Actively Recruiting
A Phase 2a, Randomized, Double-blind, Placebo-controlled Study of ECC4703, ECC0509, and Their Combination in Adults With Presumed Metabolic Dysfunction-associated Steatohepatitis (MASH)
Led by Eccogene · Updated on 2026-06-05
160
Participants Needed
58
Research Sites
2 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of two drugs, ECC4703 and ECC0509, alone and in combination, on reducing liver fat in adults with presumed Metabolic Dysfunction-associated Steatohepatitis (MASH). This Phase 2a, randomized, double-blind, placebo-controlled study aims to understand how different doses impact liver fat as measured by MRI proton density fat fraction (MRI-PDFF) at 12 weeks. Participants will be randomly assigned to one of six groups: placebo, low or high dose ECC4703, low or high dose ECC0509, or a combination of high doses of both drugs. All treatments are given as oral capsules. The main treatment period lasts 12 weeks, during which the impact on liver fat and other related health markers will be assessed. During the study, participants will undergo various assessments including MRI scans to measure liver fat, blood tests to monitor liver enzymes and metabolic markers, and other biomarker evaluations at baseline and Week 12. Safety and drug levels will be monitored throughout. The study involves close follow-up to track changes in liver fat content and related health outcomes over the 12-week treatment period.
CONDITIONS
Brief Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults between 18 and 75 years of age who can provide informed consent and follow study procedures
- Diagnosis of presumed MASH based on liver biopsy within 180 days showing NAFLD activity score of 3 or more and fibrosis score F1-3, or FibroScan CAP over 280 dB/m with metabolic risk factors
- Evidence of hepatic steatosis with FibroScan liver stiffness measurement over 7 kPa and under 20 kPa and MRI-PDFF over 8% at screening
- Body mass index over 25 kg/m² to under 50 kg/m² (non-Asian); or over 23.0 to under 50.0 kg/m² (Asian)
- Alanine aminotransferase (ALT) 60 U/L or higher at first screening visit with stable ALT and AST during screening
- Estimated glomerular filtration rate (eGFR) 60 mL/min/1.73m² or higher
- Stable body weight (no more than 5% change) for at least 6 months before screening
- Willingness to comply with contraception requirements if applicable
- Ability to safely participate and complete MRI and biomarker assessments as judged by investigator
You will not qualify if you...
- Chronic liver diseases other than MASLD/MASH, including alcoholic liver disease, autoimmune hepatitis, cholestatic disease, genetic liver diseases, or drug-induced liver injury
- Presence of cirrhosis or portal hypertension based on liver histology or imaging
- ALT and/or AST greater than 5 times the upper limit of normal or alkaline phosphatase (ALP) over 2 times upper limit at screening
- Significant thyroid or adrenal dysfunction, including uncontrolled hypo- or hyperthyroidism or adrenal disorders
- Type 1 diabetes, HbA1c over 9.5%, or unstable type 2 diabetes with medication changes within 90 days
- Use of medications affecting liver fat or fibrosis within specified washout periods
- Significant alcohol use within 1 year prior to screening
- Recent cardiovascular events such as heart attack, stroke, unstable angina, severe heart failure, or uncontrolled arrhythmia
- Current or recent serious psychiatric illness including psychosis or active suicidal ideation within 5 years
- Pregnancy, breastfeeding, MRI contraindications, or other safety concerns preventing study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive oral capsules of ECC4703, ECC0509, their combination, or placebo to evaluate effects on liver fat content and other health measures.
Visits on Day 1, and Weeks 2, 4, 6, 8, and 12 for assessments and dosing
Trial Site Locations
Total: 58 locations
1
Arizona Liver Health
Chandler, Arizona, United States, 85224
Actively Recruiting
2
Arizona Liver Health - Peoria
Peoria, Arizona, United States, 85381
Actively Recruiting
3
Adobe Clinical Research, LLC
Tucson, Arizona, United States, 85712
Actively Recruiting
4
Arizona Liver Health - Tucson
Tucson, Arizona, United States, 85712
Actively Recruiting
5
Arkansas Gastroenterology, P.A
Little Rock, Arkansas, United States, 71913
Actively Recruiting
6
ARcare Center for Clinical Research
Little Rock, Arkansas, United States, 77205
Actively Recruiting
7
Om Research
Apple Valley, California, United States, 92307
Actively Recruiting
8
ARK Clinical Research - Fountain Valley
Fountain Valley, California, United States, 92708
Actively Recruiting
9
Ark Clinical Research
Long Beach, California, United States, 90815
Actively Recruiting
10
Knowledge Research Center
Orange, California, United States, 92868
Actively Recruiting
11
Synergy Healthcare
Bradenton, Florida, United States, 33511
Actively Recruiting
12
Synergy Healthcare
Bradenton, Florida, United States, 34209
Actively Recruiting
13
Health Awareness, Inc.
