Fatty LiverPhase 2NCT01284634
Study to Evaluate the Effect of GWP42003 on Liver Fat Levels in Participants With Fatty Liver Disease
A Phase 2 study testing GWP42003 200 mg/day Dose, GWP42003 400 mg/day Dose and GWP42003 800 mg/day Dose in people with Fatty Liver, run by GW Research Ltd at 3 sites in United Kingdom.
Trial summary
The purpose of this study is to evaluate the effect of GWP42003 on liver triglyceride (liver fat) in participants with fatty liver disease (FLD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fatty Liver
- What is being tested?
- GWP42003 200 mg/day Dose, GWP42003 400 mg/day Dose and GWP42003 800 mg/day Dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 3 May 2011to 13 Jul 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant gave informed consent for participation in the study.
- Participant was aged 18 years or above.
- Participant had documented evidence of liver fat content ≥5% as measured by MRI/MRS scanning or a biopsy within two months prior to screening, or willing to undergo an MRI/MRS scan at Visit 1 (Day -10 to -2) to confirm a liver fat content of ≥5%.
- Participant had, in the opinion of the investigator, no changes in levels of exercise or diet for four weeks (as assessed by the physical activity questionnaire and food frequency questionnaire) prior to the start of treatment, and participant agreed to keep stable for the duration of the study.
- Participant was able (in the investigator's opinion) and willing to comply with all study requirements.
- Participant was willing for his or her name to be notified to the responsible authorities for participation in this study, as applicable.
- Participant was willing to allow his or her primary care practitioner and consultant, if appropriate, to be notified of participation in the study.
Who cannot join
- Participant had clinical diagnosis or treatment for Type I/II diabetes.
- Participant had received an unapproved investigational medicinal product (IMP) within the 30 days prior to the screening visit.
- Participant was receiving a prohibited medication and unwilling to stop for 14 days prior to the screening visit and for the duration of the study.
- Participant was using or had used recreational cannabis, medicinal cannabis, or cannabinoid medications (including Sativex) within one month prior to study entry and unwilling to abstain for the duration of the study.
- Participant had any known or suspected history of alcohol or substance abuse, or epilepsy or recurrent seizures.
- Participant had any known or suspected history of major depression sufficient to require treatment or disrupt ordinary life (excluding episodes of reactive depression, in the opinion of the investigator).
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- Participant had clinically significant cardiac, renal, or hepatic impairment, in the opinion of the investigator.
- Participant had known history of Hepatitis B or C.
- Participant had genetic dyslipidaemia, in the opinion of the Investigator.
- Participant had any other significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, influence the result of the study, or affect the participant's ability to participate in the study.
- Participant had any known or suspected hypersensitivity to cannabinoids or any of the excipients of the IMP(s).
- Participant had presence of any metal implants.
- Participant had any known or suspected history of claustrophobia.
- Female participants of child bearing potential not able or willing to use effective contraception for the duration of the study and for three months thereafter, or male participants whose partner was of child bearing potential, who was not willing to ensure that they or their partner would use effective contraception during the study and for three months thereafter.
- Female participant who was pregnant, lactating or planning pregnancy during the course of the study and for three months thereafter.
- Participants who weighed >150 kilograms (kg).
- Participant had any abnormalities following a physical examination that, in the opinion of the investigator, prevented the participant from safe participation in the study.
- Participant was unwilling to abstain from donation of blood during the study.
- Participant had planned travel outside the country of residence during the study.
- Participant had previously enrolled into this study.
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Study site
London, W120NN
Study site
Manchester, M13 9WL
Study site
Manchester, M32 0UT
About this study
Official title: A Randomised, Partially-blind, Placebo-controlled, Pilot, Dose-ranging Study To Assess The Effect Of Cannabidiol (CBD) On Liver Fat Levels In Subjects With Fatty Liver Disease.
The purpose of this study is to evaluate the effect of GWP42003 on liver triglyceride (liver fat) in participants with fatty liver disease (FLD).
Read the detailed description
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.
- Conditions
- Fatty Liver
- Being tested
- GWP42003 200 mg/day Dose, GWP42003 400 mg/day Dose, GWP42003 800 mg/day Dose, Placebo
- Keywords
- Cannabidiol, Fatty liver, Diabetes, Body fat
- Medical subject headings
- Fatty Liver, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GWP42003 200 mg/day DoseDrug
Also called Cannabidiol, CBD
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 400 mg/day DoseDrug
Also called Cannabidiol, CBD
GWP42003 was presented as Licaps® Size 00 hard gelatin capsules containing 100 mg of CBD dissolved in vehicle (Gelucire 44/14).
GWP42003 800 mg/day DoseDrug
Also called Cannabidiol, CBD
GWP42003 was presented as Licaps® Size 00 hard gelatin capsules containing 100 mg of CBD dissolved in vehicle (Gelucire 44/14).
PlaceboDrug
Also called Placebo control
Placebo was presented as Licaps® Size 00 hard gelatin capsules containing excipients (Gelucire 44/14).
| Study group | Role | What they receive |
|---|---|---|
| GWP42003 200 milligrams (mg)/day Dose | Experimental | Participants self-administered one x 100 mg GWP42003 capsule twice daily for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). Receives: Drug: GWP42003 200 mg/day Dose |
| GWP42003 400 mg/day Dose | Experimental | Participants self-administered two x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). Receives: Drug: GWP42003 400 mg/day Dose |
| GWP42003 800 mg/day Dose | Experimental | Participants self-administered four x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). Receives: Drug: GWP42003 800 mg/day Dose |
| Placebo | Experimental | Participants self-administered one, two or four placebo capsules twice daily, for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to EOT (Day 57) or Early Termination (ET)
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to EOT (Day 57) or ET
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.
