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AZD4017

Phase 1

Obesity | Small molecule | Metabolic |AstraZeneca PLC|Last Updated: Dec 10, 2010

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
RandomizedPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment15
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01096004Study to Evaluate Methods That Assess the Effect of AZD4017 in Adipose TissuePHASE1 COMPLETED 15 — — Mar 1, 2010May 1, 2010Dec 10, 20101 Sweden
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Study Endpoints
Primary Endpoints
To investigate the effect of single and repeated doses of AZD4017 and placebo on mechanisms in adipose tissue involved in metabolic regulation
A adipose tissue biospy is taken at baseline, on first day of dosing day, on 4th dosing day and on 9th dosing day.
Secondary Endpoints
Safety and Tolerability (Adverse events, vital signs, ECGs, physical examination, laboratory variables
The variables will be measure predose and the repeatedly during the following 10 days after dosing
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
2PLACEBO_COMPARATOR -
Interventions
NameTypeDescription
AZD4017DRUGoral suspension, 1200mg, once daily, for 10 days
PlaceboDRUG -
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Eligibility Criteria
Age Range18 Years — 65 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Provision of signed written and dated informed consent * Have a body mass index (BMI) between 27 and 35 kg/m2 * Waist circumference of \>102 cm Exclusion Criteria: * History of any clinical significant disease * Any clinically significant illness, medical/surgical procedure ...

Countries:Sweden
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Competitive Landscape -Obesity 202 trials
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