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 is S-adenosyl-L-methionine, a small molecule therapeutic being studied for the treatment of non alcoholic fatty liver disease, a metabolic condition. It is also known as SAMe 1000 mg. Abbott Laboratories, ticker ABT, is developing it, and it has reached Phase 3 clinical development.
SAMe is being developed as a treatment for non alcoholic fatty liver disease, a metabolic liver condition. Its clinical program has evaluated it in adults with this disease. It is investigational and has not been established as an approved therapy for this indication.
Abbott Laboratories, which trades under the ticker ABT, is the developer of SAMe. The company sponsored the Phase 3 clinical study of SAMe in non alcoholic fatty liver disease, which enrolled 108 participants across France, Germany, Poland, and Russia.
SAMe is in Phase 3 clinical development for non alcoholic fatty liver disease. One Phase 3 trial has been completed, and no trials are currently active. SAMe is an investigational small molecule and is not an approved treatment for this indication.
SAMe has been studied in one completed Phase 3 trial, NCT01754714, titled a study of different doses of S-adenosyl-L-methionine in subjects with nonalcoholic fatty liver disease, with non-treated matched healthy volunteers as a control group. It enrolled 108 participants, was randomized, and was not double blind.