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AC2307

Phase 2

Obesity | Small molecule | Metabolic |AstraZeneca PLC|Last Updated: Jan 19, 2015

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_CONTROLLED
Total Trials1
Total Enrollment273
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00785408Study to Examine Safety, Tolerability and Effect on Body Weight of Subcutaneous AC2307 in Obese or Overweight SubjectsPHASE2 COMPLETED 273Dec 1, 2008Sep 1, 2009Jan 19, 201518 United States
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Study Endpoints
Primary Endpoints
To examine the effect on body weight of AC2307 injected subcutaneously (SC) twice daily (BID) in obese or overweight subjects
24 weeks
To assess the safety and tolerability of AC2307 injected SC BID in obese or overweight subjects
24 weeks
Secondary Endpoints
To examine the effect of AC2307 injected SC BID in obese or overweight subjects on the following parameters: waist circumference; gastric emptying rate; fasting circulating metabolic parameters; patient reported outcomes
24 weeks
To examine the pharmacokinetics of AC2307 injected SC BID in obese or overweight subjects
24 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
2EXPERIMENTAL -
3EXPERIMENTAL -
4PLACEBO_COMPARATOR -
5PLACEBO_COMPARATOR -
6PLACEBO_COMPARATOR -
Interventions
NameTypeDescription
AC2307DRUGsubcutaneous, twice daily, low dose
placeboDRUGsubcutaneous, twice daily, low dose
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites18

Inclusion Criteria: \- Is obese with a body mass index (BMI) ≥30 kg/m\^2 to ≤45 kg/m\^2, or is overweight with a BMI ≥27 kg/m\^2 to \<30 kg/m\^2 and has at least one weight-related comorbidity (dyslipidemia, impaired fasting glucose, hypertension, obstructive sleep apnea syndrome, polycystic ovary ...

Countries:United States
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