Trial · NCT01284634
Study to Evaluate the Effect of GWP42003 on Liver Fat Levels in Participants With Fatty Liver Disease
NCT01284634, Phase 2, Completed, GW Research Ltd; results first posted 2014-01-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Evaluate the Effect of GWP42003 on Liver Fat Levels in Participants With Fatty Liver Disease. Trials, record NCT01284634. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01284634
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate the Effect of GWP42003 on Liver Fat Levels in Participants With Fatty Liver Disease
- NCT number
- NCT01284634
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 25 participants, actual
- Lead sponsor
- GW Research Ltd
- Conditions
- Fatty Liver
- Interventions
- GWP42003 200 mg/day Dose, GWP42003 400 mg/day Dose, GWP42003 800 mg/day Dose, Placebo
- First posted
- 2011-01-27
- Last updated
- 2018-08-08
- Other registries' IDs
- eudract:2009-017080-41
- Results first posted
- 2014-01-20
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline To The End Of Treatment (EOT) In Mean Liver Triglyceride Levels | 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. |
| Secondary | Change From Baseline To The EOT In Mean Serum Total Cholesterol Levels | Baseline to EOT (Day 57) or ET | 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. |
| Secondary | Change From Baseline To The EOT In Mean Serum High Density Lipoprotein (HDL)-Cholesterol(C) Levels | Baseline to EOT (Day 57) or ET | 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. |
| Secondary | Change From Baseline To The EOT In Mean Serum Low-Density Lipoprotein (LDL)-C Levels | Baseline to EOT (Day 57) or ET | 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. |
| Secondary | Change From Baseline To The EOT In Mean Serum HDL: Low Density Lipoprotein (LDL)-Cholesterol (C) Ratio | Baseline to EOT (Day 57) or ET | 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. |
| Secondary | Change From Baseline To The EOT In Mean Serum Triglyceride Levels | Baseline to EOT (Day 57) or ET | 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. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change From Baseline To The End Of Treatment (EOT) In Mean Liver Triglyceride Levels | Baseline to EOT (Day 57) or Early Termination (ET) | ITT analysis set: All participants who were randomized, received at least one dose of study medication, and had on-treatment efficacy data. Participants who did not have any relevant post-randomization efficacy data were excluded from the analysis. | percentage change | MEAN |
| SECONDARY | Change From Baseline To The EOT In Mean Serum Total Cholesterol Levels | Baseline to EOT (Day 57) or ET | ITT analysis set: All participants who were randomized, received at least one dose of study medication, and had on-treatment efficacy data. Participants who did not have any relevant post-randomization efficacy data were excluded from the analysis. | millimole (mmol)/l | MEAN |
| SECONDARY | Change From Baseline To The EOT In Mean Serum High Density Lipoprotein (HDL)-Cholesterol(C) Levels | Baseline to EOT (Day 57) or ET | ITT analysis set: All participants who were randomized, received at least one dose of study medication, and had on-treatment efficacy data. Participants who did not have any relevant post-randomization efficacy data were excluded from the analysis. | mmol/l | MEAN |
| SECONDARY | Change From Baseline To The EOT In Mean Serum Low-Density Lipoprotein (LDL)-C Levels | Baseline to EOT (Day 57) or ET | ITT analysis set: All participants who were randomized, received at least one dose of study medication, and had on-treatment efficacy data. Participants who did not have any relevant post-randomization efficacy data were excluded from the analysis. | mmol/l | MEAN |
| SECONDARY | Change From Baseline To The EOT In Mean Serum HDL: Low Density Lipoprotein (LDL)-Cholesterol (C) Ratio | Baseline to EOT (Day 57) or ET | ITT analysis set: All participants who were randomized, received at least one dose of study medication, and had on-treatment efficacy data. Participants who did not have any relevant post-randomization efficacy data were excluded from the analysis. | change in ratio | MEAN |
