Metabolic Dysfunction-associated Fatty Liver DiseaseNCT07085962
Efficacy and Safety of Calculus Bovis Sativus in Adults With MAFLD
A study testing Calculus bovis sativus in people with Metabolic Dysfunction-associated Fatty Liver Disease, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
Metabolic dysfunction-associated fatty liver disease (MAFLD) has become the most common chronic liver disease worldwide. Timely therapeutic intervention for MAFLD is crucial for improving patient prognosis and preventing its progression to liver fibrosis, cirrhosis, and even hepatocellular carcinoma (HCC). 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
- What is being tested?
- Calculus bovis sativus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2025to 31 Jul 2026
- 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
- Has signed the informed consent form (ICF) prior to the study and is fully aware of the study's content, procedures, and potential adverse reactions.
- Is able to complete the study in accordance with the protocol requirements.
- The subject (and/or partner) agrees to use effective contraceptive measures voluntarily from the screening period until 6 months after the last dose of the investigational product.
- At the time of signing the ICF, age is between 18 and 75 years (inclusive), with no restriction on sex.
- Meets the diagnostic criteria outlined in the "Guidelines for the Prevention and Treatment of Metabolic Dysfunction-Associated (Non-alcoholic) Fatty Liver Disease (2024 Edition)" issued by the Chinese Society of Hepatology, Chinese Medical Association.
- Confirmed significant hepatic steatosis by transient elastography (Fibroscan) with a Controlled Attenuation Parameter (CAP) value ≥ 240 dB/m.
Show all 13Show fewer
- Liver enzyme levels meet the following criteria: 1 × upper limit of normal (ULN) < serum AST and ALT < 5 × ULN.
- Exclusion of significant liver fibrosis based on non-invasive assessment, meeting at least one of the following four conditions:
- FIB-4 < 1.3
- NAFLD Fibrosis Score (NFS) < -1.455
- LSM < 8.0 kPa
- FAST score < 0.35
- Stable body weight for at least 6 weeks prior to screening, defined as a weight change (increase or decrease) of ≤5%.
Who cannot join
- Presence of the following chronic diseases: viral hepatitis; positive serology for Human Immunodeficiency Virus (HIV); primary sclerosing cholangitis, primary biliary cholangitis, autoimmune hepatitis, drug-induced liver disease, alcoholic liver disease, or Wilson's disease.
- Excessive alcohol consumption (defined as >30g of alcohol per day for males or >20g per day for females).
- History of diabetes other than type 2 diabetes, such as type 1 diabetes, secondary diabetes, etc.
- History of malignancy (except for those with a tumor-free period of more than 5 years prior to screening), or currently under evaluation for active or suspected malignancy. Exceptions include fully treated basal cell carcinoma, squamous cell skin carcinoma, or cervical carcinoma in situ.
- History of bariatric surgery within the 5 years prior to screening (inclusive).
- Use of antibiotics within the last 3 weeks or during the study period.
Show all 23Show fewer
- Underwent major surgery within 3 months prior to signing the ICF, or planning to undergo major surgery during the study period. (Major surgery is defined as a procedure with risk to the patient's life, particularly surgery involving the cranium, chest, abdomen, or pelvic organs).
- Recent history of drug abuse (defined as ≤2 years).
- Presence of psychosis or any other cognitive impairment, or other conditions that would interfere with the subject's compliance.
- Currently receiving any approved therapy for MASH. Receiving anticoagulant therapy (e.g., warfarin, heparin), or participated in another interventional clinical trial with a drug product within 3 months prior to screening.
- Presence of any of the following laboratory exclusion criteria at screening (the study center may repeat the test once for any abnormal value):
- Serum ALT or AST > 5 × ULN
- Alkaline phosphatase (ALP) ≥ 2 × ULN
- eGFR < 60 mL/min
- Total bilirubin > 1.5 × ULN
- Platelet count < lower limit of normal (LLN)
- Received a blood transfusion within ≤2 months prior to screening and/or donated blood within ≤1 month prior to screening. Note: Subjects are not permitted to donate blood throughout the entire study period.
- Presence of portal hypertension, such as esophageal varices, ascites, or hepatic encephalopathy.
- Pregnant or lactating females.
- History of liver transplantation or planned liver transplantation.
