A Study of a Thyroid Hormone Receptor Beta Isoform (THRβ) Agonist and an Semicarbazide Sensitive Amine Oxidase (SSAO) Inhibitor, Alone and in Combination, in Adults With Presumed Metabolic Dysfunction-associated Steatohepatitis (MASH)

Part of paid clinical trials in Chandler, Arizona.

Sponsor
Eccogene
Study ID
NCT07288138
Phase
PHASE2
Status
Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Placebo — DRUG
    Placebo will be administered as matching oral capsules.
  • ECC4703 — DRUG
    ECC4703 will be administered as oral capsules.
  • ECC0509 — DRUG
    ECC0509 will be administered as oral capsules.
  • ECC4703 — DRUG
    ECC4703 will be administered as oral capsules.

Study Details

The primary objective of this trial is to evaluate the dose-dependent and comparative effects of ECC4703 (low and high dose), ECC0509 (low and high dose), and their combination on hepatic fat reduction as assessed by change in magnetic resonance imaging proton density fat fraction (MRI-PDFF) at Week 12.

Key Dates

Start date
Dec 15, 2025
Status verified
Jun 2026
Primary completion
Sep 15, 2027
Completion
Sep 29, 2027

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
  • Experimental: ECC4703 Low Dose
  • Experimental: ECC4703 High Dose
  • Experimental: ECC4703 High Dose + ECC0509 High Dose
  • Experimental: ECC0509 Low Dose
  • Experimental: ECC0509 High Dose

Primary Outcome Measure

Relative Change from Baseline in Liver Fat Content by MRI-PDFF, Comparing ECC4703 Monotherapy Versus Placebo [ Time Frame: Baseline and Week 12 ]

Central Contacts

Locations (58)

FacilityCityStateZIPSite coordinators
Arizona Liver HealthChandlerArizona85224-
Arizona Liver Health - PeoriaPeoriaArizona85381-
Adobe Clinical Research, LLCTucsonArizona85712-
Arizona Liver Health - TucsonTucsonArizona85712-
ARcare Center for Clinical ResearchLittle RockArkansas77205-
Arkansas Gastroenterology, P.ALittle RockArkansas71913-
Om ResearchApple ValleyCalifornia92307-
ARK Clinical Research - Fountain ValleyFountain ValleyCalifornia92708-
Ark Clinical ResearchLong BeachCalifornia90815-
Knowledge Research CenterOrangeCalifornia92868-
Synergy HealthcareBradentonFlorida33511-
Synergy HealthcareBradentonFlorida34209-
Health Awareness, Inc.JupiterFlorida33458-
Evolution Clinical TrialsMiamiFlorida33122-
Floridian Clinical Research, LLCMiami LakesFlorida33016-
Ocala GI ResearchOcalaFlorida34471-
Progressive Medical ResearchPort OrangeFlorida32127-
ClinCloud, LLCVieraFlorida32940-
Metabolic Research InstituteWest Palm BeachFlorida33401-
CenExel - iResearchDecaturGeorgia30030-
Gastrointestinal Specialists of Georgia, PCMariettaGeorgia30060-
Digestive Research Alliance of MichianaSouth BendIndiana46635-
Tandem Clinical ResearchCovingtonLouisiana70433-
Tandem Clinical ResearchHoumaLouisiana70360-
Tandem Clinical Research GI, LLCMarreroLouisiana70072-
Tandem Clinical ResearchMetairieLouisiana70006-
Delta Research PartnersMonroeLouisiana71201-
Louisiana Research Center, LLCShreveportLouisiana71105-
Delta Research Partners, LLCWest MonroeLouisiana71291-
Mid-Atlantic GI ResearchGreenbeltMaryland20770-
Gastrointestinal AssociatesColumbiaMissouri65201-
Gateway GI Research, LLCSt LouisMissouri63141-
Jubilee Clinical Research, IncLas VegasNevada89106-
Premier Health ResearchSpartaNew Jersey07871-
Coastal Research InstituteFayettevilleNorth Carolina28304-
Akron Gastro ResearchAkronOhio44333-
Digestive SpecialistsDaytonOhio45414-
DSI ResearchSpringboroOhio45066-
Columbia Gastroenterology Associates, LlcColumbiaSouth Carolina29204-
Pinnacle Clinical ResearchAustinTexas78757-
Bellaire Clinical ResearchBellaireTexas77401-
South Texas Research Institute (STRI) - BrownsvilleBrownsvilleTexas78520-
Pinnacle Clinical ResearchCorpus ChristiTexas78404-
South Texas Research Institute (STRI)EdinburgTexas78539-
Dallas Research Institute, LLCFarmers BranchTexas75234-
Care United ResearchForneyTexas75126-
Evidentis Clinical ResearchFort WorthTexas76104-
Pinnacle Clinical Research - GeorgetownGeorgetownTexas78626-
Houston Research InstituteHoustonTexas77079-
Houston Research Institute - Medical CenterHoustonTexas770004-
Houston Research Institute - PasadenaPasadenaTexas77505-
Pinnacle Clinical ResearchSan AntonioTexas78229-
Pinnacle Clinical Research - South San AntonioSan AntonioTexas78222-
Quality Research, Inc.San AntonioTexas78209-
Sugarland Medical Associates (Sma)Sugar LandTexas77478-
Digestive Research of Central TexasWacoTexas76712-
Digestive Health Research of North Texas, LLCWichita FallsTexas76301-
GI Select Health ResearchRichmondVirginia23236-

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