Non-alcoholic Fatty Liver Disease (NAFLD)Phase 1NCT07726368
Study of ECC4703 With Sulfasalazine and Pitavastatin
A Phase 1 study testing ECC4703, Sulfasalazine and Pitavastatin in people with Non-alcoholic Fatty Liver Disease (NAFLD) and Dyslipidaemia, run by Eccogene at 1 site in Australia.
Trial summary
Non-alcoholic fatty liver disease is a chronic, serious, life-threatening, inflammatory liver disease characterized by increased liver fat content, inflammation, and progressive fibrosis. The overall prevalence of non-alcoholic fatty liver disease is rapidly rising world-wide. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-alcoholic Fatty Liver Disease (NAFLD), Dyslipidaemia
- What is being tested?
- ECC4703, Sulfasalazine and Pitavastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteAustralia
- Study dates
- 7 Aug 2026to Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Nucleus Network Pty Ltd
Melbourne, Victoria, 3004
Dr Ofer Gonen, +61 0431 614 515, o.gonen@nucleusnetwork.com.au
About this study
Official title: A Phase 1, Open-Label, Fixed-Sequence, Single-Center, Two-Period, Drug-Drug Interaction Trial in Healthy Adult Participants to Evaluate the Effect of Steady-State ECC4703 on the Pharmacokinetics of Sulfasalazine (BCRP Probe Substrate) and Pitavastatin (OATP1B1/OATP1B3 Probe Substrate)
Non-alcoholic fatty liver disease is a chronic, serious, life-threatening, inflammatory liver disease characterized by increased liver fat content, inflammation, and progressive fibrosis. The overall prevalence of non-alcoholic fatty liver disease is rapidly rising world-wide.
ECC4703 is a potential new treatment for non-alcoholic fatty liver disease.
The purpose of this research is to investigate the safety, tolerability and pharmacokinetics of sulfasalazine and pitavastatin when combined with ECC4703.
- Being tested
- ECC4703, Sulfasalazine, Pitavastatin
- Keywords
- BCRP inhibitor, OATP inhibitor
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECC4703Drug
ECC4703 will be administered orally.
SulfasalazineDrug
Sulfasalazine will be administered orally.
PitavastatinDrug
Pitavastatin will be administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 - ECC4703 and Sulfasalazine | Experimental | Cohort 1 participants will receive ECC4703 and sulfasalazine. Receives: Drug: ECC4703; Drug: Sulfasalazine |
| Cohort 2 - ECC4703 and Pitavastatin | Experimental | Cohort 2 participants will receive ECC4703 and pitavastatin. Receives: Drug: ECC4703; Drug: Pitavastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma concentration of sulfasalazine in the blood of participants who have taken ECC4703 (as part of called pharmacokinetic or 'PK' testing)
Measured: Blood samples for PK testing of sulfasalazine will be collected on Days 1, 2, 3, 4, 9, 10, 11 and 12
Time to maximum plasma concentration of sulfasalazine in the blood of participants who have taken ECC4703 (as part of called pharmacokinetic or 'PK' testing)
Measured: Blood samples for PK testing of sulfasalazine will be collected on Days 1, 2, 3, 4, 9, 10, 11 and 12
Area under the drug concentration-time curve of sulfasalazine in the blood of participants who have taken ECC4703 (as part of called pharmacokinetic or 'PK' testing)
Measured: Blood samples for PK testing of sulfasalazine will be collected on Days 1, 2, 3, 4, 9, 10, 11 and 12
Clearance of sulfasalazine in the blood of participants who have taken ECC4703 (as part of called pharmacokinetic or 'PK' testing)
Measured: Blood samples for PK testing of sulfasalazine will be collected on Days 1, 2, 3, 4, 9, 10, 11 and 12
Maximum plasma concentration of pitavastatin in the blood of participants who have taken ECC4703 (as part of called pharmacokinetic or 'PK' testing)
Measured: Blood samples for PK testing of pitavastatin will be collected on Days 1, 2, 3, 4, 9, 10, 11 and 12
Time to maximum plasma concentration of pitavastatin in the blood of participants who have taken ECC4703 (as part of called pharmacokinetic or 'PK' testing)
Measured: Blood samples for PK testing of pitavastatin will be collected on Days 1, 2, 3, 4, 9, 10, 11 and 12
Area under the drug concentration-time curve of pitavastatin in the blood of participants who have taken ECC4703 (as part of called pharmacokinetic or 'PK' testing)
Measured: Blood samples for PK testing of pitavastatin will be collected on Days 1, 2, 3, 4, 9, 10, 11 and 12
Clearance of pitavastatin in the blood of participants who have taken ECC4703 (as part of called pharmacokinetic or 'PK' testing)
Measured: Blood samples for PK testing of pitavastatin will be collected on Days 1, 2, 3, 4, 9, 10, 11 and 12
Secondary outcomes (6)
Number of participants with Adverse Events (AEs), as assessed by a 5-point scale, CTCAE v5.0
Adverse event monitoring includes measuring the frequency, severity and relationship of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) leading to treatment or study discontinuation. Severity of adverse events will be characterised from 1 (mild) to 5 (death).