- Presence of any significant systemic or major diseases other than liver disease, including recent (≤6 months prior to screening) congestive heart failure (New York Heart Association [NYHA] Functional Classification III-IV), unstable coronary artery disease, arterial revascularization, respiratory disease, renal failure, stroke, transient ischemic attack, organ transplant, psychiatric disorders, or any other clinically significant disease-related event requiring hospitalization within 6 months prior to screening.
- Acute or chronic gastrointestinal diseases (including diarrhea, gastrointestinal infections, inflammatory bowel disease, etc.).
- Any condition that, in the opinion of the investigator, would pose a safety risk to the subject or may interfere with the conduct of the study, or if the investigator believes the subject is unlikely to complete the study or comply with its requirements.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Tongji Hospital, Tongji Medical College, HUST
Wuhan, Hubei, 430030
Bin Cheng, Doctor, 027-83663334, bcheng@tjh.tjmu.edu.cn
Jiamei Jiang, 86-15727444292, jiangjiamei@hust.edu.cn
About this study
Official title: A Randomized, Controlled Study to Evaluate the Efficacy and Safety of Calculus Bovis Sativus in Adult Subjects With Metabolic Dysfunction-associated Fatty Liver Disease (MAFLD)
Metabolic dysfunction-associated fatty liver disease (MAFLD) has become the most common chronic liver disease worldwide. Timely therapeutic intervention for MAFLD is crucial for improving patient prognosis and preventing its progression to liver fibrosis, cirrhosis, and even hepatocellular carcinoma (HCC). Therefore, the discovery of novel drugs for the treatment of MAFLD is of great significance.
Previous clinical studies have shown that calculus bovis sativus, as an adjuvant therapy for icteric hepatitis and chronic hepatitis B, exhibits significant anti-inflammatory and enzyme-reducing effects, improves liver function indicators, and enhances overall clinical outcomes. However, there is currently no clinical research on the therapeutic effects of calculus bovis sativus in patients with MAFLD, and its underlying mechanisms of action remain to be elucidated.
This study proposes a randomized, double-blind, placebo-controlled trial to investigate the effects of calculus bovis sativus in adult patients with MAFLD. The primary objective is to preliminarily explore the clinical efficacy of calculus bovis sativus in treating MAFLD, particularly its impact on liver injury and inflammation. Furthermore, this research will employ a multi-omics approach, integrating metagenomics and metabolomics, to analyze the effects of calculus bovis sativus on the gut microbiota and their metabolites in MAFLD patients. The aim is to uncover its potential mechanisms of action, thereby facilitating its clinical translation and application, and ultimately providing a new therapeutic strategy for patients with MAFLD.
Read the detailed description
This study is designed as a randomized, double-blind, placebo-controlled trial to investigate calculus bovis sativus in adult subjects with metabolic dysfunction-associated fatty liver disease (MAFLD). The study aims to evaluate the safety of calculus bovis sativus in subjects with MAFLD by monitoring the incidence of adverse events and key laboratory parameters, including routine blood and urine tests, as well as hepatic and renal function, and to preliminarily investigate the potential clinical efficacy of calculus bovis sativus in mitigating MAFLD, liver injury, and inflammation by monitoring various serum biomarkers and non-invasive assessment parameters, such as the controlled attenuation parameter (CAP), liver stiffness measurement (LSM), and magnetic resonance imaging proton density fat fraction (MRI-PDFF). Furthermore, this study will employ a multi-omics approach, combining metagenomics and metabolomics, to explore the effects of calculus bovis sativus on the gut microbiota and its metabolites in patients with MAFLD.
- Being tested
- Calculus bovis sativus, Placebo
- Keywords
- metabolic dysfunction-associated fatty liver disease, Calculus bovis sativus, Hypertransaminasemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calculus bovis sativusDrug
Calculus bovis sativus 200mg qd
PlaceboDrug
Placebo 200mg qd
| Study group | Role | What they receive |
|---|---|---|
| Calculus bovis sativus group | Experimental | Participants will receive Calculus bovis sativus 200mg orally, once daily (qd) for 12 weeks. Receives: Drug: Calculus bovis sativus |
| placebo group | Placebo comparator | Participants will receive placebo matched in appearance, taste, and smell to the active drug, orally, once daily (qd) for 12 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Alanine Aminotransferase (ALT) at Week 12
Alanine Aminotransferase (ALT) will be measured from serum samples. The result will be reported in international units per liter (U/L).
