Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SAMe · 1 trial · 1 indication
After the methionine load, blood samples will be obtained at 0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours. Plasma will be analyzed for methionine.
| Arm | Type | Description |
|---|---|---|
| 1000 mg SAMe (S-adenosyl-L-methionine) | EXPERIMENTAL | - |
| 1500 mg SAMe | EXPERIMENTAL | - |
| 2000 mg SAMe | EXPERIMENTAL | - |
| No treatment | NO_INTERVENTION | - |
| Name | Type | Description |
|---|---|---|
| SAMe 1000 mg | DRUG | 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner |
| SAMe 1500 mg | DRUG | 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner |
| SAMe 2000 mg | DRUG | 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner |
Inclusion Criteria * Subjects with non-alcoholic steatohepatitis based on histology in medical history within the last 3 years * Subjects in a stable metabolic condition since histology for NASH (Non-alcoholic Steatohepatitis) Exclusion Criteria * Subjects with extrahepatic biliary obstruction * ...
SAMe, also known as S-adenosyl-L-methionine, is being investigated for the treatment of Non Alcoholic Fatty Liver Disease (NAFLD). It is a small molecule in Phase 3 clinical development. The drug is intended to address the metabolic condition, though it remains investigational and is not yet approved for this use.
SAMe is a small molecule that acts as a methyl donor in the body. It is involved in the synthesis of phosphatidylcholine, which is important for liver cell membrane integrity and fat metabolism. By supporting these processes, SAMe may help reduce fat accumulation in the liver, which is relevant to Non Alcoholic Fatty Liver Disease.
SAMe is being developed by Abbott Laboratories, a company traded on the stock exchange under the ticker ABT. The company is conducting clinical research on this drug for the treatment of Non Alcoholic Fatty Liver Disease, with the drug currently in Phase 3 development.
SAMe is in Phase 3 clinical development for Non Alcoholic Fatty Liver Disease. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. One Phase 3 trial has been completed, involving 108 participants, but the drug is not yet available as a treatment.
SAMe has one completed clinical trial with the identifier NCT01754714. This Phase 3 study investigated the effects of different doses of S-adenosyl-L-methionine in subjects with Non Alcoholic Fatty Liver Disease and non-treated matched healthy volunteers as a control group. The trial enrolled 108 participants across France, Germany, Poland, and Russia.
Yes, SAMe is the same as S-adenosyl-L-methionine. The drug is commonly referred to by its abbreviation SAMe, while its full chemical name is S-adenosyl-L-methionine. In clinical trials, it is studied under this name, and both names refer to the same investigational drug for Non Alcoholic Fatty Liver Disease.