Phase 2
N=107
Effect of LIK066 on Reduction of Fatty Content in Livers of Obese Patients
Obese Patients With Non-alcoholic Steatohepatitis (NASH)
Bottom Line
View on ClinicalTrials.gov: NCT03205150 ↗Enrolled (actual)
107
Serious AEs
0.9%
Results posted
Jan 2021
Primary outcome: Primary: Change From Baseline in Alanine Aminotransferase (ALT) at Week 12 — -22.06; -30.41; -8.77 Units per Liter (U/L) — p=0.075
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- LIK066 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Alanine Aminotransferase (ALT) at Week 12 |
-22.06; -30.41; -8.77 | 0.075 |
| SECONDARY Change From Baseline in Percent Liver Fat at Week 12 |
-4.40; -6.92; -2.67 | 0.235 |
| SECONDARY Percent Change From Baseline in Total Body Weight at Week 12 |
-3.48; -4.51; -0.33 | <.001 sig |
| SECONDARY Change From Baseline in Non-invasive Markers of Hepatic Fibrosis: Enhanced Liver Fibrosis Test (ELF) Score at Week 12 |
-0.2; -0.1; 0.1 | — |
| SECONDARY Change From Baseline in the Concentration of Hyaluronic Acid at Week 12. |
-3.4; 0.4; 4.7 | — |
| SECONDARY Change From Baseline in the Concentration of Procollagen Type Iii N-Terminal Peptide (PIIINP) at Week 12. |
-1.7; -1.2; 0.3 | — |
| SECONDARY Change From Baseline in the Concentration of Tissue Inhibitor Of Metalloproteinase 1 (TIMP-1) at Week 12. |
-3.0; -10.9; 10.3 | — |
| SECONDARY Pharmacokinetics of LIK066: Observed Maximum Plasma Concentration (Cmax) Following Drug Administration |
405; 1810 | — |
| SECONDARY Pharmacokinetics of LIK066: Observed Maximum Time Duration of Maximum Concentration (Tmax) Following Drug Administration |
1.00; 1.51 | — |
| SECONDARY Pharmacokinetics of LIK066: Observed Area Under the Curve up to the Last Measurable Concentration (AUClast) Following Drug Administration |
1280; 5770 | — |
| SECONDARY Change From Baseline in Aspartate Aminotransferase (AST) at Week 12 |
-13.45; -17.01; -2.30 | 0.013 sig |
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)
Eligibility Criteria
Inclusion Criteria
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.
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
Data sourced from ClinicalTrials.gov (NCT03205150). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.