 2020

Study Design

Enrollment
109 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Semaglutide
    Semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) for 24 weeks
  • Experimental: Semaglutide + Firsocostat 20 mg
    Semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) + firsocostat 20 mg for 24 weeks
  • Experimental: Semaglutide + Cilofexor 30 mg
    Semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) + cilofexor 30 mg for 24 weeks
  • Experimental: Semaglutide + Cilofexor 100 mg
    Semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) + cilofexor 100 mg for 24 weeks
  • Experimental: Semaglutide + Firsocostat 20 mg + Cilofexor 30 mg
    Semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) + firsocostat 20 mg + cilofexor 30 mg for 24 weeks

Primary Outcome Measure

Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: First dose date up to Week 24 plus 30 days ]

Locations (18)

FacilityCityStateZIPSite coordinators
Institute for Liver Health - Arizona Liver HealthChandlerArizona85224-
Southern California Research CentersCoronadoCalifornia92118-
University of California San Diego (UCSD)La JollaCalifornia92093-
Cedars Sinai Medical CenterLos AngelesCalifornia90048-
Ruane Clinical Research Group, IncLos AngelesCalifornia90036-
Inland Empire Clinical Trials, LLCRialtoCalifornia92377-
Medical Associates Research GroupSan DiegoCalifornia92123-
Gastrointestinal Specialists of GeorgiaMariettaGeorgia30060-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Jubilee Clinical Research, Inc.Las VegasNevada89109-
Northwell HealthManhassetNew York11030-
Gastro OneHuntersvilleNorth Carolina28078-
University GastroenterologyProvidenceRhode Island02905-
Gastro OneGermantownTennessee38138-
Quality Medical Research, PLLCNashvilleTennessee37211-
Texas Clinical Research InstituteArlingtonTexas76012-
The Liver Institute at Methodist Dallas Medical CenterDallasTexas75203-
American Research CorporationSan AntonioTexas78215-

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By research site
Institute for Liver Health - Arizona Liver Health· Chandler, AZSouthern California Research Centers· Coronado, CAUniversity of California San Diego (UCSD)· La Jolla, CACedars Sinai Medical Center· Los Angeles, CARuane Clinical Research Group, Inc· Los Angeles, CAInland Empire Clinical Trials, LLC· Rialto, CA

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