Measured: Baseline to EOT (Day 57) or ET
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2011 (estimated)
- Study start3 May 2011
- Primary completion13 Jul 2012
- Study completion13 Jul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Fatty LiverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- GW Research Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01284634
- Sponsor's protocol ID
- GWMD09112
- Other IDs
- 2009-017080-41, 2009
- Status last verified
- Jul 2018
- First submitted
- 26 Jan 2011
- Last updated
- 8 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Partially-blind, Placebo-controlled, Pilot, Dose-ranging Study To Assess The Effect Of Cannabidiol (CBD) On Liver Fat Levels In Subjects With Fatty Liver Disease.
- ClinicalTrials.gov ID
- NCT01284634
- Acronym / sponsor ID
- GWMD09112
- Conditions
- Fatty Liver
- Keywords
- Cannabidiol, Fatty liver, Diabetes, Body fat
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- GW Research LtdIndustry (pharma, biotech, devices)
- Study start
- 3 May 2011 (actual)
- Primary completion
- 13 Jul 2012 (actual)
- Study completion
- 13 Jul 2012 (actual)
- First posted
- 27 Jan 2011 (estimated)
- Results
- Posted 20 Jan 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effect of GWP42003 on liver triglyceride (liver fat) in participants with fatty liver disease (FLD).
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| GWP42003 200 milligrams (mg)/day Dose | Experimental | Drug: GWP42003 200 mg/day DoseParticipants self-administered one x 100 mg GWP42003 capsule twice daily for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). |
| GWP42003 400 mg/day Dose | Experimental | Drug: GWP42003 400 mg/day DoseParticipants self-administered two x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). |
| GWP42003 800 mg/day Dose | Experimental | Drug: GWP42003 800 mg/day DoseParticipants self-administered four x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). |
| Placebo | Experimental | Drug: PlaceboParticipants self-administered one, two or four placebo capsules twice daily, for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participant gave informed consent for participation in the study.
- Participant was aged 18 years or above.
- Participant had documented evidence of liver fat content ≥5% as measured by MRI/MRS scanning or a biopsy within two months prior to screening, or willing to undergo an MRI/MRS scan at Visit 1 (Day -10 to -2) to confirm a liver fat content of ≥5%.
- Participant had, in the opinion of the investigator, no changes in levels of exercise or diet for four weeks (as assessed by the physical activity questionnaire and food frequency questionnaire) prior to the start of treatment, and participant agreed to keep stable for the duration of the study.
- Participant was able (in the investigator's opinion) and willing to comply with all study requirements.
Key exclusion criteria (20 listed)
- Participant had clinical diagnosis or treatment for Type I/II diabetes.
- Participant had received an unapproved investigational medicinal product (IMP) within the 30 days prior to the screening visit.
- Participant was receiving a prohibited medication and unwilling to stop for 14 days prior to the screening visit and for the duration of the study.
- Participant was using or had used recreational cannabis, medicinal cannabis, or cannabinoid medications (including Sativex) within one month prior to study entry and unwilling to abstain for the duration of the study.
- Participant had any known or suspected history of alcohol or substance abuse, or epilepsy or recurrent seizures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GWP42003 200 mg/day DoseAlso: Cannabidiol, CBDGWP42003 was presented as Licaps® size double zero (Size 00) hard gelatin capsules containing 100 mg of CBD dissolved in vehicle (Gelucire 44/14). | Drug | GWP42003 200 milligrams (mg)/day Dose |
| GWP42003 400 mg/day DoseAlso: Cannabidiol, CBDGWP42003 was presented as Licaps® Size 00 hard gelatin capsules containing 100 mg of CBD dissolved in vehicle (Gelucire 44/14). | Drug | GWP42003 400 mg/day Dose |
| GWP42003 800 mg/day DoseAlso: Cannabidiol, CBDGWP42003 was presented as Licaps® Size 00 hard gelatin capsules containing 100 mg of CBD dissolved in vehicle (Gelucire 44/14). | Drug | GWP42003 800 mg/day Dose |
| PlaceboAlso: Placebo controlPlacebo was presented as Licaps® Size 00 hard gelatin capsules containing excipients (Gelucire 44/14). | Drug | Placebo |
Primary outcome
Percent Change From Baseline To The End Of Treatment (EOT) In Mean Liver Triglyceride Levels
Time frame: Baseline to EOT (Day 57) or Early Termination (ET)
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.
5 secondary outcomes
Change From Baseline To The EOT In Mean Serum Total Cholesterol Levels
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
Time frame: Baseline to EOT (Day 57) or ET
Change From Baseline To The EOT In Mean Serum Low-Density Lipoprotein (LDL)-C Levels
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
Time frame: Baseline to EOT (Day 57) or ET
Change From Baseline To The EOT In Mean Serum Triglyceride Levels
Time frame: Baseline to EOT (Day 57) or ET
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GWP42003 200 mg/day Dose, GWP42003 400 mg/day Dose and GWP42003 800 mg/day Dose in people with Fatty Liver, run by GW Research Ltd at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change From Baseline To The End Of Treatment (EOT) In Mean Liver Triglyceride Levels (time frame: Baseline to EOT (Day 57) or Early Termination (ET)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2018.