Placenta extract injection aims to tame chronic liver disease
NCT ID NCT06493799
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This Phase 3 trial tests a drug called LAENNEC, made from human placenta, in people with chronic liver disease. It compares giving the drug as an intravenous drip versus a standard shot under the skin. The main goal is to see if the IV form lowers liver enzyme levels more effectively over 6 weeks. About 226 adults with alcoholic or non-alcoholic fatty liver disease and elevated ALT levels are being recruited.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- LAENNEC (human placenta hydrolysate)
- What this could lead to
- If successful, this could offer a new way to deliver LAENNEC intravenously to better manage chronic liver disease and reduce liver enzyme levels.
- What could go wrong
- This is a Phase 3 trial, but it compares two forms of the same drug, not against a placebo. The benefit over standard care is unclear, and long-term outcomes are not measured.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 226 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2024
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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19 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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GC wellbeing
RECRUITINGYongin-si, South Korea
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- Ketogenic diet vs mediterranean diet: which better reshapes metabolism?
- Can a simple scan reveal hidden liver damage in diabetes patients?