Jupiter, Florida, United States, 33458
Actively Recruiting
14
Evolution Clinical Trials
Miami, Florida, United States, 33122
Actively Recruiting
15
Floridian Clinical Research, LLC
Miami Lakes, Florida, United States, 33016
Actively Recruiting
16
Ocala GI Research
Ocala, Florida, United States, 34471
Actively Recruiting
17
Progressive Medical Research
Port Orange, Florida, United States, 32127
Actively Recruiting
18
ClinCloud, LLC
Viera, Florida, United States, 32940
Actively Recruiting
19
Metabolic Research Institute
West Palm Beach, Florida, United States, 33401
Actively Recruiting
20
CenExel - iResearch
Decatur, Georgia, United States, 30030
Actively Recruiting
21
Gastrointestinal Specialists of Georgia, PC
Marietta, Georgia, United States, 30060
Actively Recruiting
22
Digestive Research Alliance of Michiana
South Bend, Indiana, United States, 46635
Actively Recruiting
23
Tandem Clinical Research
Covington, Louisiana, United States, 70433
Actively Recruiting
24
Tandem Clinical Research
Houma, Louisiana, United States, 70360
Actively Recruiting
25
Tandem Clinical Research GI, LLC
Marrero, Louisiana, United States, 70072
Actively Recruiting
26
Tandem Clinical Research
Metairie, Louisiana, United States, 70006
Actively Recruiting
27
Delta Research Partners
Monroe, Louisiana, United States, 71201
Actively Recruiting
28
Louisiana Research Center, LLC
Shreveport, Louisiana, United States, 71105
Actively Recruiting
29
Delta Research Partners, LLC
West Monroe, Louisiana, United States, 71291
Actively Recruiting
30
Mid-Atlantic GI Research
Greenbelt, Maryland, United States, 20770
Actively Recruiting
31
Gastrointestinal Associates
Columbia, Missouri, United States, 65201
Actively Recruiting
32
Gateway GI Research, LLC
St Louis, Missouri, United States, 63141
Actively Recruiting
33
Jubilee Clinical Research, Inc
Las Vegas, Nevada, United States, 89106
Actively Recruiting
34
Premier Health Research
Sparta, New Jersey, United States, 07871
Actively Recruiting
35
Coastal Research Institute
Fayetteville, North Carolina, United States, 28304
Actively Recruiting
36
Akron Gastro Research
Akron, Ohio, United States, 44333
Actively Recruiting
37
Digestive Specialists
Dayton, Ohio, United States, 45414
Actively Recruiting
38
DSI Research
Springboro, Ohio, United States, 45066
Actively Recruiting
39
Columbia Gastroenterology Associates, Llc
Columbia, South Carolina, United States, 29204
Actively Recruiting
40
Pinnacle Clinical Research
Austin, Texas, United States, 78757
Actively Recruiting
41
Bellaire Clinical Research
Bellaire, Texas, United States, 77401
Actively Recruiting
42
South Texas Research Institute (STRI) - Brownsville
Brownsville, Texas, United States, 78520
Actively Recruiting
43
Pinnacle Clinical Research
Corpus Christi, Texas, United States, 78404
Actively Recruiting
44
South Texas Research Institute (STRI)
Edinburg, Texas, United States, 78539
Actively Recruiting
45
Dallas Research Institute, LLC
Farmers Branch, Texas, United States, 75234
Actively Recruiting
46
Care United Research
Forney, Texas, United States, 75126
Actively Recruiting
47
Evidentis Clinical Research
Fort Worth, Texas, United States, 76104
Actively Recruiting
48
Pinnacle Clinical Research - Georgetown
Georgetown, Texas, United States, 78626
Actively Recruiting
49
Houston Research Institute - Medical Center
Houston, Texas, United States, 770004
Actively Recruiting
50
Houston Research Institute
Houston, Texas, United States, 77079
Actively Recruiting
51
Houston Research Institute - Pasadena
Pasadena, Texas, United States, 77505
Actively Recruiting
52
Quality Research, Inc.
San Antonio, Texas, United States, 78209
Actively Recruiting
53
Pinnacle Clinical Research - South San Antonio
San Antonio, Texas, United States, 78222
Actively Recruiting
54
Pinnacle Clinical Research
San Antonio, Texas, United States, 78229
Actively Recruiting
55
Sugarland Medical Associates (Sma)
Sugar Land, Texas, United States, 77478
Actively Recruiting
56
Digestive Research of Central Texas
Waco, Texas, United States, 76712
Actively Recruiting
57
Digestive Health Research of North Texas, LLC
Wichita Falls, Texas, United States, 76301
Actively Recruiting
58
GI Select Health Research
Richmond, Virginia, United States, 23236
Actively Recruiting
Research Team
E
Eccogene Clinical Trials
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
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