The purpose of this study is to evaluate the effect of GWP42003 on liver triglyceride (liver fat) in participants with fatty liver disease (FLD).
This study was conducted as a 10-week (eight-week treatment period and one-week safety follow-up), randomized, partially-blind study that evaluated the effect of GWP42003 in participants with raised liver triglycerides (liver fat ≥5%). Participants were clinically diagnosed with FLD and had liver fat levels ≥5% as measured by Magnetic Resonance Imaging/ Magnetic Resonance Scanning (MRI/MRS), or were willing to undergo MRI/MRS scan at the screening visit to confirm a liver fat content of ≥5%. Eligible participants entered the study at a screening visit (Day -10 to -2) and then returned for a fasted baseline visit (Day 1), a mid-treatment visit (Day 29) and an end of treatment visit (Day 57). Safety follow-up telephone calls took place throughout the treatment period up to Day 64 after completion of treatment or seven days after date of last dose/withdrawal.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
25
GWP42003 was presented as Licaps® size double zero (Size 00) hard gelatin capsules containing 100 mg of CBD dissolved in vehicle (Gelucire 44/14).
GWP42003 was presented as Licaps® Size 00 hard gelatin capsules containing 100 mg of CBD dissolved in vehicle (Gelucire 44/14).
GWP42003 was presented as Licaps® Size 00 hard gelatin capsules containing 100 mg of CBD dissolved in vehicle (Gelucire 44/14).
Unnamed facility
London, United Kingdom
Unnamed facility
Manchester, United Kingdom
Unnamed facility
Manchester, United Kingdom
Percent Change From Baseline To The End Of Treatment (EOT) In Mean Liver Triglyceride Levels
Liver triglyceride levels were measured by Magnetic Resonance Imaging/Magnetic Resonance Scanning and the percent change from baseline to EOT in group mean levels was investigated. A reduction from baseline, that is, a negative value, indicates an improvement in condition.
Time frame: Baseline to EOT (Day 57) or Early Termination (ET)
Change From Baseline To The EOT In Mean Serum Total Cholesterol Levels
A fasting blood sample was taken for the measurement of serum total cholesterol. A reduction from baseline, that is, a negative value, indicates an improvement in condition.
Time frame: Baseline to EOT (Day 57) or ET
Change From Baseline To The EOT In Mean Serum High Density Lipoprotein (HDL)-Cholesterol(C) Levels
A fasting blood sample was obtained for the measurement of HDL-C. An increase from baseline, that is, a positive value, indicates an improvement in condition.
Time frame: Baseline to EOT (Day 57) or ET
Change From Baseline To The EOT In Mean Serum Low-Density Lipoprotein (LDL)-C Levels
A fasting blood sample was obtained for the measurement of LDL-C. An increase from baseline, that is, a positive value, indicates an improvement in condition.
Time frame: Baseline to EOT (Day 57) or ET
Change From Baseline To The EOT In Mean Serum HDL: Low Density Lipoprotein (LDL)-Cholesterol (C) Ratio
A fasting blood sample was obtained for the measurement of HDL-C and LDL-C, allowing the HDL:LDL cholesterol ratio to be calculated. An increase from baseline, that is, a positive value, indicates an improvement in condition.
Time frame: Baseline to EOT (Day 57) or ET
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Placebo was presented as Licaps® Size 00 hard gelatin capsules containing excipients (Gelucire 44/14).
Change From Baseline To The EOT In Mean Serum Triglyceride Levels
A fasting blood sample was obtained for the measurement of serum triglycerides. A reduction from baseline, that is, a negative value, indicates an improvement in condition.
Time frame: Baseline to EOT (Day 57) or ET