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Study to Examine Safety, Tolerability and Effect on Body Weight of Subcutaneous AC2307 in Obese or Overweight Subjects

NCT ID: NCT00785408

Last Updated: 2015-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

273 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2009-09-30

Brief Summary

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A randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study to examine the safety, tolerability, and effect on body weight of subcutaneous AC2307 in obese or overweight subjects.

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Detailed Description

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Conditions

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Obesity Overweight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type EXPERIMENTAL

AC2307

Intervention Type DRUG

subcutaneous, twice daily, low dose

2

Group Type EXPERIMENTAL

AC2307

Intervention Type DRUG

subcutaneous, twice daily, middle dose

3

Group Type EXPERIMENTAL

AC2307

Intervention Type DRUG

subcutaneous, twice daily, high dose

4

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

subcutaneous, twice daily, low dose

5

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

subcutaneous, twice daily, middle dose

6

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

subcutaneous, twice daily, high dose

Interventions

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AC2307

subcutaneous, twice daily, low dose

Intervention Type DRUG

placebo

subcutaneous, twice daily, low dose

Intervention Type DRUG

AC2307

subcutaneous, twice daily, middle dose

Intervention Type DRUG

placebo

subcutaneous, twice daily, middle dose

Intervention Type DRUG

AC2307

subcutaneous, twice daily, high dose

Intervention Type DRUG

placebo

subcutaneous, twice daily, high dose

Intervention Type DRUG

Eligibility Criteria

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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 syndrome, and/or osteoarthritis)

Exclusion Criteria

* Has had a major change in daily physical activity (e.g., initiation of an exercise program) or has been enrolled in a weight loss program within 2 months prior to study start
* Has received AC2307 or pramlintide in a clinical study or has received prior treatment with pramlintide (SYMLIN®) or calcitonin
* Has received any investigational drug within 1 month or within a period corresponding to five times the half-life of the investigational drug, whichever is greater, before study start
* Has donated blood within 2 months before study start or is planning to donate blood during the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hubert Chen, MD

Role: STUDY_DIRECTOR

Amylin Pharmaceuticals, LLC.

Locations

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Research Site

Birmingham, Alabama, United States

Site Status

Research Site

Chandler, Arizona, United States

Site Status

Research Site

Santa Rosa, California, United States

Site Status

Research Site

Walnut Creek, California, United States

Site Status

Research Site

Denver, Colorado, United States

Site Status

Research Site

Jacksonville, Florida, United States

Site Status

Research Site

Miami, Florida, United States

Site Status

Research Site

Chicago, Illinois, United States

Site Status

Research Site

Overland Park, Kansas, United States

Site Status

Research Site

Baton Rouge, Louisiana, United States

Site Status

Research Site

Butte, Montana, United States

Site Status

Research Site

Cincinnati, Ohio, United States

Site Status

Research Site

Eugene, Oregon, United States

Site Status

Research Site

Medford, Oregon, United States

Site Status

Research Site

Greer, South Carolina, United States

Site Status

Research Site

Mt. Pleasant, South Carolina, United States

Site Status

Research Site

Austin, Texas, United States

Site Status

Research Site

Olympia, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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CFA104

Identifier Type: -

Identifier Source: org_study_id

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