Metabolic Dysfunction Associated Fatty Liver DiseaseNCT06773221
The Efficacy and Safety of Chiglitazar in Patients with MAFLD-related Cirrhosis
A study testing Chiglitazar 64mg in people with Metabolic Dysfunction Associated Fatty Liver Disease and Compensated Liver Cirrhosis, run by Beijing Friendship Hospital at 4 sites in China.
Trial summary
A total of 195 adult patients with biopsy-proven or clinically diagnosed metabolic dysfunction-associated with fatty liver disease(MAFLD)-related cirrhosis will be randomly divided into two arms. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metabolic Dysfunction Associated Fatty Liver Disease, Compensated Liver Cirrhosis
- What is being tested?
- Chiglitazar 64mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 195 participants
- Where
- 4 sitesChina
- Study dates
- 5 Feb 2025to 30 Jun 2028
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Men and women aged between 18 and 75 years (inclusive) who understand and sign informed consent forms; 2. Compensated MAFLD-related cirrhosis diagnosis(meet one of the following conditions):
- The liver biopsy during the screening period (liver biopsy within 6 months of screening is acceptable) showing cirrhosis with steatohepatitis according to the Non Alcoholic Fatty Liver Disease Clinical Research Network (NASH-CRN) scoring system, and there is no evidence of competitive aetiology.
- The liver biopsy during the screening period (liver biopsy within 6 months of screening is acceptable) showing cirrhosis with steatosis (no steatohepatitis) according to NASH-CRN scoring system, and there is no evidence of competitive aetiology. There are at least 2 coexisting metabolic comorbidities or history of metabolic comorbidities, including obesity and/or type 2 diabetes mellitus (T2DM).
- Historical biopsy showed steatohepatitis, and now diagnosed with cirrhosis through non-invasive tests or clinical criteria (see criterion (5)-1)). There is no evidence of competing aetiology. There is at least 1 coexisting or history of metabolic comorbidity.
- Historical biopsy showed steatosis (no steatohepatitis), and now diagnosed with cirrhosis through non-invasive tests or clinical criteria (see criterion (5)-1)). There is no evidence of competing aetiology. There are at least 2 coexisting metabolic comorbidities or history of metabolic comorbidities, including obesity and/or T2DM.
- In the absence of biopsy, MAFLD-related cirrhosis is defined based on the following criterias:
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- Cirrhosis is defined based on one of the following non-invasive tests(NITS): i: MRE ≥ 5kPa or VCTE-LSM ≥ 20kPa (when the patients with BMI ≥ 28kg/m2 , MRE ≥ 5kPa must also be met); ii:VCTE ≥15 kPa and <20 kPa and 1 of the following: MRE≥4.45kPa or Agile4≥0.565 or Platelets≤150,000/µL; iii: VCTE <15 kPa and 2 of the following: MRE≥4.45kPa or Agile4≥0.565 or Platelets≤150,000/µL; b. Current or previous imaging examinations have diagnosed fatty liver or controlled attenuation parameter (CAP)>288dB/m or magnetic resonance imaging proton density fat fraction (MRI-PDFF)>5%.
- There is no evidence of competing aetiology; d. There are at least 2 coexisting metabolic comorbidities or history of metabolic comorbidities, including obesity and/or T2DM.
- If a participant's MAFLD-related cirrhosis diagnosis for eligibility is based on the biopsy screening period , no weight loss of ≥10% should have occurred in the same time period (based on medical history).
Who cannot join
- Other chronic liver diseases (including but not limited to viral hepatitis, alcoholic liver disease, drug-induced liver injury, autoimmune liver disease, Wilson's disease, hemochromatosis, etc.)
- There has been a continuous history of heavy drinking for 3 months or more current or rencent 5 years (heavy drinking is defined as >20 g/day in women and >30 g/day in men); Or researchers can not reliably quantify alcohol consumption.
- Hepatic decompensation events (including ascites, esophageal and gastric variceal bleeding, hepatic encephalopathy, hepatorenal syndrome, spontaneous bacterial peritonitis, etc.) or hepatocellular carcinomaor.
- History of malignant tumors within 5 years (excluding local squamous cell carcinoma of the skin or treated cervical intraepithelial neoplasia)；
- Combination of autoimmune diseases (including but not limited to systemic lupus erythematosus, multiple sclerosis, Hashimoto's thyroiditis, etc.)；
- Combined with severe esophageal and gastric varices and/or positive red sign accessed by endoscope；
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- History of liver transplantation or bone marrow transplantationor or listed for liver transplantation;
- Previous (<5 years before screening)or planned (during the trial period) treatment for obesity with surgery;
- Have obesity induced by other endocrinologic disorders (i.e. Cushing Syndrome) genetic diseases;
- Secondary factors that can cause liver steatosis, such as malnutrition, medication, genetic metabolic diseases, etc.
