Phase 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:	NCT00618618

Purpose

Phase 2 trial to evaluate the safety and potential efficacy of one concentration of ATX-101, given in two dosing paradigms, compared to placebo for the reduction of submental fat.

Condition	Intervention	Phase
Reduction of Submental Fat	Drug: Placebo vehicle Drug: ATX-101 1.0% concentration Drug: ATX-101 1.0% Concentration	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, 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of ATX-101 (Sodium Deoxycholate for Injection) Given by Three Dosing Paradigms for the Reduction of Localized 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:	60
Study Start Date:	February 2008
Estimated Study Completion Date:	January 2009
Estimated Primary Completion Date:	November 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 1.0%: Active Comparator	Drug: ATX-101 1.0% concentration Injection into submental fat q4w
3: ATX-101 1.0%: Active Comparator	Drug: ATX-101 1.0% Concentration Injection into submental fat q4w
4: ATX-101 1.0%: Active Comparator	Drug: ATX-101 1.0% 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: NCT00618618

Locations

Australia

Sydney, Australia
Canada

Toronto, Canada
United Kingdom

Manchester, 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-101-07-07
Study First Received:	February 8, 2008
Last Updated:	July 8, 2008
ClinicalTrials.gov Identifier:	NCT00618618
Health Authority:	Australia: National Health and Medical Research Council; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Canada: Health Canada

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