ECC4703 + ECC0509 for Fatty Liver Disease

Overseen By Eccogene Clinical Trials

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Eccogene

Must not be taking: GLP-1 RAs, Pioglitazone

Disqualifiers: Chronic liver disease, Cirrhosis, Type 1 diabetes, Significant alcohol use, Recent cardiovascular events, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how two treatments, ECC4703 and ECC0509, can reduce liver fat in individuals with fatty liver disease. Researchers are testing various doses of each treatment, both alone and in combination, to identify the most effective option. The trial is ideal for those diagnosed with fatty liver through a recent liver biopsy or similar tests, who have a stable body weight, and are not taking medications that affect the liver. The goal is to assess whether these treatments can lower liver fat levels, with MRI scans measuring changes over 12 weeks. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that ECC4703 has undergone safety testing in healthy individuals. The study assessed side effects, lab results, heart and health checks, and physical exams over a short period. This indicates that ECC4703 is being closely monitored for safety in humans.

For ECC0509, earlier research supports its continued development as a once-daily pill, suggesting it has been tolerated well enough to proceed with further testing in people.

Regarding the combined use of ECC4703 and ECC0509, early studies conducted before human testing suggest the combination might improve liver conditions. While these results are promising, early studies don't always predict human reactions.

Overall, since this trial is in the middle phase of testing, ECC4703 and ECC0509 have demonstrated sufficient safety to reach this stage. This usually indicates the treatments are considered reasonably safe, but ongoing trials will provide more detailed safety information. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about ECC4703 and ECC0509 for treating fatty liver disease because these treatments offer unique approaches compared to standard options like lifestyle changes and medications such as vitamin E and pioglitazone. ECC4703 and ECC0509 have novel mechanisms of action that specifically target pathways involved in liver fat accumulation and inflammation, which are not directly addressed by current treatments. Moreover, these investigational drugs are administered in varying doses, allowing researchers to explore optimal dosing strategies for maximum effectiveness. This innovative approach could potentially lead to more effective management of fatty liver disease, offering hope for improved patient outcomes.

What evidence suggests that this trial's treatments could be effective for fatty liver disease?

Research shows that ECC4703, which participants in this trial may receive, can lower certain blood fats linked to fatty liver disease, including a significant reduction in LDL, often called "bad cholesterol." This reduction might help decrease liver fat. For ECC0509, another treatment option in this trial, studies suggest it could be developed as a pill to treat metabolic-associated liver disease, indicating potential improvements in liver health. Early research suggests that using ECC4703 and ECC0509 together, as tested in one of the trial arms, could further enhance liver conditions by working in different ways. This combination might make the treatment more effective in reducing liver fat. ^{1 2 4 5 6}

Who Is on the Research Team?

Eccogene Clinical Trials

Principal Investigator

Eccogene

Are You a Good Fit for This Trial?

Adults over 18 with presumed MASH, confirmed by liver biopsy or non-invasive criteria, who have a stable body weight and are willing to use contraception. They should have fatty liver disease (MRI-PDFF >8%), BMI within specified ranges depending on ethnicity, elevated ALT levels, and normal kidney function. Those unable to undergo MRI or complete the study are excluded.

Inclusion Criteria

My ALT levels are not more than 1.5 times the normal upper limit.

My liver condition is confirmed by a biopsy or a FibroScan showing fibrosis.

I am 18 or older and can follow the study's procedures.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ECC4703, ECC0509, or their combination to assess hepatic fat reduction over 12 weeks

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ECC0509
• ECC4703

Trial Overview

The trial is testing ECC4703 and ECC0509, both alone and in combination, at different doses for their effects on reducing hepatic fat as measured by MRI-PDFF after 12 weeks. Participants will be randomly assigned to receive one of these treatments or a placebo.

How Is the Trial Designed?

Group I: ECC4703 Low Dose Experimental Treatment 1 Intervention

Group II: ECC4703 High Dose + ECC0509 High Dose Experimental Treatment 2 Interventions

Group III: ECC4703 High Dose Experimental Treatment 1 Intervention

Group IV: ECC0509 Low Dose Experimental Treatment 1 Intervention

Group V: ECC0509 High Dose Experimental Treatment 1 Intervention

Group VI: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Eccogene

Lead Sponsor

Trials

5

Recruited

300+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07288138

NCT07288138 | A Study of a Thyroid Hormone Receptor ...

The primary objective of this trial is to evaluate the dose-dependent and comparative effects of ECC4703 (low and high dose), ECC0509 (low and ...

2.

eccogene.com

eccogene.com/wp-content/uploads/AASLD-2024_ECC0509-poster-5020_print-36inx70in.pdf

Safety, Tolerability, Pharmacokinetics and ...

Overall, these data support continued development of ECC0509 as a potential oral once-daily therapy for patients with MASH. Poster No. 5020. Fig 4: Plasma ...

3.

cdek.pharmacy.purdue.edu

cdek.pharmacy.purdue.edu/trial/NCT07288138/

Trial | NCT07288138

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 ...

4.

delta.larvol.com

delta.larvol.com/Products/?ProductId=4003ac2b-64c7-48a0-b3e0-ef71d8cecb7f

ECC0509 / Eccogene

Eccogene Announces First Patient Enrolled in MOSAIC Phase 2a Trial Evaluating ECC4703 and ECC0509, Individually and in Combination, for the Treatment of ...

5.

researchgate.net

researchgate.net/publication/376498012_Characteristics_of_contemporary_drug_clinical_trials_regarding_the_treatment_of_non-alcoholic_steatohepatitis

(PDF) Characteristics of contemporary drug clinical trials ...

Metabolic diseases, including obesity, diabetes, and nonalcoholic fatty liver disease (NAFLD), are rising in both incidence and prevalence ...

6.

ichgcp.net

ichgcp.net/amp/clinical-trials-registry/NCT07288138

ECC4703 and ECC0509 in Metabolic Dysfunction-associated ...

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), ...