Drug-Induced Liver InjuryPhase 2NCT06019936

A Randomized,Double-blind, Placebo Controlled, Multicenter Study to Evaluate the Safety and Efficacy of MT2004 Capsule in DILI Subjects

A Phase 2 study testing MT2004 Capsule in people with Drug-Induced Liver Injury and Cholestatic Liver Injury, run by Xi'An Aolitai Pharmaceutical Technology Co Ltd at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Drug-Induced Liver Injury, Cholestatic Liver Injury, Mixed Liver Injury
What is being tested?: MT2004 Capsule
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 80 participants
Where: 1 siteChina
Study dates: 10 Aug 2023to 10 Oct 2025
Phase: Phase 2
Are there results?: None posted in the registry

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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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).

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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.

Who cannot join

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.

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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.

Trial locations and contacts

1 site in 1 country.

LanLan Song, Master contact

+8615929300901

songlanlan@micot.cn

DeChuang Yuan, Master contact

yuandechuang@micot.cn

China1 site, 1 recruiting

Shanghai Jiaotong University School of Medicine,Renji Hospital
Shanghai, Shanghai Municipality, 200001
YiMin Mao, Master, +8613003175438, maoym@163.com
YiMin Mao, Master
Recruiting

Other trials in China

About this study

Official title: 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)

The main questions it aims to answer are:

The Efficacy of MT2004 Capsule in Cholestatic and Mixed DILI subjects
The Safety and Pharmacokinetic characteristic of MT2004 Capsule in Cholestatic and Mixed DILI subjects
The mechanism of using MT2004 Capsule on Cholestatic and Mixed DILI subjects

Read the detailed description

Xi'An Aolitai Pharmaceutical Technology Co Ltd is developing MT2004, a novel investigational synthetic small molecule farnesoid X receptor (FXR) agonist targeted to the liver. The MT2004 was designed as the prodrug and the metabolites MT2004-met1 of MT2004 will act to the FXR receptor to regulate a series of genes expression. It also plays an important role in the metabolism of bile acids, lipids and sugars.

The goal of this randomized, double-blind, placebo controlled, Multicenter Phase II clinical trial is to initially evaluate the Safety and Efficacy of MT2004 Capsule in Cholestatic and Mixed drug induced liver injury (DILI) subjects. The whole study will be divied to three stages including screening period (14 Days before the treatment), treatment period (the participants will be randomized to receive MT2004, or placebo orally (BID), for 12 weeks) and follow-up period. The study aims to recruit total of 80 subjects with Cholestatic and Mixed DILI, in which 12 of subjects will be firstly enrolled and allocated to the MT2004 group (Dose level: 25mg) as well as control group with the proportion of 2:1 by using the stratified randomization method. During the whole study, the adjustment of the subjects amount, the dose level as well as randomization proportion will based on the decesion of Independent Data Monitoring Board (IDMC). The highest dose will not exceed the 50mg BID.

The placebo will be used in this study, and the researchers will compare the placebo and test article to see the safety and efficacy.

Conditions: Drug-Induced Liver Injury, Cholestatic Liver Injury, Mixed Liver Injury
Being tested: MT2004 Capsule, MT2004 Capsule Placebo
Keywords: Drug-Induced Liver Injury
Medical subject headings: Chemical and Drug Induced Liver Injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MT2004 CapsuleDrug
Also called MT2004
The stratified randomization method will be used in this study. In treatment period, the participants will orally receive the MT2004 (BID) for 12 weeks with the dose level of 25mg. The adjustment of the dose level will base on the decesion of Independent Data Monitoring Board (IDMC). The highest dose will not exceed the 50mg BID.
MT2004 Capsule PlaceboDrug
The stratified randomization method will be used in this study. In treatment period, the participants will orally receive the MT2004 Capsule Placebo (BID) for 12 weeks with the dose level of 25mg. The adjustment of the dose level will base on the decesion of Independent Data Monitoring Board (IDMC). The highest dose will not exceed the 50mg BID.