| SECONDARY | Change From Baseline To The EOT In Mean Serum Triglyceride Levels | Baseline to EOT (Day 57) or ET | ITT analysis set: All participants who were randomized, received at least one dose of study medication, and had on-treatment efficacy data. Participants who did not have any relevant post-randomization efficacy data were excluded from the analysis. | mmol/l | MEAN |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change From Baseline To The End Of Treatment (EOT) In Mean Liver Triglyceride Levels | GWP42003 200 mg/Day Dose | -0.68 | Standard Deviation 4.97 | percentage change | |
| Percent Change From Baseline To The End Of Treatment (EOT) In Mean Liver Triglyceride Levels | GWP42003 400 mg/Day Dose | -0.28 | Standard Deviation 8.60 | percentage change | |
| Percent Change From Baseline To The End Of Treatment (EOT) In Mean Liver Triglyceride Levels | GWP42003 800 mg/Day Dose | 0.65 | Standard Deviation 5.28 | percentage change | |
| Percent Change From Baseline To The End Of Treatment (EOT) In Mean Liver Triglyceride Levels | Placebo | 6.36 | Standard Deviation 17.97 | percentage change | |
| Change From Baseline To The EOT In Mean Serum Total Cholesterol Levels | GWP42003 200 mg/Day Dose | 0.07 | Standard Deviation 0.76 | millimole (mmol)/l | |
| Change From Baseline To The EOT In Mean Serum Total Cholesterol Levels | GWP42003 400 mg/Day Dose | 0.03 | Standard Deviation 0.51 | millimole (mmol)/l | |
| Change From Baseline To The EOT In Mean Serum Total Cholesterol Levels | GWP42003 800 mg/Day Dose | -0.14 | Standard Deviation 0.31 | millimole (mmol)/l | |
| Change From Baseline To The EOT In Mean Serum Total Cholesterol Levels | Placebo | -0.62 | Standard Deviation 1.00 | millimole (mmol)/l | |
| Change From Baseline To The EOT In Mean Serum High Density Lipoprotein (HDL)-Cholesterol(C) Levels | GWP42003 200 mg/Day Dose | 0.07 | Standard Deviation 0.15 | mmol/l | |
| Change From Baseline To The EOT In Mean Serum High Density Lipoprotein (HDL)-Cholesterol(C) Levels | GWP42003 400 mg/Day Dose | 0.08 | Standard Deviation 0.15 | mmol/l |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | GWP42003 200 Milligram (mg)/Day Dose | 7 | |
| Overall Study | STARTED | GWP42003 400 mg/Day Dose | 6 | |
| Overall Study | STARTED | GWP42003 800 mg/Day Dose | 7 | |
| Overall Study | STARTED | Placebo | 5 | |
| Overall Study | Received at Least 1 Dose of Study Drug | GWP42003 200 Milligram (mg)/Day Dose | 7 | |
| Overall Study | Received at Least 1 Dose of Study Drug | GWP42003 400 mg/Day Dose | 6 | |
| Overall Study | Received at Least 1 Dose of Study Drug | GWP42003 800 mg/Day Dose | 7 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Placebo | 5 | |
| Overall Study | Intent to Treat (ITT) Analysis Set | GWP42003 200 Milligram (mg)/Day Dose | 7 | |
| Overall Study | Intent to Treat (ITT) Analysis Set | GWP42003 400 mg/Day Dose | 6 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events200
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Ear pain | Ear and labyrinth disorders | GWP42003 200 mg/Day Dose | 0 | 7 | |
| other | Ear pain | Ear and labyrinth disorders | GWP42003 400 mg/Day Dose | 0 | 6 | |
| other | Ear pain | Ear and labyrinth disorders | 800 mg GWP42003 | 1 | 7 | |
| other | Ear pain | Ear and labyrinth disorders | Placebo | 0 | 5 | |
| other | Meniere's disease | Ear and labyrinth disorders | GWP42003 200 mg/Day Dose | 1 | 7 | |
| other | Meniere's disease | Ear and labyrinth disorders | GWP42003 400 mg/Day Dose | 0 | 6 | |
| other | Meniere's disease | Ear and labyrinth disorders | 800 mg GWP42003 | 0 | 7 | |
| other | Meniere's disease | Ear and labyrinth disorders | Placebo | 0 | 5 | |
| other | Abdominal distension | Gastrointestinal disorders | GWP42003 200 mg/Day Dose | 0 | 7 | |
| other | Abdominal distension | Gastrointestinal disorders | GWP42003 400 mg/Day Dose | 1 | 6 |
1 to 10 of 200Source ClinicalTrials.gov
See all 200 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | GWP42003 200 mg/Day Dose | ||
| Total, all-cause mortality | GWP42003 400 mg/Day Dose | ||
| Total, all-cause mortality | 800 mg GWP42003 | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | GWP42003 200 mg/Day Dose | 6 | 7 |
| Total, other adverse events | GWP42003 400 mg/Day Dose | 5 | 6 |
| Total, other adverse events | 800 mg GWP42003 | 7 | 7 |
| Total, other adverse events | Placebo | 5 | 5 |
| Total, serious adverse events | GWP42003 200 mg/Day Dose | 0 | 7 |
| Total, serious adverse events | GWP42003 400 mg/Day Dose | 0 | 6 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01284634
GET https://conductscience.org/api/trials/v1/NCT01284634/results?page=2