ECC4703 with Sulfasalazine and Pitavastatin in adults with NAFLD and dyslipidemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1 interventional study examining the safety, tolerability, and pharmacokinetics of ECC4703 when given together with sulfasalazine and pitavastatin. The trial enrolls adults aged 18 to 65 who are generally healthy aside from potential NAFLD/dyslipidemia risk factors as determined by investigators. Participants will undergo clinical assessments, monitoring, and laboratory tests to characterize potential drug interactions and safety signals. The study is led by Eccogene with Nucleus Network as the site in Melbourne, Australia. Primary outcomes focus on safety and how the combination is processed in the body; exploratory aims may inform future dosing and development.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Male or female between the ages of 18 and 65 years, inclusive, at the time of Screening.
* Are healthy and in the opinion of the Investigator have an acceptable medical history (free from significant cardiac, pulmonary, gastrointestinal, hepatic, renal, haematological, neurological, infective, or psychiatric diseases as determined by medical history over the past 5 years, physical examination, vital signs, 12-lead ECG, and clinical laboratory tests).
* Has not consumed and agrees to abstain from taking any prescription drugs or non-prescription drugs for 7 days or 5 half-lives (whichever is longer) prior to first dose of trial treatment and continuing through end of the Treatment Period.

Exclusion Criteria:

* Has a history of significant renal, hepatic, cardiovascular, psychiatric, neoplastic, thyroid disease/abnormality or other disease which, in the opinion of the Investigator, represents a safety risk for taking part in the trial.
* Has a history of sensitivity to any of the trial treatments (and/or their excipients), or severe drug or other allergy
* Has a history of drug abuse within the previous 2 years, or a positive drug screen at Screening and/or Day -1.
* Regular consumption of more than 10 standard alcoholic drinks/week and/or more than 4 standard alcoholic drinks on any one day
* Has a history or current diagnosis of a significant psychiatric disorder that would, in the opinion of the Investigator, affect the participant's ability to comply with the trial requirements.
* Has a personal or family history of hereditary muscular disorders, previous statin-induced myopathy/rhabdomyolysis, or unexplained repeated or severe muscle pain.
* Has a history of any unexplained chronic skin rash or autoimmune skin diseases.
* Has a personal or family history of Stevens-Johnson syndrome (SJS), or other severe drug-induced skin reactions.
* History of surgery or hospitalisation within 3 months prior to screening, or surgery planned during the study.

Where it's running

• Nucleus Network Pty Ltd
  Melbourne, Victoria, Australia Recruiting

Study contacts

• Study coordinator: Eccogene Clinical Trials
• Email: contact@eccogene.com
• Phone: 86-21-61053022

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• High BMI and periodontitis in Thai adults under 60

  This study tests how common high BMI and periodontitis are among Thai adults aged 18–59 and what factors are linked to them.

  Recruiting Mahidol University · Bangkok, Ratchathewi · NCT07880717

• New virtual care pathway for older adults with chronic diseases

  A teleconsultation-based care pathway for adults 60+ with hypertension, diabetes, or dyslipidemia to see if it’s feasible and cost-saving in Malaysian primary care compared with usual clinic visits.

  Recruiting National University of Malaysia · Kuala Lumpur · NCT07843238

• Taiwan green propolis for MASLD and lipid/metabolic issues

  This study tests whether Taiwan green propolis capsules can improve blood lipids and body fat in adults with MASLD compared to a placebo over 12 weeks.

  Recruiting Taipei Medical University · Dalin · NCT07692438

• Automated Passive Case-Finding for Advanced Liver Fibrosis in MASLD

  This program automatically screens high‑risk adults aged 50–75 in primary care to see if they have advanced liver fibrosis and possible MASLD, using routine blood tests and reflex lab tests without extra work for clinicians.

  Recruiting Hospital General Universitario Gregorio Marañon · Madrid, Madrid · NCT07658755

• Single-cell and spatial mapping of liver degeneration and regeneration

  This project will try to use single-cell and spatial omics on preoperative blood and discarded liver tissue from people having liver surgery or biopsy to map how cells change during fatty liver, HBV infection, fibrosis, and cirrhosis.

  Recruiting Nanfang Hospital, Southern Medical University · Guangzhou, Guangdong · NCT07265544

• Telehealth program for weight management and related health issues

  This study is testing a new telehealth program for weight management to see if it helps obese adults with type 2 diabetes and liver issues lose weight and improve their health better than traditional in-person programs.

  Recruiting Changi General Hospital · Singapore · NCT06890169

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.