Evaluating a treatment for metabolic-associated fatty liver disease

Evaluation of the Effectiveness of the Use of a Carnitine-Orotate Complex and Biphenyl Dimethyl Dicarboxylate in the Pathogenetic Therapy of Metabolic-associated Fatty Liver Disease: a Prospective Cohort Study

This study is testing if a combination of two treatments can help adults with metabolic-associated fatty liver disease feel better and improve their health.

Quick facts

• Study type: Observational
• Enrollment: 264 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Kazakh Association of Internal Medicine Specialists (other)
• Locations: 7 sites (Esik, Almaty Region and 6 other locations)
• Trial ID: NCT06078722 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the effectiveness and safety of a combination of Carnitine-Orotate Complex and Biphenyl Dimethyl Dicarboxylate in treating metabolic-associated fatty liver disease (MAFLD). It will involve patients aged 18 to 75 years with a confirmed diagnosis of MAFLD, who are not undergoing other adjuvant therapies. Participants will be monitored for their response to the treatment over a specified period, with a focus on both clinical and laboratory outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with a confirmed diagnosis of MAFLD and no severe concomitant diseases.

Not a fit: Patients with diabetes mellitus, severe liver conditions, or those currently abusing alcohol may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from metabolic-associated fatty liver disease.

How similar studies have performed: While this approach is novel, similar studies have shown promise in treating liver diseases with metabolic therapies.

Eligibility criteria

Inclusion Criteria:

* Patients of both sexes aged 18 to 75 years, who are citizens of the Republic of Kazakhstan;
* Patients with a clinically and laboratory confirmed diagnosis of MAFLD, without severe concomitant diseases;
* Patients who do not receive other adjuvant therapy (metabolic therapy drugs, essential phospholipids, ursodeoxycholic acid, glycyrrhizic acid, ademetionine and others);
* Patients who have at least a 7-day gap between the end of other adjuvant therapy and the start of COC and BDD;
* Patients who voluntarily signed the informed consent form.

Exclusion Criteria:

* Patients who abuse alcohol according to the AUDIT-c questionnaire;
* Patients taking COC for more than 4 weeks before signing the informed consent;
* Patients with contraindications to COC;
* Patients diagnosed with diabetes mellitus;
* Pregnancy and lactation;
* Simultaneous use of levodopa, altretamine, cisplatin, statins;
* Patients with coinfection with HIV, HBV, HCV;
* Decompensated liver cirrhosis CPT≥7 points;
* GFR ≤ 15 ml/min/1.73 m2;
* Drug-induced liver damage;
* Taking narcotic and psychotropic drugs;
* Malignant formations of the liver and other organs (in history and currently) or a clinically significant increase in alpha-fetoprotein more than \>5 times;
* patients with pronounced biochemical activity (ALT, AST more than 10 ULN) and total bilirubin more than 2 ULN;
* Participation in an interventional clinical trial.

Where this trial is running

Esik, Almaty Region and 6 other locations

• State-owned public enterprise with the right of economic management "Enbekshikazakh Interdistrict Multidisciplinary Hospital" — Esik, Almaty Region, Kazakhstan (RECRUITING)
• LLP "InkarMed" — Aktobe, Kazakhstan (RECRUITING)
• hepatology center on the basis of the State Public Enterprise at the RV "City Clinic No. 5" — Almaty, Kazakhstan (RECRUITING)
• Medical Center "iClinic" — Astana, Kazakhstan (RECRUITING)
• Non-profit joint-stock company "Semey Medical University" — Semey, Kazakhstan (RECRUITING)
• Medical center "Gatromed" — Shymkent, Kazakhstan (RECRUITING)
• State-owned public enterprise with the right of economic management "Regional Clinical Hospital" of the Department of Public Health of the Turkestan region — Turkestan, Kazakhstan (RECRUITING)

Study contacts

• Study coordinator: Aigul Dzhumabaeva

Conditions: Metabolic-associated Fatty Liver Disease