Measured: From baseline to follow-up visit (on Day 19).
Change from Baseline in blood pressure, measured using a sphygmomanometer via a cuff on the arm
Measured: From baseline to follow-up visit (on Day 19).
Change from Baseline in heart rate, measured in beats-per-minute by a vital signs machine
Measured: From Baseline to follow-up visit (on Day 19).
Change from Baseline in respiratory rate, measured in breaths-per-minute manually via a 60-second count
Measured: From Baseline to follow-up visit (on Day 19).
Change from Baseline in body temperature in degrees Celsius, measured using a thermometer
Measured: From Baseline to follow-up visit (on Day 19).
Changes from Baseline in Clinical Laboratory Parameters including, but not limited to, haematology and blood chemistry.
Blood samples will be collected. All safety laboratory assessments will be assessed by a certified local laboratory, using that laboratory's normal ranges. Any clinically significant changes will be recorded as Adverse Event (AE). The severity of each AE (and SAE or Serious Adverse Event) will be graded using a 5-point scale
Measured: From baseline to follow-up visit (on Day 19)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start7 Aug 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-alcoholic Fatty Liver Disease (NAFLD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eccogene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07726368
- Sponsor's protocol ID
- EC0012
- Status last verified
- Sep 2026
- First submitted
- 13 Jul 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Fixed-Sequence, Single-Center, Two-Period, Drug-Drug Interaction Trial in Healthy Adult Participants to Evaluate the Effect of Steady-State ECC4703 on the Pharmacokinetics of Sulfasalazine (BCRP Probe Substrate) and Pitavastatin (OATP1B1/OATP1B3 Probe Substrate)
- ClinicalTrials.gov ID
- NCT07726368
- Acronym / sponsor ID
- EC0012
- Keywords
- BCRP inhibitor, OATP inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- EccogeneIndustry (pharma, biotech, devices)
- Study start
- 7 Aug 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 24 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Non-alcoholic fatty liver disease is a chronic, serious, life-threatening, inflammatory liver disease characterized by increased liver fat content, inflammation, and progressive fibrosis. The overall prevalence of non-alcoholic fatty liver disease is rapidly rising world-wide.
ECC4703 is a potential new treatment for non-alcoholic fatty liver disease.
