Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GWP42004 · 1 trial · 1 indication
At baseline and at the end of treatment, a fasting blood sample is taken for measurement of HbA1c levels. Values are calculated as a percentage of total haemoglobin. A decrease from baseline to the end of treatment in base per cent values, a negative value, indicates an improvement.
| Arm | Type | Description |
|---|---|---|
| 2 mg GWP42004 bid | ACTIVE_COMPARATOR | Licaps® size double zero (Size 00) hard gelatin capsules containing 2 mg GWP42004 dissolved in excipients Macrogolglycerol Ricinoleate and Oleoyl macrogol-6-glycerides. One capsule taken twice daily for 12 weeks. |
| 5 mg GWP42004 bid | ACTIVE_COMPARATOR | Licaps® size double zero (Size 00) hard gelatin capsules containing 5 mg GWP42004 dissolved in excipients Macrogolglycerol Ricinoleate and Oleoyl macrogol-6-glycerides. One capsule taken twice daily for 12 weeks. |
| 15 mg GWP42004 bid | ACTIVE_COMPARATOR | Licaps® size double zero (Size 00) hard gelatin capsules containing 15 mg GWP42004 dissolved in excipients Macrogolglycerol Ricinoleate and Oleoyl macrogol-6-glycerides. One capsule taken twice daily for 12 weeks. |
| Placebo | PLACEBO_COMPARATOR | Licaps® size double zero (Size 00) hard gelatin capsules containing excipients Macrogolglycerol Ricinoleate and Oleoyl macrogol-6-glycerides. One capsule taken twice daily for 12 weeks. |
| Name | Type | Description |
|---|---|---|
| GWP42004 | DRUG | The total dose administered within any 24-hour interval will be two capsules (typically 12 hours apart). |
| Placebo | DRUG | The total dose administered within any 24-hour interval will be two capsules (typically 12 hours apart). |
Inclusion Criteria: * Participant is willing and able to give informed consent for participation in the study (see Section 15.2). * Male or female participants aged 18 years or above. * Clinically diagnosed with Type 2 diabetes. * Participants receiving oral metformin (≥1000 mg per day) as anti-dia...
GWP42004 is an investigational small molecule being studied for the treatment of Type 2 Diabetes Mellitus. It was evaluated in a Phase 2 clinical trial as an add-on therapy to metformin in participants with Type 2 diabetes. The drug is still in clinical development and has not been approved by regulatory authorities.
GWP42004 is being developed by Jazz Pharmaceuticals plc, a biopharmaceutical company listed on the NASDAQ under the ticker JAZZ. The company is conducting clinical research on this investigational drug for the treatment of Type 2 Diabetes Mellitus.
GWP42004 is in Phase 2 clinical development. A Phase 2 trial of the drug has been completed, with a total enrollment of 207 participants. The drug remains investigational and has not received regulatory approval for any indication.
GWP42004 was studied in a completed Phase 2 clinical trial with the identifier NCT02053272. The trial was titled 'A Study of GWP42004 as Add on to Metformin in the Treatment of Participants With Type 2 Diabetes' and enrolled 207 participants in Romania and the United Kingdom.
The specific molecular target of GWP42004 has not been disclosed in available clinical trial information. The drug is being investigated as an add-on therapy to metformin for the treatment of Type 2 Diabetes Mellitus, but its mechanism of action has not been publicly detailed.