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AC2307

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment273

FDA Designations

No designations recorded

Clinical trial landscape

AC2307 · 1 trial · 2 indications

Phase 2 1
NCT00785408Study to Examine Safety, Tolerability and Effect on Body Weight of Subcutaneous AC2307 in Obese or Overweight SubjectsObesity
COMPLETED273 Analytics
PHASE2COMPLETED
Study to Examine Safety, Tolerability and Effect on Body Weight of Subcutaneous AC2307 in Obese or Overweight Subjects
ObesityUnlock trial analytics

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 to 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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Frequently asked questions about AC2307

What is AC2307 used for?

AC2307 is an investigational small molecule being developed for the treatment of obesity and overweight. It is administered subcutaneously and is currently in Phase 2 clinical development. The drug is being studied for its effect on body weight in obese or overweight subjects.

Who is developing AC2307?

AC2307 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. The company is conducting clinical trials to evaluate the safety, tolerability, and efficacy of AC2307 in patients with obesity or overweight.

What phase is AC2307 in?

AC2307 is in Phase 2 clinical development. A Phase 2 trial has been completed, which was a randomized, double-blind, placebo-controlled study. The drug is investigational and has not yet been approved by regulatory authorities.

What clinical trials has AC2307 been in?

AC2307 has been studied in one clinical trial with the identifier NCT00785408. This Phase 2 study examined the safety, tolerability, and effect on body weight of subcutaneous AC2307 in obese or overweight subjects. The trial enrolled 273 participants in the United States and has been completed.

How was the AC2307 clinical trial designed?

The AC2307 clinical trial, NCT00785408, was a randomized, double-blind, placebo-controlled study. It enrolled 273 participants aged 18 years and older, including both males and females, with obesity or overweight. The trial was conducted in the United States and has been completed.