Study groups in NCT06019936
Study group	Role	What they receive
MT2004 Capsule	Experimental	The MT2004 Capsule will be orally used twice daily after meal for 12 weeks. Receives: Drug: MT2004 Capsule
MT2004 Capsule Placebo	Placebo comparator	The MT2004 Capsule Placebo will be orally used twice daily after meal for 12 weeks. Receives: Drug: MT2004 Capsule Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Primary efficacy endpoint
The efficacy of MT2004 will be evaluated based on the decreasing rate on serum ALP compared to baseline.
Measured: On the week 4 after the administration

Secondary outcomes (13)

Secondary efficacy endpoint
The efficacy of MT2004 will be evaluated based on the decreasing rate on ALP compared to baseline.
Measured: On the week 2,8,12 after the administration and the week 4 follow-up period
Secondary efficacy endpoint
The efficacy of MT2004 will be evaluated based on the percentage of patients whose ALP decreased by more than 15% from baseline.
Measured: On the week 2,4,8,12 after the administration and the week 4 follow-up period
Secondary efficacy endpoint
The efficacy of MT2004 will be evaluated based on the recovery rate of ALP.
Measured: On the week 2,4,8,12 after the administration and the week 4 follow-up period
Secondary efficacy endpoint
The efficacy of MT2004 will be evaluated based on the decreasing rate on GGT compared to baseline.
Measured: On the week 2,4,8,12 after the administration and the week 4 follow-up period
Secondary efficacy endpoint
The efficacy of MT2004 will be evaluated based on the recovery rate of GGT.
Measured: On the week 2,4,8,12 after the administration and the week 4 follow-up period
Secondary efficacy endpoint
The efficacy of MT2004 will be evaluated based on the decreasing rate on ALT compared to baseline.
Measured: On the week 2,4,8,12 after the administration and the week 4 follow-up period
Secondary efficacy endpoint
The efficacy of MT2004 will be evaluated based on the recovery rate of ALT.
Measured: On the week 2,4,8,12 after the administration and the week 4 follow-up period
Secondary efficacy endpoint
The efficacy of MT2004 will be evaluated based on the decreasing rate on AST compared to baseline.
Measured: On the week 2,4,8,12 after the administration and the week 4 follow-up period
Secondary efficacy endpoint
The efficacy of MT2004 will be evaluated based on the recovery rate of AST.
Measured: On the week 2,4,8,12 after the administration and the week 4 follow-up period
Secondary efficacy endpoint
The efficacy of MT2004 will be evaluated based on the decreasing rate on TBIL compared to baseline.
Measured: On the week 2,4,8,12 after the administration and the week 4 follow-up period
Secondary efficacy endpoint
The efficacy of MT2004 will be evaluated based on the decreasing rate on TBA compared to baseline.
Measured: On the week 2,4,8,12 after the administration and the week 4 follow-up period
Secondary efficacy endpoint
The efficacy of MT2004 will be evaluated based on the area of serum ALP decreasing rate-time curve.
Measured: On the week 2,4,8,12 after the administration
Secondary efficacy endpoint
The efficacy of MT2004 will be evaluated based on the percentage of patients developed to DILI level 3-4 after the administration.
Measured: On the week 2,4,8,12 after the administration and the week 4 follow-up period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Aug 202310 Oct 2025

First posted31 Aug 2023
Study start10 Aug 2023
Primary completion10 Aug 2025 (estimated)
Study completion10 Oct 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Drug-Induced Liver InjuryStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 80 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06019936
Sponsor's protocol ID: MT2004-II-C01
Other IDs: CTR20232066
Status last verified: Aug 2023
First submitted: 25 Aug 2023
Last updated: 31 Aug 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

LanLan Song, Master

+8615929300901

songlanlan@micot.cn

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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)
ClinicalTrials.gov ID: NCT06019936
Acronym / sponsor ID: MT2004-II-C01
Conditions: Drug-Induced Liver Injury, Cholestatic Liver Injury, Mixed Liver Injury
Keywords: Drug-Induced Liver Injury
Phase: Phase 2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 80 participants (estimated)
Lead sponsor: Xi'An Aolitai Pharmaceutical Technology Co LtdIndustry (pharma, biotech, devices)
Study start: 10 Aug 2023 (actual)
Primary completion: 10 Aug 2025 (estimated)
Study completion: 10 Oct 2025 (estimated)
First posted: 31 Aug 2023 (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.

