Efficacy and Safety of Calculus Bovis Sativus in Adults With MAFLD

NCT07085962 | Not Yet Recruiting

• 1 other identifier: CBS-MAFLD-2025
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Metabolic Dysfunction-associated Fatty Liver Disease

Keywords

metabolic dysfunction-associated fatty liver disease; Calculus bovis sativus; Hypertransaminasemia

Outcome Measures

Primary Outcomes (1)

• 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).

  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

  Baseline, Week 4, Week 8, and Week 12

• Change from Baseline in Gamma-glutamyl Transferase (GGT) at Week 12

  At baseline and after 4 weeks,8 weeks and 12 weeks of treatment

• Change from Baseline in Total Bilirubin at Week 12

  At baseline and after 4 weeks,8 weeks and 12 weeks of treatment

• Change from Baseline in Alkaline Phosphatase (ALP) at Week 12

  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

  At baseline and after 12 weeks of treatment

Study Arms (2)

Calculus bovis sativus group

EXPERIMENTAL

Participants will receive Calculus bovis sativus 200mg orally, once daily (qd) for 12 weeks.

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.

Drug: Placebo

Interventions

Calculus bovis sativus DRUG

Calculus bovis sativus 200mg qd

Calculus bovis sativus group

Placebo DRUG

Placebo 200mg qd

placebo group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Liver enzyme levels meet the following criteria: 1 × upper limit of normal (ULN) \< serum AST and ALT \< 5 × ULN.
• 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%.

You may not qualify if:

• 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.
• 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.
• 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)

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead

Study Sites (1)

Tongji Hospital, Tongji Medical College, HUST

Wuhan, Hubei, 430030, China

Location

Study Officials

• Bin Cheng, Doctor

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bin Cheng, Doctor

CONTACT

027-83663334; bcheng@tjh.tjmu.edu.cn

Jiamei Jiang

CONTACT

86-15727444292; jiangjiamei@hust.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 12, 2025
• First Posted: July 25, 2025
• Study Start: August 1, 2025
• Primary Completion: March 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)