Measured: At baseline and after 4 weeks,8 weeks and 12 weeks of treatment
Secondary outcomes (26)
Change from Baseline in Aspartate Aminotransferase (AST) at Week 12
Aspartate Aminotransferase (AST) will be measured from serum samples. The result will be reported in international units per liter (U/L).
Measured: Baseline, Week 4, Week 8, and Week 12
Change from Baseline in Gamma-glutamyl Transferase (GGT) at Week 12
Gamma-glutamyl Transferase (GGT) will be measured from serum samples. The result will be reported in international units per liter (U/L).
Measured: At baseline and after 4 weeks,8 weeks and 12 weeks of treatment
Change from Baseline in Total Bilirubin at Week 12
Total Bilirubin will be measured from serum samples. The result will be reported in micromoles per liter (μmol/L).
Measured: At baseline and after 4 weeks,8 weeks and 12 weeks of treatment
Change from Baseline in Alkaline Phosphatase (ALP) at Week 12
Alkaline Phosphatase (ALP) will be measured from serum samples. The result will be reported in international units per liter (U/L).
Measured: At baseline and after 4 weeks,8 weeks and 12 weeks of treatment
Change from Baseline in Liver Stiffness Measurement (LSM) by Fibroscan at Week 12
Liver Stiffness Measurement (LSM) is assessed using Fibroscan to evaluate liver fibrosis. The result is reported in kilopascals (kPa).
Measured: At baseline and after 12 weeks of treatment
Change from Baseline in Controlled Attenuation Parameter (CAP) by Fibroscan at Week 12
Controlled Attenuation Parameter (CAP) is assessed using Fibroscan to quantify liver steatosis (fat content). The result is reported in decibels per meter (dB/m).
Measured: At baseline and after 12 weeks of treatment
Change from Baseline in Body Weight at Week 12
Body weight will be measured in kilograms (kg).
Measured: At baseline and after 12 weeks of treatment
Change from Baseline in Body Mass Index (BMI) at Week 12
Body Mass Index (BMI) is calculated as weight in kilograms divided by the square of height in meters (kg/m²).
Measured: At baseline and after 12 weeks of treatment
Change from Baseline in Waist Circumference at Week 12
Waist circumference will be measured in centimeters (cm).
Measured: At baseline and after 12 weeks of treatment
Change from Baseline in Hip Circumference at Week 12
Hip circumference will be measured in centimeters (cm)
Measured: At baseline and after 12 weeks of treatment
Change from Baseline in Fasting Blood Glucose (FBG) at Week 12
Fasting Blood Glucose (FBG) will be measured from plasma samples. The result will be reported in millimoles per liter (mmol/L).
Measured: At baseline and after 12 weeks of treatment
Change from Baseline in Glycated Hemoglobin (HbA1c) at Week 12
Glycated Hemoglobin (HbA1c) will be measured from whole blood samples. The result will be reported as a percentage (%)
Measured: At baseline and after 12 weeks of treatment
Change from Baseline in Fasting Insulin at Week 12
Fasting insulin will be measured from serum samples. The result will be reported in micro-international units per milliliter (μIU/mL).
Measured: At baseline and after 12 weeks of treatment
Change from Baseline in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) at Week 12
The Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) is a calculated index based on fasting glucose and fasting insulin. It is calculated using the formula: [Fasting Insulin (μIU/mL) x Fasting Glucose (mmol/L)] / 22.5.
Measured: At baseline and after 12 weeks of treatment
Change from Baseline in Total Cholesterol (TC) at Week 12
Total Cholesterol (TC) will be measured from serum samples. The result will be reported in millimoles per liter (mmol/L).
Measured: At baseline and after 12 weeks of treatment
Change from Baseline in Triglycerides (TG) at Week 12
Triglycerides (TG) will be measured from serum samples. The result will be reported in millimoles per liter (mmol/L).
Measured: At baseline and after 12 weeks of treatment
Change from Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at Week 12
High-Density Lipoprotein Cholesterol (HDL-C) will be measured from serum samples. The result will be reported in millimoles per liter (mmol/L).
