Open-label, Randomized, Parallel-Group, Exploratory Study to Investigate the Effects of Different Doses of S-adenosyl-L-methionine (SAMe) in Subjects With Nonalcoholic Steatohepatitis (NASH) and Non-treated Matched Healthy Volunteers as Control Group (EXPO)

NCT01754714 Phase 3 COMPLETED Results posted

Investigation the Effects of Different Doses of SAMe in Subjects with Nonalcoholic Fatty Liver Disease and non-treated matched healthy volunteers as control group

Details

Lead sponsor	Abbott
Phase	Phase 3
Status	COMPLETED
Enrolment	108
Start date	2012-12
Completion	2014-09

Conditions

• Non Alcoholic Fatty Liver Disease

Interventions

• SAMe 1000 mg
• SAMe 1500 mg
• SAMe 2000 mg

Primary outcomes

• Methionine Elimination Half-life Measured in Blood. — 0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours*at Week 7*
  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.

Countries

France, Germany, Poland, Russia