- Individuals with the following abnormal indicators:
- Alanine aminotransferase (ALT)>5 * ULN;
- Aspartate aminotransferase (AST)>5 * ULN
- Direct bilirubin (DBIL)>1.5 * ULN
- Estimated glomerular filtration rate (eGFR)<60 mL/min/1.73m2
- Glycated hemoglobin (HbA1c)>10%
- MELD score ≥ 12 or Child Pugh score ≥ 8 caused by liver disease
- History of any type of diabetes than T2DM;
- Participants receive more than 1 month of treatment with any of the following drugs within 6 months before screening: thiazolidinedione (TZD), glucagon like peptide-1 (GLP-1) receptor agonists, bate lipid-lowing drugs, liver selective thyroxine receptor beta (TSH - β) agonists, obeticolic acid, insulin, berberine, weight-loss drugs, amiodarone, methotrexate, systemic glucocorticoids at >5 mg/day of prednisone equivalent, tamoxifen, oestrogens at doses higher than those used for hormone replacement or contraception, anabolic steroids except testosterone replacement, valproic acid, and known hepatotoxins;
- Participants receive the following medications unless they have received a stable dose of at least 1 month prior to screening: beta blockers, thiazide diuretics, statins, niacin, ezetimibe, thyroid hormones, metformin, dipeptidyl peptidase-4 (DPP-4) inhibitors, sodium glucose cotransporter (SGLT-2) inhibitors, sulfonylureas, gliptides, alpha glucosidase inhibitors;
- Participating in clinical trials of other drugs or medical devices within the past 3 months.
- Participants who demonstrate recent evidence (within 6 months prior to screening) of acute or unstable cardiovascular and cerebrovascular events events (such as hospitalisation for myocardial infarction, stroke, chronic heart failure grade IV (NYHA classification), severe arrhythmia, left ventricular hypertrophy, transient ischemic attack, and/or acute peripheral vascular events);
- QTc (Fridericia) mean interval that is greater than 500 ms at screening (triplicate electrocardiogram [ECG]) or personal or family history of long QT syndrome;
- Have a history of major surgery or fracture in the past 3 months;
- Severe osteoporosis or other known bone diseases, or other conditions that may lead to fractures accessed by researchers;
- History of lower limb or systemic edema;
- Contraindications for MRI scans, including but not limited to: cerebral aneurysm clips, implanted nerve stimulators, implanted pacemakers or defibrillators, or the presence of artificial heart valves, cochlear implants, potentially ferromagnetic intraocular foreign bodies (such as metal shavings), other implantable medical devices (such as insulin pumps), metal shrapnel or bullets remaining in the body, severe claustrophobia, tattoos (determined by the researcher and radiologist), weight exceeding the carrying capacity of the MRI scanner, etc.;
- Positive for human immunodeficiency virus (HIV) infection;
- History of drug use or abuse of drugs within the 12 months prior to screening.
- patients who have smoked heavily within the past year, with a daily intake of ≥ 30 cigarettes;
- Pregnant or lactating women, and the woman of childbearing age who are unable or unwilling to use adequate contraception;
- Researchers believe that patients who are not suitable to participate in this study.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Xiaofei Tong contact
China4 sites
Beijing Ditan Hospital, Capital Medical University
Beijing, China, 100015
Qi Wang, 01084322882, wangqidl04@ccmu.edu.cn
Peking University People's Hospital
Beijing, China, 100044
Xiaoxiao Wang, +86-1881178086, wangxx0635@163.com
Beijing Friendship Hospital, Capital Medical University
Beijing, China, 100050
Xiaofei Tong, 8601080839383, Tongxf@163.com
Beijing Youan Hospital, Capital Medical University
Beijing, China, 100069
Jing Zhang, +86-13391859683, zjyouan@ccmu.edu.cn
About this study
Official title: A Key Therapeutic System for Reversing MAFLD-related Cirrhosis: a Randomized Double-blind Controlled Trial on the Efficacy and Safety of Chiglitazar in Patients with MAFLD-related Cirrhosis
A total of 195 adult patients with biopsy-proven or clinically diagnosed metabolic dysfunction-associated with fatty liver disease(MAFLD)-related cirrhosis will be randomly divided into two arms. One arm will receive Chiglitazar(64 mg) treatment, while the other arm will receive placebo treatment, lasting for 72 weeks. Both the researchers and the participants will be blinded. The primary outcome is the reversal rate of cirrhosis assessed by magnetic resonance elastography. Secondary outcomes include outcome events, changes in histopathological fibrosis stage, non-invasive fibrosis tests, glucose and lipid metabolism indicators.