The purpose of this research is to investigate the safety, tolerability and pharmacokinetics of sulfasalazine and pitavastatin when combined with ECC4703.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 - ECC4703 and Sulfasalazine | Experimental | Drug: ECC4703, Drug: SulfasalazineCohort 1 participants will receive ECC4703 and sulfasalazine. |
| Cohort 2 - ECC4703 and Pitavastatin | Experimental | Drug: ECC4703, Drug: PitavastatinCohort 2 participants will receive ECC4703 and pitavastatin. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECC4703ECC4703 will be administered orally. | Drug | Cohort 1 - ECC4703 and Sulfasalazine, Cohort 2 - ECC4703 and Pitavastatin |
| SulfasalazineSulfasalazine will be administered orally. | Drug | Cohort 1 - ECC4703 and Sulfasalazine |
| PitavastatinPitavastatin will be administered orally. | Drug | Cohort 2 - ECC4703 and Pitavastatin |
Primary outcome
Maximum plasma concentration of sulfasalazine in the blood of participants who have taken ECC4703 (as part of called pharmacokinetic or 'PK' testing)
Time frame: Blood samples for PK testing of sulfasalazine will be collected on Days 1, 2, 3, 4, 9, 10, 11 and 12
Time to maximum plasma concentration of sulfasalazine in the blood of participants who have taken ECC4703 (as part of called pharmacokinetic or 'PK' testing)
Time frame: Blood samples for PK testing of sulfasalazine will be collected on Days 1, 2, 3, 4, 9, 10, 11 and 12
Area under the drug concentration-time curve of sulfasalazine in the blood of participants who have taken ECC4703 (as part of called pharmacokinetic or 'PK' testing)
Time frame: Blood samples for PK testing of sulfasalazine will be collected on Days 1, 2, 3, 4, 9, 10, 11 and 12
Clearance of sulfasalazine in the blood of participants who have taken ECC4703 (as part of called pharmacokinetic or 'PK' testing)
Time frame: Blood samples for PK testing of sulfasalazine will be collected on Days 1, 2, 3, 4, 9, 10, 11 and 12
Maximum plasma concentration of pitavastatin in the blood of participants who have taken ECC4703 (as part of called pharmacokinetic or 'PK' testing)
Time frame: Blood samples for PK testing of pitavastatin will be collected on Days 1, 2, 3, 4, 9, 10, 11 and 12
Time to maximum plasma concentration of pitavastatin in the blood of participants who have taken ECC4703 (as part of called pharmacokinetic or 'PK' testing)
Time frame: Blood samples for PK testing of pitavastatin will be collected on Days 1, 2, 3, 4, 9, 10, 11 and 12
Area under the drug concentration-time curve of pitavastatin in the blood of participants who have taken ECC4703 (as part of called pharmacokinetic or 'PK' testing)
Time frame: Blood samples for PK testing of pitavastatin will be collected on Days 1, 2, 3, 4, 9, 10, 11 and 12
Clearance of pitavastatin in the blood of participants who have taken ECC4703 (as part of called pharmacokinetic or 'PK' testing)
Time frame: Blood samples for PK testing of pitavastatin will be collected on Days 1, 2, 3, 4, 9, 10, 11 and 12
6 secondary outcomes
Number of participants with Adverse Events (AEs), as assessed by a 5-point scale, CTCAE v5.0
Time frame: From baseline to follow-up visit (on Day 19).
Change from Baseline in blood pressure, measured using a sphygmomanometer via a cuff on the arm
Time frame: From baseline to follow-up visit (on Day 19).
Change from Baseline in heart rate, measured in beats-per-minute by a vital signs machine
Time frame: From Baseline to follow-up visit (on Day 19).
Change from Baseline in respiratory rate, measured in breaths-per-minute manually via a 60-second count
Time frame: From Baseline to follow-up visit (on Day 19).
Change from Baseline in body temperature in degrees Celsius, measured using a thermometer
Time frame: From Baseline to follow-up visit (on Day 19).
Changes from Baseline in Clinical Laboratory Parameters including, but not limited to, haematology and blood chemistry.
Time frame: From baseline to follow-up visit (on Day 19)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ECC4703, Sulfasalazine and Pitavastatin in people with Non-alcoholic Fatty Liver Disease (NAFLD) and Dyslipidaemia, run by Eccogene at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eccogene Clinical Trials (86-21-61053022, contact@eccogene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum plasma concentration of sulfasalazine in the blood of participants who have taken ECC4703 (as part of called pharmacokinetic or 'PK' testing) (time frame: Blood samples for PK testing of sulfasalazine will be collected on Days 1, 2, 3, 4, 9, 10, 11 and 12). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.