Phase 1-2 Study of ATX-101 for the Reduction of Submental Fat - Full Text View

Sponsored by:	Kythera Biopharmecuticals
Information provided by:	Kythera Biopharmecuticals
ClinicalTrials.gov Identifier:	NCT00618722

Purpose

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
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

U.S. FDA Resources

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

Further study details as provided by Kythera Biopharmecuticals:

Primary Outcome Measures:

Safety (physical examinations, clinical laboratory tests, adverse event assessments) [ Time Frame: Six Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Efficacy (submental fat rating scale, subject satisfaction, global improvement) [ Time Frame: Six Months ] [ Designated as safety issue: No ]

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
1: Placebo: Placebo Comparator Placebo vehicle	Drug: Placebo vehicle Injection into submental fat q4w
2: ATX-101 0.5%: Active Comparator ATX-101 0.5% concentration	Drug: ATX-101 0.5% Injection into submental fat q4w
3: ATX-101 1.0%: Active Comparator ATX-101 1.0% concentration	Drug: ATX-101 1.0% concentration Injection into submental fat q4w
4: ATX-101 2.0%: Active Comparator ATX-101 2.0% concentration	Drug: ATX-101 2.0% concentration Injection into submental fat q4w

Eligibility

Ages Eligible for Study:	25 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Sufficient submental fat to warrant treatment with study medication
Male or female 26 to 65 years of age, inclusive
Good general health
Signed informed consent

Exclusion Criteria:

History of any treatment in the neck or chin area
Loose skin or prominent platysmal bands in the neck or chin area
Recent treatment with anticoagulants
Presence of clinically significant health problems

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00618722

Locations

Australia

Toorak, Australia

Carina Heights, Australia
Canada

Toronto, Canada
United Kingdom

London, United Kingdom

Sponsors and Collaborators

Kythera Biopharmecuticals

Investigators

Study Director:

Patricia Walker, M.D., Ph.D.

Kythera Biopharmaceuticals, Inc.

More Information

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
Health Authority:	Australia: National Health and Medical Research Council; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Canada: Health Canada

Keywords provided by Kythera Biopharmecuticals:

Submental fat

Study placed in the following topic categories:

Deoxycholic Acid

Additional relevant MeSH terms:

Therapeutic Uses
Cholagogues and Choleretics
Gastrointestinal Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009