CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 107 enrolled
Drug / intervention
LIK066 +1 moredrug
Likely dose
LIK066 30mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03205150
NCT03205150Phase 2Completed
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A 12-week Randomized, Patient and Investigator Blinded, Placebo-controlled, Parallel Group Study to Investigate the Efficacy of LIK066 in Obese Patients With Non-alcoholic Steatohepatitis (NASH)

Novartis Pharmaceuticals·interventional·Posted Jul 2, 2017·Updated Oct 8, 2021

In Brief

A Phase 2 clinical trial evaluating LIK066 and Placebo for Obese Patients With Non-alcoholic Steatohepatitis (NASH). Completed, enrolled 107 participants across 15 sites in 8 countries.

Detailed Summary

The purpose of this study was to assess the effects of LIK066 on a variety of metabolic and inflammation biomarkers in patients with non-alcoholic steatohepatitis (NASH)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObese Patients With Non-alcoholic Steatohepatitis (NASH)
CountriesArgentina, Canada, Israel, Netherlands, Russia, Taiwan, Thailand, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedJul 2, 2017
Enrollment StartOct 4, 2017
Primary CompletionNov 11, 2019
Study CompletionNov 14, 2019
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 9 years ago

Interventions

LIK066drug

Film coated tablet of LIK066 either 30mg or 150 mg was mostly administered once daily before lunch, except on Day 56 when it was administered before breakfast and in fasted state on Day 84

Placebodrug

LIK066 0 mg film-coated tablet(Placebo matching tablets) was mostly administered once daily before lunch, except on Day 56 when it was administered before breakfast and in fasted state on Day 84.