- Being tested
- Chiglitazar 64mg, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chiglitazar 64mgDrug
Chiglitazar 64mg, oral, qd, for 72 weeks
PlaceboDrug
Placebo, oral, qd, for 72 weeks
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Chiglitazar 64mg, oral, qd, for 72 weeks Receives: Drug: Chiglitazar 64mg |
| Control arm | Placebo comparator | Placebo, oral, qd, for 72 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibrosis regression rate
20% decline in magnetic resonance elastography(MRE)
Measured: 72 weeks
Secondary outcomes (12)
Cumulative incidence of outcomes events
Cumulative incidence of outcomes events(including liver decompensation, hepatocellular carcinoma, liver transplantation, and death)
Measured: 72 weeks
Percentage of participants acheving decline in fibrosis stage in histopathology
changes in fibrosis stage in histopathology
Measured: 72 weeks
Number of patients with decreased scores of non-invasive liver fibrosis tests
Dynamic change of non-invasive liver fibrosis tests(including APRI、FIB-4、FAST、NFS)
Measured: weeks 2, 4, 8, 12, 18, 24, 32, 40, 48, and 72.
Number of patients with decrease of MRE
absolute change of MRE, and percentage of patients achieving 15% decline in MRE
Measured: weeks 48, and 72.
Number of patients with change in magnetic resonance imaging-derived proton density fat fraction(MRI-PDFF))
absolute change in MRI-PDFF, and percentage of patients achieving 30% decline in MRI-PDFF
Measured: weeks 48, and 72.
Number of patients with decrease of liver stiffness measurement (LSM) via vibration-controlled transient elastography (VCTE)
Absolute change in LSM, CAP, and SSM, and percentage of patients achieving 30% decline in LSM
Measured: weeks12, 24, 48, and 72.
Number of patients with change in spleen stiffness measurement (SSM)) via vibration-controlled transient elastography (VCTE)
Measured: weeks12, 24, 48, and 72.
Number of patients with change in controlled attenuation parameter(CAP) via vibration-controlled transient elastography (VCTE)
Measured: weeks12, 24, 48, and 72.
Number of patients with decrease in glycosylated hemoglobin A1c (HbA1c)
Measured: weeks12, 24, 48, and 72.
Number of patients with change in lipidmetabolism indicators.
Dynamic changes in lipidmetabolism indicators (including triglycerides, total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, and apolipoprotein B (Apo B))
Measured: weeks 2, 4, 8, 12, 18, 24, 32, 40, 48, and 72.
Number of patients with change of liver function indictors
Dynamic change of liver function indicators (including ALT and AST)
Measured: weeks 2, 4, 8, 12, 18, 24, 32, 40, 48, and 72.
Number of patients with change in fast plasma glucose
Measured: weeks 2, 4, 8, 12, 18, 24, 32, 40, 48, and 72.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start5 Feb 2025 (estimated)
- Primary completion31 Jan 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Dysfunction Associated Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Beijing Friendship HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 195 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Ditan Hospital, Peking University People's Hospital, Beijing YouAn Hospital
- Responsible party
- Principal investigator, Hong You, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06773221
- Sponsor's protocol ID
- 2024-P2-487-01
- Status last verified
- Jan 2025
- First submitted
- 2 Jan 2025
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Key Therapeutic System for Reversing MAFLD-related Cirrhosis: a Randomized Double-blind Controlled Trial on the Efficacy and Safety of Chiglitazar in Patients with MAFLD-related Cirrhosis
- ClinicalTrials.gov ID
- NCT06773221
- Acronym / sponsor ID
- 2024-P2-487-01
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 195 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Collaborators
- Beijing Ditan Hospital, Peking University People's Hospital, Beijing YouAn Hospital
- Study start
- 5 Feb 2025 (estimated)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 14 Jan 2025 (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.
A total of 195 adult patients with biopsy-proven or clinically diagnosed metabolic dysfunction-associated with fatty liver disease(MAFLD)-related cirrhosis will be randomly divided into two arms. One arm will receive Chiglitazar(64 mg) treatment, while the other arm will receive placebo treatment, lasting for 72 weeks. Both the researchers and the participants will be blinded. The primary outcome is the reversal rate of cirrhosis assessed by magnetic resonance elastography. Secondary outcomes include outcome events, changes in histopathological fibrosis stage, non-invasive fibrosis tests, glucose and lipid metabolism indicators.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Drug: Chiglitazar 64mgChiglitazar 64mg, oral, qd, for 72 weeks |
| Control arm | Placebo comparator | Drug: PlaceboPlacebo, oral, qd, for 72 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. Men and women aged between 18 and 75 years (inclusive) who understand and sign informed consent forms; 2. Compensated MAFLD-related cirrhosis diagnosis(meet one of the following conditions):
- The liver biopsy during the screening period (liver biopsy within 6 months of screening is acceptable) showing cirrhosis with steatohepatitis according to the Non Alcoholic Fatty Liver Disease Clinical Research Network (NASH-CRN) scoring system, and there is no evidence of competitive aetiology.
