EUCTR2017-002046-71-NLActive, not recruitingPhase 1
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) - Study to assess efficacy of LIK066 in obese patients with non-alcoholic steatohepatitis (NASH)
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- ovartis Pharma AG
- Enrollment
- 107
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •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.
- •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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
Exclusion Criteria
- •- 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.
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