Measured: At baseline and after 12 weeks of treatment
Change from Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12
Low-Density Lipoprotein Cholesterol (LDL-C) will be measured from serum samples. The result will be reported in millimoles per liter (mmol/L).
Measured: At baseline and after 12 weeks of treatment
Change from Baseline in Liver Fat Fraction as Measured by MRI-PDFF at Week 12
Liver fat fraction will be quantified using Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF)
Measured: At baseline and after 12 weeks of treatment
Change from Baseline in Gut Microbiota Alpha Diversity as Measured by the Shannon Index at Week 12
Gut microbiota composition will be analyzed from stool samples using 16S rRNA sequencing. Alpha diversity, a measure of within-sample microbial richness and evenness, will be calculated using the Shannon index.
Measured: At baseline and after 12 weeks of treatment
Change from Baseline in Fecal Short-Chain Fatty Acid (SCFA) Concentrations at Week 12
Concentrations of key Short-Chain Fatty Acids (SCFAs), such as butyrate and propionate, will be quantified from stool samples using mass spectrometry-based metabolomics.
Measured: At baseline and after 12 weeks of treatment
Change from Baseline in Serum Total Bile Acid (TBA) Concentration at Week 12
Serum Total Bile Acid (TBA) concentration will be quantified using mass spectrometry-based metabolomics.
Measured: At baseline and after 12 weeks of treatment
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) as Graded by CTCAE v6.0
A Treatment-Emergent Adverse Event (TEAE) is defined as any adverse event occurring or worsening on or after the first dose of the study drug up to the final study visit at Week 12. The severity of all TEAEs will be graded using the Common Terminology Criteria for Adverse Events (CTCAE) v6.0.
Measured: From Baseline up to Week 12
Change from Baseline in Platelet Count at Week 12
Platelet count will be measured from a whole blood sample as part of routine safety monitoring. The result will be reported in gigaparticles per liter (x10^9/L).
Measured: At baseline and after 4 weeks,8 weeks and 12 weeks of treatment
Change from Baseline in Serum Creatinine at Week 12
Serum creatinine will be measured from a blood sample as part of routine safety monitoring. The result will be reported in micromoles per liter (μmol/L).
Measured: At baseline and after 4 weeks,8 weeks and 12 weeks of treatment
Change from Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 12
The Estimated Glomerular Filtration Rate (eGFR) is calculated based on serum creatinine, age, and sex, using the CKD-EPI 2021 equation. It is a key indicator of kidney function, reported in mL/min/1.73 m².
Measured: At baseline and after 4 weeks,8 weeks and 12 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start1 Aug 2025 (estimated)
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Jul 2026 (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 Huazhong University of Science and TechnologyThe 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bin Cheng, Huazhong University of Science and Technology
- Investigators
- Bin Cheng, Doctor, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07085962
- Sponsor's protocol ID
- CBS-MAFLD-2025
- Status last verified
- Jul 2025
- First submitted
- 12 Jun 2025
- Last updated
- 25 Jul 2025
- Results posted
- 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 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Study to Evaluate the Efficacy and Safety of Calculus Bovis Sativus in Adult Subjects With Metabolic Dysfunction-associated Fatty Liver Disease (MAFLD)
- ClinicalTrials.gov ID
- NCT07085962
- Acronym / sponsor ID
- CBS-MAFLD-2025
- Keywords
- metabolic dysfunction-associated fatty liver disease, Calculus bovis sativus, Hypertransaminasemia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 25 Jul 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.
Metabolic dysfunction-associated fatty liver disease (MAFLD) has become the most common chronic liver disease worldwide. Timely therapeutic intervention for MAFLD is crucial for improving patient prognosis and preventing its progression to liver fibrosis, cirrhosis, and even hepatocellular carcinoma (HCC). Therefore, the discovery of novel drugs for the treatment of MAFLD is of great significance.
Previous clinical studies have shown that calculus bovis sativus, as an adjuvant therapy for icteric hepatitis and chronic hepatitis B, exhibits significant anti-inflammatory and enzyme-reducing effects, improves liver function indicators, and enhances overall clinical outcomes. However, there is currently no clinical research on the therapeutic effects of calculus bovis sativus in patients with MAFLD, and its underlying mechanisms of action remain to be elucidated.
