Evaluating MT2004 Capsule for Drug-Induced Liver Injury

A Randomized,Double-blind, Placebo Controlled, Multicenter Study to Evaluate the Safety and Efficacy of MT2004 Capsule in Treatment of Cholestatic and Mixed Drug Induced Liver Injury (DILI)

This study is testing whether the MT2004 capsule can help improve liver function in adults with drug-induced liver injury.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Shaanxi Micot Technology Limited Company (Industry-sponsored)
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT06019936 on ClinicalTrials.gov

What this trial studies

This clinical trial is a randomized, double-blind, placebo-controlled study aimed at assessing the safety and efficacy of the MT2004 capsule in patients with cholestatic and mixed drug-induced liver injury (DILI). Participants aged 18 to 75 will be screened and randomized to receive either the MT2004 capsule or a placebo for a treatment period of 12 weeks. The study will monitor the pharmacokinetics and mechanisms of action of MT2004, which is designed to activate the farnesoid X receptor in the liver, potentially improving liver function. A total of 80 subjects will be recruited across multiple centers, with adjustments made based on independent monitoring board recommendations.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 75 who have been diagnosed with cholestatic or mixed drug-induced liver injury.

Not a fit: Patients with other common causes of acute liver injury, such as viral hepatitis or autoimmune hepatitis, will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from drug-induced liver injury.

How similar studies have performed: While this approach is novel in the context of MT2004, similar studies targeting liver injury have shown promising results in the past.

Eligibility criteria

Inclusion Criteria:

* 1. 18≤ age ≤ 75 years, male or female.

  2. When diagnosis of acute DILI, the liver biochemical threshold of patients must meet one of the following criteria: ：(1) ALT ≥5 ×ULN；(2) ALP ≥2× ULN；(3) ALT≥3× ULN and TBil ≥2×ULN.

  3. ALP ≥2× ULN, and conform to the clinical classification of cholestatic type or mixed type DILI in the Chinese Guidelines for the Diagnosis and Treatment of Drug-induced Liver Injury (2023 edition) (cholestatic type: R value ≤2; Mixed type: 2\<R value \<5).

  4. Excluded other common causes of acute liver injury, such as acute viral hepatitis A, B, C, E, autoimmune hepatitis, biliary tract disease, PBC, etc. (Exclusive diagnostic tests completed in our hospital or other hospitals after this suspected acute DILI event or within 2 months before screening were acceptable)

  5. RUCAM causality scale score ≥6 points; If the RUCAM score is between the 3-5 it is necessary to evaluate the causal relationship by three experts according to the evaluation criteria of expert opinions in the Chinese Guidelines for the Diagnosis and Treatment of Drug-induced Liver Injury (2023 edition), and at least two experts determine that the liver injury of the patients are "likely", "very likely" or "definitely" caused by drugs.

  6. The serious level of DILI is within level 1-2 based on the Chinese Guidelines for the Diagnosis and Treatment of Drug-induced Liver Injury (2023 edition).

  7. The duration of this liver injury is less than 6 months.

  8. The female with fertility must have had a negative pregnancy test results before being enrolled, or at least 1 year after pausimenia, or permanent sterilization ≥6 weeks（There should have a recording of hysterectomy, bilateral salpingo-oophorectomy）. The female and their male partners with the fertility potential agree to utilize the effective contraceptive methods（the following two methods can be selected: 1. any of the condom, diaphragm, Sponge or Cervical Cap with with Spermicide ）.

  9. Fully understand the study process of the clinical trial, and provide the signed ICF of joinning the clinical trial.

Exclusion Criteria:

* 1. Acute or chronic liver failure or liver decompensation

  2. The history of liver decompensation or portal hypertension history

  3. Moderate or above renal insufficiency, creatinine clearance (Ccr) \< 60mL/min (according to the MDRD formula).

  4. Patients with serious diabetes and had poor control of blood sugar (HbA1c\>10%)

  5. Serious sysmetic diseases of cardiovascular, respiratory, neurological, urinary, digestive, and for any reason which, in the opinion of the Investigator think the subject is not suitable for participating in the study.

  6. The predict survival period \< 6 months.

  7. Utilization of Perursodeoxycholic acid within 14 days before the treatment.

  8. Utilization of S-adenosylmethionine within 1 days before the treatment.

  9. The patients must regularly utilize the known strong CYP3A4/3A5 inhibitors such as Clarithromycin, Itraconazole, ketoconazole, Ritonavir, rifampicin, phenytoin, carbamazepine within 1 week before the treatment or for the whole study period.

  10. Allergies or intolerances to study drug ingredients

  11. Patients are under the gestation, lactation, or patients have the pregnancy planning during the study period and 90 days after the end of the clinical trial

  12. Patients are not willing to ban the alcohol during the study period.

  13. Patients had joined the other clinical trials within 3 months before the administration.

  14. Other conditions that the investigator think the subject is not suitable for participating in the study.

Where this trial is running

Shanghai, Shanghai

• Shanghai Jiaotong University School of Medicine,Renji Hospital — Shanghai, Shanghai, China (Recruiting)

Study contacts

• Principal investigator: YiMin Mao, Master — Shanghai Jiaotong University School of Medicine,Renji Hospital
• Study coordinator: LanLan Song, Master

Conditions Drug-Induced Liver Injury; Cholestatic Liver Injury; Mixed Liver Injury