Comparing intravenous and under-skin LAENNEC for alcoholic and non-alcoholic fatty liver disease

A Multicenter, Randomized, Open-label, Active-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous Drop of 'LAENNEC INJ. (Human Placenta Hydrolysate) Compared With Subcutaneous Injection in Patients With Chronic Liver Disease

This will test whether 10 ml intravenous LAENNEC given twice weekly for six weeks works better and is as safe as 4 ml subcutaneous LAENNEC in adults 19–70 with alcoholic or non‑alcoholic fatty liver disease.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 226 (estimated)
• Ages: 19 Years to 70 Years
• Sex: All
• Sponsor: Green Cross Wellbeing (Industry-sponsored)
• Locations: 1 site (Yongin-si)
• Trial ID: NCT06493799 on ClinicalTrials.gov

What this trial studies

This randomized, open-label, active-controlled Phase 3 trial will enroll 226 adults with chronic liver disease (alcoholic or non-alcoholic fatty liver disease) and elevated ALT. Participants are randomized 1:1 to receive either 4 ml subcutaneous LAENNEC or 10 ml intravenous LAENNEC twice weekly for six weeks, with an ALD:NAFLD ratio of about 1:3 within each arm. Safety, tolerability, and efficacy are assessed at baseline and at follow-up visits on weeks 2, 4, and 6. The trial compares clinical and laboratory liver outcomes and adverse events between the two administration routes.

Who should consider this trial

Good fit: Adults aged 19–70 with a diagnosis of alcoholic or non-alcoholic fatty liver disease and an ALT between 60 and 200 IU/L who can comply with study visits are the intended participants.

Not a fit: Patients with recent liver cancer, decompensated cirrhosis (Child-Pugh B or C), prior organ or bone marrow transplant, biliary atresia, genetic metabolic liver disease, fulminant hepatic failure, or other listed exclusion conditions are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, the intravenous formulation could offer a more effective or faster-acting option to improve liver enzymes and symptoms for patients with ALD or NAFLD.

How similar studies have performed: Small prior studies and clinical use of placenta-derived hydrolysates suggest possible benefit, but robust phase 3 evidence is limited.

Eligibility criteria

Inclusion Criteria:

A participant will be eligible for participation in the trial if all of the following inclusion criteria are met:

1. At the time of screening, 19 or 70 years
2. Those who have been diagnosed with alcoholic or non-alcoholic fatty liver disease
3. Those who have increased ALT level (Increased ALT level : 60 IU/L ≤ ALT ≤ 200 IU/L)
4. A person who can complete the signature agreement and comply with clinical trial requirements.

Exclusion Criteria:

A participant will not be eligible for trial participation if any of the following exclusion criteria are met:

1. If you have the following disease

   * Liver cancer or other malignant tumor within 5 years at screening point
   * Esophageal varix bleeding, hepatic coma, ascites etc. related disease or Child-Pugh Score Class B,C patient within 1 year at screening point
   * Organs or bone marrow transplant experience
   * Billiary atresia, Genetic metabolic liver disease, Fulminant Hepatic failure, toxicity or Clinically diagnosed hepatitis, bleeding or Platelet disease patient
   * Autoimmune hepatitis, Primary biliary cirrhosis, Sclerosing cholangitis, IgG4- associated cholangitis patient
   * Bariatric Surgery within 24 weeks at screening point
   * Uncontrolled diabetes mellitus (HBA1c \> 9.0%)
   * Uncontrolled serious Cardiopulmonary disease
   * Liver cancer or other malignant tumor within 5 years at screening point
   * Those who have alcohol abuse within 5 years at screening point
   * Hepatitis B, C virus (However, those who have been identified as HBV DNA undetectable or SVR after antiviral administration can participate)
   * Systemic infection (including tuberculosis)
2. If you are taking the following drug (Hepatotonics)

   * However, it is possible to register after having a drug holiday

     * Biphenyl dimethyl dicarboxylate (BDD), Silymarin(Milk thistle) : 14 days
     * Ursodeoxycholic acid (UDCA) : 30 days
     * Other Hepatotonics : 5 times half-life
3. If you are taking the following drug or need to take drugs during the clinical trial period

   * Antituberculous drug(Isoniazid, Rifampin etc.), antifungal agent and antibiotic
   * Acetaminophen, NSAIDs(Excluding low-dose aspirin for preventive purposes)
   * Lipid lowering agent(Niacin etc.) and Oral hypoglycemic agent(acarbose etc.) (Registered when administered during the clinical trial period with a certain dose without a change in dose currently being taken)
   * Antiseric agent (ARB, Beta-blocker, CCB etc.) (Registered when administered during the clinical trial period with a certain dose without a change in dose currently being taken)
   * Vitamin E (Purpose of treatment of more than 800 IU/day)
   * Astrogens
   * Systemic corticosteroids, Immunomodulator
4. If you take more alcohol than the recommended amount (Man 40 g/day, Woman 20 g/day)
5. Drug allergic symptoms (oscillation, heat, itching)
6. Those who have received other clinical drugs within 4 weeks before selecting a test subject
7. Those who cannot inject intravenous infusions (5% Dextrose Inj.)
8. A person who does not perform appropriate contraception as a pregnant woman, a nursing or a woman of childbearing age (effective contraception method: Barrier methods using infertility surgery, uterine device, condom, killer)
9. Those who judged that other testors were inappropriate as clinical trials

Where this trial is running

Yongin-si

• GC wellbeing — Yongin-si, South Korea (Recruiting)

Study contacts

• Study coordinator: Yeongmin Kwon

Conditions Chronic Liver Disease