This study proposes a randomized, double-blind, placebo-controlled trial to investigate the effects of calculus bovis sativus in adult patients with MAFLD. The primary objective is to preliminarily explore the clinical efficacy of calculus bovis sativus in treating MAFLD, particularly its impact on liver injury and inflammation. Furthermore, this research will employ a multi-omics approach, integrating metagenomics and metabolomics, to analyze the effects of calculus bovis sativus on the gut microbiota and their metabolites in MAFLD patients. The aim is to uncover its potential mechanisms of action, thereby facilitating its clinical translation and application, and ultimately providing a new therapeutic strategy for patients with MAFLD.
Detailed description
This study is designed as a randomized, double-blind, placebo-controlled trial to investigate calculus bovis sativus in adult subjects with metabolic dysfunction-associated fatty liver disease (MAFLD). The study aims to evaluate the safety of calculus bovis sativus in subjects with MAFLD by monitoring the incidence of adverse events and key laboratory parameters, including routine blood and urine tests, as well as hepatic and renal function, and to preliminarily investigate the potential clinical efficacy of calculus bovis sativus in mitigating MAFLD, liver injury, and inflammation by monitoring various serum biomarkers and non-invasive assessment parameters, such as the controlled attenuation parameter (CAP), liver stiffness measurement (LSM), and magnetic resonance imaging proton density fat fraction (MRI-PDFF). Furthermore, this study will employ a multi-omics approach, combining metagenomics and metabolomics, to explore the effects of calculus bovis sativus on the gut microbiota and its metabolites in patients with MAFLD.
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 |
|---|---|---|
| Calculus bovis sativus group | Experimental | Drug: Calculus bovis sativusParticipants will receive Calculus bovis sativus 200mg orally, once daily (qd) for 12 weeks. |
| placebo group | Placebo comparator | Drug: PlaceboParticipants will receive placebo matched in appearance, taste, and smell to the active drug, orally, once daily (qd) 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 (13 listed)
- Has signed the informed consent form (ICF) prior to the study and is fully aware of the study's content, procedures, and potential adverse reactions.
- Is able to complete the study in accordance with the protocol requirements.
- The subject (and/or partner) agrees to use effective contraceptive measures voluntarily from the screening period until 6 months after the last dose of the investigational product.
- At the time of signing the ICF, age is between 18 and 75 years (inclusive), with no restriction on sex.
- Meets the diagnostic criteria outlined in the "Guidelines for the Prevention and Treatment of Metabolic Dysfunction-Associated (Non-alcoholic) Fatty Liver Disease (2024 Edition)" issued by the Chinese Society of Hepatology, Chinese Medical Association.
Key exclusion criteria (23 listed)
- Presence of the following chronic diseases: viral hepatitis; positive serology for Human Immunodeficiency Virus (HIV); primary sclerosing cholangitis, primary biliary cholangitis, autoimmune hepatitis, drug-induced liver disease, alcoholic liver disease, or Wilson's disease.
- Excessive alcohol consumption (defined as >30g of alcohol per day for males or >20g per day for females).
- History of diabetes other than type 2 diabetes, such as type 1 diabetes, secondary diabetes, etc.
- History of malignancy (except for those with a tumor-free period of more than 5 years prior to screening), or currently under evaluation for active or suspected malignancy. Exceptions include fully treated basal cell carcinoma, squamous cell skin carcinoma, or cervical carcinoma in situ.
- History of bariatric surgery within the 5 years prior to screening (inclusive).
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 |
|---|---|---|
| Calculus bovis sativusCalculus bovis sativus 200mg qd | Drug | Calculus bovis sativus group |
| PlaceboPlacebo 200mg qd | Drug | placebo group |
Primary outcome
Change from Baseline in Alanine Aminotransferase (ALT) at Week 12
Time frame: At baseline and after 4 weeks,8 weeks and 12 weeks of treatment
Alanine Aminotransferase (ALT) will be measured from serum samples. The result will be reported in international units per liter (U/L).