The main questions it aims to answer are:

The Efficacy of MT2004 Capsule in Cholestatic and Mixed DILI subjects
The Safety and Pharmacokinetic characteristic of MT2004 Capsule in Cholestatic and Mixed DILI subjects
The mechanism of using MT2004 Capsule on Cholestatic and Mixed DILI subjects

Detailed description

The placebo will be used in this study, and the researchers will compare the placebo and test article to see the safety and efficacy.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
MT2004 Capsule	Experimental	Drug: MT2004 CapsuleThe MT2004 Capsule will be orally used twice daily after meal for 12 weeks.
MT2004 Capsule Placebo	Placebo comparator	Drug: MT2004 Capsule PlaceboThe MT2004 Capsule Placebo will be orally used twice daily after meal for 12 weeks.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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.

Key exclusion criteria (14 listed)

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.

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
MT2004 CapsuleAlso: MT2004The stratified randomization method will be used in this study. In treatment period, the participants will orally receive the MT2004 (BID) for 12 weeks with the dose level of 25mg. The adjustment of the dose level will base on the decesion of Independent Data Monitoring Board (IDMC). The highest dose will not exceed the 50mg BID.	Drug	MT2004 Capsule
MT2004 Capsule PlaceboThe stratified randomization method will be used in this study. In treatment period, the participants will orally receive the MT2004 Capsule Placebo (BID) for 12 weeks with the dose level of 25mg. The adjustment of the dose level will base on the decesion of Independent Data Monitoring Board (IDMC). The highest dose will not exceed the 50mg BID.	Drug	MT2004 Capsule Placebo

Primary outcome

Primary efficacy endpoint
Time frame: On the week 4 after the administration
The efficacy of MT2004 will be evaluated based on the decreasing rate on serum ALP compared to baseline.

13 secondary outcomes

Secondary efficacy endpoint
Time frame: On the week 2,8,12 after the administration and the week 4 follow-up period
Secondary efficacy endpoint
Time frame: On the week 2,4,8,12 after the administration and the week 4 follow-up period
Secondary efficacy endpoint
Time frame: On the week 2,4,8,12 after the administration and the week 4 follow-up period
Secondary efficacy endpoint
Time frame: On the week 2,4,8,12 after the administration and the week 4 follow-up period
Secondary efficacy endpoint
Time frame: On the week 2,4,8,12 after the administration and the week 4 follow-up period
Secondary efficacy endpoint
Time frame: On the week 2,4,8,12 after the administration and the week 4 follow-up period
Secondary efficacy endpoint
Time frame: On the week 2,4,8,12 after the administration and the week 4 follow-up period
Secondary efficacy endpoint
Time frame: On the week 2,4,8,12 after the administration and the week 4 follow-up period
Secondary efficacy endpoint
Time frame: On the week 2,4,8,12 after the administration and the week 4 follow-up period
Secondary efficacy endpoint
Time frame: On the week 2,4,8,12 after the administration and the week 4 follow-up period
Secondary efficacy endpoint
Time frame: On the week 2,4,8,12 after the administration and the week 4 follow-up period
Secondary efficacy endpoint
Time frame: On the week 2,4,8,12 after the administration
Secondary efficacy endpoint
Time frame: On the week 2,4,8,12 after the administration and the week 4 follow-up period

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.

Related trials for Drug-Induced Liver Injury

Not yet recruitingEarly Phase 1
Silymarin Versus N-Acetylcysteine as Protective Effect Against Anti-tuberculosis Drugs Induced Liver Injury.
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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. This study is not recruiting at the moment.

LanLan Song, Master contact

+8615929300901

songlanlan@micot.cn

DeChuang Yuan, Master contact

yuandechuang@micot.cn

YiMin Mao, Master principal investigator

RenJi Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MT2004 Capsule in people with Drug-Induced Liver Injury and Cholestatic Liver Injury, run by Xi'An Aolitai Pharmaceutical Technology Co Ltd at 1 site in China.

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 9 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 31 Aug 2023. 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 China. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact LanLan Song, Master (+8615929300901, songlanlan@micot.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary efficacy endpoint (time frame: On the week 4 after the administration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06019936.

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 31 Aug 2023.