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Sponsored by: |
Kythera Biopharmecuticals |
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Information provided by: | Kythera Biopharmecuticals |
ClinicalTrials.gov Identifier: | NCT00618722 |
Phase 1-2 trial to evaluate the safety and potential efficacy of three concentrations of ATX-101 compared to placebo for the reduction of submental fat.
The trial includes an initial cohort (n=3 in each arm) to evaluate safety followed by expansion to a second, larger cohort if adequate safety is determined in the initial cohort. Data from both cohorts will be pooled for analysis.
Condition | Intervention | Phase |
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Reduction of Subcutaneous Fat in the Submental Area |
Drug: ATX-101 0.5% Drug: ATX-101 1.0% concentration Drug: ATX-101 2.0% concentration Drug: Placebo vehicle |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase 1-2, Multicenter, Randomized, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of ATX-101 (Sodium Deoxycholate for Injection) for the Reduction of Subcutaneous Fat in the Submental Area |
Estimated Enrollment: | 72 |
Study Start Date: | August 2007 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Placebo: Placebo Comparator
Placebo vehicle
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Drug: Placebo vehicle
Injection into submental fat q4w
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2: ATX-101 0.5%: Active Comparator
ATX-101 0.5% concentration
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Drug: ATX-101 0.5%
Injection into submental fat q4w
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3: ATX-101 1.0%: Active Comparator
ATX-101 1.0% concentration
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Drug: ATX-101 1.0% concentration
Injection into submental fat q4w
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4: ATX-101 2.0%: Active Comparator
ATX-101 2.0% concentration
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Drug: ATX-101 2.0% concentration
Injection into submental fat q4w
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Ages Eligible for Study: | 25 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Australia | |
Toorak, Australia | |
Carina Heights, Australia | |
Canada | |
Toronto, Canada | |
United Kingdom | |
London, United Kingdom |
Study Director: | Patricia Walker, M.D., Ph.D. | Kythera Biopharmaceuticals, Inc. |
Responsible Party: | Kythera Biopharmaceuticals, Inc. ( Patricia Walker, M.D., Ph.D. ) |
Study ID Numbers: | ATX-101-06-03 |
Study First Received: | February 8, 2008 |
Last Updated: | May 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00618722 History of Changes |
Health Authority: | Australia: National Health and Medical Research Council; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Canada: Health Canada |
Submental fat |
Deoxycholic Acid |
Therapeutic Uses Cholagogues and Choleretics Gastrointestinal Agents Deoxycholic Acid Pharmacologic Actions |