26 secondary outcomes
Change from Baseline in Aspartate Aminotransferase (AST) at Week 12
Time frame: Baseline, Week 4, Week 8, and Week 12
Change from Baseline in Gamma-glutamyl Transferase (GGT) at Week 12
Time frame: At baseline and after 4 weeks,8 weeks and 12 weeks of treatment
Change from Baseline in Total Bilirubin at Week 12
Time frame: At baseline and after 4 weeks,8 weeks and 12 weeks of treatment
Change from Baseline in Alkaline Phosphatase (ALP) at Week 12
Time frame: At baseline and after 4 weeks,8 weeks and 12 weeks of treatment
Change from Baseline in Liver Stiffness Measurement (LSM) by Fibroscan at Week 12
Time frame: At baseline and after 12 weeks of treatment
Change from Baseline in Controlled Attenuation Parameter (CAP) by Fibroscan at Week 12
Time frame: At baseline and after 12 weeks of treatment
Change from Baseline in Body Weight at Week 12
Time frame: At baseline and after 12 weeks of treatment
Change from Baseline in Body Mass Index (BMI) at Week 12
Time frame: At baseline and after 12 weeks of treatment
Change from Baseline in Waist Circumference at Week 12
Time frame: At baseline and after 12 weeks of treatment
Change from Baseline in Hip Circumference at Week 12
Time frame: At baseline and after 12 weeks of treatment
Change from Baseline in Fasting Blood Glucose (FBG) at Week 12
Time frame: At baseline and after 12 weeks of treatment
Change from Baseline in Glycated Hemoglobin (HbA1c) at Week 12
Time frame: At baseline and after 12 weeks of treatment
Change from Baseline in Fasting Insulin at Week 12
Time frame: At baseline and after 12 weeks of treatment
Change from Baseline in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) at Week 12
Time frame: At baseline and after 12 weeks of treatment
Change from Baseline in Total Cholesterol (TC) at Week 12
Time frame: At baseline and after 12 weeks of treatment
Change from Baseline in Triglycerides (TG) at Week 12
Time frame: At baseline and after 12 weeks of treatment
Change from Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at Week 12
Time frame: At baseline and after 12 weeks of treatment
Change from Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12
Time frame: At baseline and after 12 weeks of treatment
Change from Baseline in Liver Fat Fraction as Measured by MRI-PDFF at Week 12
Time frame: At baseline and after 12 weeks of treatment
Change from Baseline in Gut Microbiota Alpha Diversity as Measured by the Shannon Index at Week 12
Time frame: At baseline and after 12 weeks of treatment
Change from Baseline in Fecal Short-Chain Fatty Acid (SCFA) Concentrations at Week 12
Time frame: At baseline and after 12 weeks of treatment
Change from Baseline in Serum Total Bile Acid (TBA) Concentration at Week 12
Time frame: At baseline and after 12 weeks of treatment
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) as Graded by CTCAE v6.0
Time frame: From Baseline up to Week 12
Change from Baseline in Platelet Count at Week 12
Time frame: At baseline and after 4 weeks,8 weeks and 12 weeks of treatment
Change from Baseline in Serum Creatinine at Week 12
Time frame: At baseline and after 4 weeks,8 weeks and 12 weeks of treatment
Change from Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 12
Time frame: At baseline and after 4 weeks,8 weeks and 12 weeks of treatment
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 25 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Metabolic Dysfunction-associated Fatty Liver Disease
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
RecruitingPhase 3
A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
NASH With Fibrosis, MASH With Fibrosis
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
RecruitingPhase 1
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
Non-alcoholic Fatty Liver Disease
RecruitingPhase 3
A Pivotal Clinical Study to Investigate the Safety and Efficacy of Efimosfermin Compared With Placebo in Adult Participants With Compensated Cirrhosis Due to Metabolic Dysfunction-associated Steatohepatitis (MASH)
Metabolic Dysfunction-associated Steatohepatitis
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.
Bin Cheng, Doctor principal investigator
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calculus bovis sativus in people with Metabolic Dysfunction-associated Fatty Liver Disease, run by Huazhong University of Science and Technology 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 13 inclusion and 23 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 25 Jul 2025. 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.
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 Bin Cheng, Doctor (027-83663334, bcheng@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Alanine Aminotransferase (ALT) at Week 12 (time frame: At baseline and after 4 weeks,8 weeks and 12 weeks of treatment). 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 25 Jul 2025.