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GWP42003

Phase 2

Dyslipidemias | Small molecule | Metabolic |Jazz Pharmaceuticals plc|Last Updated: Oct 18, 2022

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment62
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01217112GWMD1092 - GWP42003 : GWP42004 Together Plus Alone in Type II DiabetesPHASE2 COMPLETED 62 — — Oct 1, 2010Sep 1, 2012Oct 18, 20225 United Kingdom
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Study Endpoints
Primary Endpoints
The Change From Baseline in Mean Serum High Density Lipoprotein Cholesterol Concentration After 91 Days (13 Weeks) of Treatment
Baseline (Day 1) and End of treatment (Day 92)

At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum High Density Lipoprotein cholesterol. An increase from baseline to the end of treatment, a positive value, indicates an improvement.

Secondary Endpoints
The Change From Baseline in Mean High Density Lipoprotein Cholesterol Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment
Baseline (Day 1) and End of treatment (Day 92)
The Change From Baseline in Mean Serum Total Cholesterol Concentration After 91 Days (13 Weeks) of Treatment
Baseline (Day 1) and End of treatment (Day 92)
The Change From Baseline in Mean Total Cholesterol Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment
Baseline (Day 1) and End of treatment (Day 92)
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
GWP42004 and placeboACTIVE_COMPARATORContains GWP42004 5 mg and placebo (excipients only)
1:1 GWP42003 : GWP42004ACTIVE_COMPARATORContains 5 mg each of GWP42003 and GWP42004
20:1 GWP42003 : GWP42004ACTIVE_COMPARATORContains 100 mg GWP42003 and 5 mg GWP42004
PlaceboPLACEBO_COMPARATORContains excipients only
GWP42003 and placeboACTIVE_COMPARATORContains 100 mg GWP42003 and placebo (excipients only)
Interventions
NameTypeDescription
GWP42003DRUG100 mg capsules, PO, BD, 91 days
GWP42004DRUG5 mg capsules, PO, BD, 91 days
PlaceboDRUG0 mg capsules, QDS, PO, 91 days
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Clinically diagnosed with Type 2 diabetes, with residual islet cell function; * Diet controlled or receiving oral anti-diabetic treatment (metformin or other biguanides and/or sulphonyl ureas) who have received a stable dose for at least 3 months prior to enrollment; * High De...

Countries:United Kingdom
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