A clinical study to investigate the Effects of Different Doses of the drug product S-adenosyl-L-methionine (SAMe) in patients with Nonalcoholic Steatohepatitis (NASH) and in healthy volunteers as control group

Registry ID

EUCTR2012-000975-18

Source registry

EUCTR

Status

Completed

Phase

PHASE3

Sponsor

Abbott Laboratories GmbH

Start date

2012-09-26

Completion date

2014-09-29

Last update

2026-08-16

Conditions

• Nonalcoholic Steatohepatitis

Summary

NASH subjects The primary objective of this study is to explore the effects of different doses of SAMe on the liver using the methionine tolerance test. The primary efficacy parameter will be the methionine elimination half-life measured in blood. Healthy volunteers Primary Objective: The healthy volunteer group will serve as control group to establish the reference values for the methionine tolerance test.

Locations

• , , Germany

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