Effect of LIK066 on Reduction of Fatty Content in Livers of Obese Patients

Completed · Phase 2 · Has a placebo group

Conditions studied: Obese Patients With Non-alcoholic Steatohepatitis (NASH)

In brief

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)

Key facts

Study ID

NCT03205150

Run by

Novartis Pharmaceuticals

People needed

107

Starts

2017-10-04

Expected to finish

2019-11-14

Last updated by the study team

2021-10-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• EITHER
• Histologic confirmed NASH based on liver biopsy obtained 2 years or less before randomization with a fibrosis level of F1, F2 or F3 in the absence of a histological diagnosis of alternative chronic liver disease AND ALT greater than or equal to 50 IU/L (males) or greater than or equal to 35 IU/L (females) at screening.
• OR
• Phenotypic diagnosis of NASH based on presence of ALL three of the following at screening:
• ALT greater than or equal to 50IU/L (males) or greater than or equal to 35 IU/L (females) AND
• BMI greater than or equal to 27 kg/m\^2 (in patients with a self-identified race other than Asian) or greater than or equal to 23 kg/m\^2 (in patients with a self identified Asian race) AND
• Diagnosis of Type 2 diabetes mellitus by HbA1c: greater than or equal to 6.5 % and less than or equal to 10%
• Patients must weigh no more than 150 kg (330 lbs) to participate in the study.
• Male and female patients 18 years or older at the time of screening visit.

You may not qualify if…

• History or presence of other concomitant liver diseases
• History or current diagnosis of ECG abnormalities
• Use of GLP-1 agonists, SGLT2 inhibitors, TZDs, FXR agonists and any pharmacologically active weight loss drugs within 6 weeks of screening and until end of study
• Patients with contraindications to MRI imaging
• Current or history of significant alcohol consumption
• Clinical evidence of hepatic decompensation or severe liver impairment
• Women of child bearing potential (unless on basic contraception methods)
• Presence of liver cirrhosis

Where it is running

• Novartis Investigative Site — Baton Rouge, Louisiana, United States
• Novartis Investigative Site — St Louis, Missouri, United States
• Novartis Investigative Site — Knoxville, Tennessee, United States
• Novartis Investigative Site — Live Oak, Texas, United States
• Novartis Investigative Site — CABA, Buenos Aires, Argentina
• Novartis Investigative Site — Buenos Aires, Argentina
• Novartis Investigative Site — Montreal, Quebec, Canada
• Novartis Investigative Site — Haifa, Israel
• Novartis Investigative Site — Ramat Gan, Israel
• Novartis Investigative Site — Tel Aviv, Israel
• Novartis Investigative Site — Leiden, Netherlands
• Novartis Investigative Site — Saint Petersburg, Russia
• Novartis Investigative Site — Chiayi City, Taiwan
• Novartis Investigative Site — Tainan, Taiwan
• Novartis Investigative Site — Bangkok, Thailand

Full record on ClinicalTrials.gov

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