- The liver biopsy during the screening period (liver biopsy within 6 months of screening is acceptable) showing cirrhosis with steatosis (no steatohepatitis) according to NASH-CRN scoring system, and there is no evidence of competitive aetiology. There are at least 2 coexisting metabolic comorbidities or history of metabolic comorbidities, including obesity and/or type 2 diabetes mellitus (T2DM).
- Historical biopsy showed steatohepatitis, and now diagnosed with cirrhosis through non-invasive tests or clinical criteria (see criterion (5)-1)). There is no evidence of competing aetiology. There is at least 1 coexisting or history of metabolic comorbidity.
- Historical biopsy showed steatosis (no steatohepatitis), and now diagnosed with cirrhosis through non-invasive tests or clinical criteria (see criterion (5)-1)). There is no evidence of competing aetiology. There are at least 2 coexisting metabolic comorbidities or history of metabolic comorbidities, including obesity and/or T2DM.
Key exclusion criteria (32 listed)
- Other chronic liver diseases (including but not limited to viral hepatitis, alcoholic liver disease, drug-induced liver injury, autoimmune liver disease, Wilson's disease, hemochromatosis, etc.)
- There has been a continuous history of heavy drinking for 3 months or more current or rencent 5 years (heavy drinking is defined as >20 g/day in women and >30 g/day in men); Or researchers can not reliably quantify alcohol consumption.
- Hepatic decompensation events (including ascites, esophageal and gastric variceal bleeding, hepatic encephalopathy, hepatorenal syndrome, spontaneous bacterial peritonitis, etc.) or hepatocellular carcinomaor.
- History of malignant tumors within 5 years (excluding local squamous cell carcinoma of the skin or treated cervical intraepithelial neoplasia)；
- Combination of autoimmune diseases (including but not limited to systemic lupus erythematosus, multiple sclerosis, Hashimoto's thyroiditis, etc.)；
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 |
|---|---|---|
| Chiglitazar 64mgChiglitazar 64mg, oral, qd, for 72 weeks | Drug | Treatment arm |
| PlaceboPlacebo, oral, qd, for 72 weeks | Drug | Control arm |
Primary outcome
Fibrosis regression rate
Time frame: 72 weeks
20% decline in magnetic resonance elastography(MRE)
12 secondary outcomes
Cumulative incidence of outcomes events
Time frame: 72 weeks
Percentage of participants acheving decline in fibrosis stage in histopathology
Time frame: 72 weeks
Number of patients with decreased scores of non-invasive liver fibrosis tests
Time frame: weeks 2, 4, 8, 12, 18, 24, 32, 40, 48, and 72.
Number of patients with decrease of MRE
Time frame: weeks 48, and 72.
Number of patients with change in magnetic resonance imaging-derived proton density fat fraction(MRI-PDFF))
Time frame: weeks 48, and 72.
Number of patients with decrease of liver stiffness measurement (LSM) via vibration-controlled transient elastography (VCTE)
Time frame: weeks12, 24, 48, and 72.
Number of patients with change in spleen stiffness measurement (SSM)) via vibration-controlled transient elastography (VCTE)
Time frame: weeks12, 24, 48, and 72.
Number of patients with change in controlled attenuation parameter(CAP) via vibration-controlled transient elastography (VCTE)
Time frame: weeks12, 24, 48, and 72.
Number of patients with decrease in glycosylated hemoglobin A1c (HbA1c)
Time frame: weeks12, 24, 48, and 72.
Number of patients with change in lipidmetabolism indicators.
Time frame: weeks 2, 4, 8, 12, 18, 24, 32, 40, 48, and 72.
Number of patients with change of liver function indictors
Time frame: weeks 2, 4, 8, 12, 18, 24, 32, 40, 48, and 72.
Number of patients with change in fast plasma glucose
Time frame: weeks 2, 4, 8, 12, 18, 24, 32, 40, 48, and 72.
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 15 Jan 2025.
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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.
Xiaofei Tong contact
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chiglitazar 64mg in people with Metabolic Dysfunction Associated Fatty Liver Disease and Compensated Liver Cirrhosis, run by Beijing Friendship Hospital at 4 sites 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 32 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: opening soon, as of the sponsor's last update on 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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.
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 Hong You (861063139019, youhong30@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fibrosis regression rate (time frame: 72 weeks). 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 15 Jan 2025.