Actively Recruiting
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)
Led by Eccogene · Updated on 2026-04-22
160
Participants Needed
53
Research Sites
93 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 written informed consent and comply with study procedures
- Diagnosis of presumed MASH based on liver biopsy within 180 days with NAFLD activity score 63 and fibrosis score F1-3, or FibroScan CAP >280 dB/m with metabolic risk factors
- Evidence of hepatic steatosis confirmed by FibroScan LSM >7 kPa and <20 kPa and MRI-PDFF >8% at screening
- BMI >25 to <50 kg/m2 (non-Asian) or BMI 63 23.0 to <50.0 kg/m2 (Asian)
- ALT 60 U/L at first screening visit and stable ALT and AST levels during screening
- Estimated glomerular filtration rate (eGFR) 60 mL/min/1.73m2
- Stable body weight (no >5% change) for at least 6 months prior to screening
- Willing to comply with contraception requirements if applicable
- Able to safely participate and complete MRI/biomarker assessments per investigator
You will not qualify if you...
- Chronic liver diseases other than metabolic dysfunction-associated steatotic liver disease, 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 >5 times upper limit of normal or ALP >2 times upper limit of normal at screening
- Clinically significant thyroid or adrenal dysfunction, including uncontrolled hypothyroidism or hyperthyroidism
- Type 1 diabetes, HbA1c >9.5%, or unstable type 2 diabetes requiring medication changes within 90 days
- Use of medications affecting liver fat or fibrosis within protocol-specified washout periods
- Significant alcohol use within 1 year prior to screening
- Recent cardiovascular events such as myocardial infarction, stroke, unstable angina, heart failure (NYHA III-IV), or uncontrolled arrhythmia
- Current or recent serious psychiatric illness including psychosis, active suicidal ideation, or suicide attempt within 5 years
- Pregnancy, breastfeeding, or conditions increasing risk or interfering with study procedures including MRI contraindications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 53 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
ARK Clinical Research - Fountain Valley
Fountain Valley, California, United States, 92708
Actively Recruiting
8
Ark Clinical Research
Long Beach, California, United States, 90815
Actively Recruiting
9
Knowledge Research Center
Orange, California, United States, 92868
Actively Recruiting
10
Synergy Healthcare
Bradenton, Florida, United States, 33511
Actively Recruiting
11
Synergy Healthcare
Bradenton, Florida, United States, 34209
Actively Recruiting
12
Health Awareness, Inc.
Jupiter, Florida, United States, 33458
Actively Recruiting
13
Evolution Clinical Trials
Miami, Florida, United States, 33122
Actively Recruiting
14
Floridian Clinical Research, LLC
Miami Lakes, Florida, United States, 33016
Actively Recruiting
15
Ocala GI Research
Ocala, Florida, United States, 34471
Actively Recruiting
16
Progressive Medical Research
Port Orange, Florida, United States, 32127
Actively Recruiting
17
ClinCloud, LLC
Viera, Florida, United States, 32940
Actively Recruiting
18
CenExel - iResearch
Decatur, Georgia, United States, 30030
Actively Recruiting
19
Gastrointestinal Specialists of Georgia, PC
Marietta, Georgia, United States, 30060
Actively Recruiting
20
Digestive Research Alliance of Michiana
South Bend, Indiana, United States, 46635
Actively Recruiting
21
Tandem Clinical Research
Covington, Louisiana, United States, 70433
Actively Recruiting
22
Tandem Clinical Research
Houma, Louisiana, United States, 70360
Actively Recruiting
23
Tandem Clinical Research GI, LLC
Marrero, Louisiana, United States, 70072
Actively Recruiting
24
Tandem Clinical Research
Metairie, Louisiana, United States, 70006
Actively Recruiting
25
Delta Research Partners
Monroe, Louisiana, United States, 71201
Actively Recruiting
26
Louisiana Research Center, LLC
Shreveport, Louisiana, United States, 71105
Actively Recruiting
27
Delta Research Partners, LLC
West Monroe, Louisiana, United States, 71291
Actively Recruiting
28
Mid-Atlantic GI Research
Greenbelt, Maryland, United States, 20770
Actively Recruiting
29
Gastrointestinal Associates
Columbia, Missouri, United States, 65201
Actively Recruiting
30
Gateway GI Research, LLC
St Louis, Missouri, United States, 63141
Actively Recruiting
31
Premier Health Research
Sparta, New Jersey, United States, 07871
Actively Recruiting
32
Akron Gastro Research
Akron, Ohio, United States, 44333
Actively Recruiting
33
Digestive Specialists
Dayton, Ohio, United States, 45414
Actively Recruiting
34
DSI Research
Springboro, Ohio, United States, 45066
Actively Recruiting
35
Columbia Gastroenterology Associates, Llc
Columbia, South Carolina, United States, 29204
Actively Recruiting
36
Pinnacle Clinical Research
Austin, Texas, United States, 78757
Actively Recruiting
37
Bellaire Clinical Research
Bellaire, Texas, United States, 77401
Actively Recruiting
38
South Texas Research Institute (STRI) - Brownsville
Brownsville, Texas, United States, 78520
Actively Recruiting
39
Pinnacle Clinical Research
Corpus Christi, Texas, United States, 78404
Actively Recruiting
40
South Texas Research Institute (STRI)
Edinburg, Texas, United States, 78539
Actively Recruiting
41
Dallas Research Institute, LLC
Farmers Branch, Texas, United States, 75234
Actively Recruiting
42
Care United Research
Forney, Texas, United States, 75126
Actively Recruiting
43
Pinnacle Clinical Research - Georgetown
Georgetown, Texas, United States, 78626
Actively Recruiting
44
Houston Research Institute - Medical Center
Houston, Texas, United States, 770004
Actively Recruiting
45
Houston Research Institute
Houston, Texas, United States, 77079
Actively Recruiting
46
Houston Research Institute - Pasadena
Pasadena, Texas, United States, 77505
Actively Recruiting
47
Quality Research, Inc.
San Antonio, Texas, United States, 78209
Actively Recruiting
48
Pinnacle Clinical Research - South San Antonio
San Antonio, Texas, United States, 78222
Actively Recruiting
49
Pinnacle Clinical Research
San Antonio, Texas, United States, 78229
Actively Recruiting
50
Sugarland Medical Associates (Sma)
Sugar Land, Texas, United States, 77478
Actively Recruiting
51
Digestive Research of Central Texas
Waco, Texas, United States, 76712
Actively Recruiting
52
Digestive Health Research of North Texas, LLC
Wichita Falls, Texas, United States, 76301
Actively Recruiting
53
GI Select Health Research
Richmond, Virginia, United States, 23236
Actively Recruiting
Research Team
E
Eccogene Clinical Trials
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here