Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 2interventionalRules rewrite

Phase 2: testing Placebo for Metabolic Dysfunction-associated Steatohepatitis

The primary objective of this trial is to measure 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.

Official registry: https://clinicaltrials.gov/study/NCT07288138 · Eccogene · enrollment listed as 160

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Placebo, ECC4703, or ECC0509. The registry lists allocation as randomized. The primary objective of this trial is to measure 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.

They plan to enroll about 160 people at 69 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Phase 2a, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of a THRβ Agonist (ECC4703), an SSAO Inhibitor (ECC0509), and Their Combination in Adults With Presumed MASH

Interventions: Placebo, ECC4703, ECC0509, ECC4703

Primary outcome (registry wording): Relative Change from Baseline in Liver Fat Content by MRI-PDFF, Comparing ECC4703 Monotherapy Versus Placebo

Who it is for (from inclusion criteria)

  • Ages 18 Years to 75 Years
  • Diagnosis of presumed MASH based on: liver biopsy within 180 days prior to screening showing an NAFLD activity score (NAS) of ≥3 and a fibrosis score (F) of F1-3 OR FibroScan® CAP \>280 dB/m at screening with presence of metabolic risk factors
  • Evidence of hepatic steatosis confirmed by FibroScan® LSM \> 7 kPa and \< 20 kPa and MRI-PDFF \>8% at screening
  • body-mass index (BMI) \>25 kg/m\^2 to \<50 kg/m\^2 (non-Asian); body-mass index (BMI) ≥23.0 to \<50.0 kg/m\^2 (Asian)
  • ALT ≥60 U/L at the first screening visit and stability of ALT and AST levels during the screening period
  • Estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73m\^2 (Chronic Kidney Disease Epidemiology Collaboration, \[CKD-EPI\])
  • Stable body weight (no \>5% change) for at least 6 months prior to screening
  • In the opinion of the investigator, able to participate safely and complete required MRI/biomarker assessments

Public study contact (from the registry)

Eccogene Clinical Trials

86-21-61053022

contact@eccogene.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

69 listed

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FAQ about this NCT record

Is NCT07288138 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07288138?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07288138?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary