ATX-101 Submental Fat (SMF) Magnetic Resonance Imaging (MRI) and Subject-reported Outcome Measures Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kythera Biopharmaceuticals
ClinicalTrials.gov Identifier:
NCT01032889
First received: December 10, 2009
Last updated: May 30, 2014
Last verified: May 2014
  Purpose

Evaluation of the safety, tolerability and efficacy of ATX-101 in the reduction of submental fat.


Condition Intervention Phase
Healthy
Drug: Placebo
Drug: ATX-101
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multicenter, Randomized, Double-blind, Placebo-controlled Study of ATX-101 (Sodium Deoxycholate Injection) Versus Placebo for the Reduction of Subcutaneous Fat in the Submental Area (SMF) Using MRI and a Battery of Clinician- and Subject-reported Measurements

Resource links provided by NLM:


Further study details as provided by Kythera Biopharmaceuticals:

Primary Outcome Measures:
  • Submental Fat Rating Scale, which is a clinician's assessment of the amount of submental fat. [ Time Frame: Three months after cessation of treatment. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Magnetic resonance imaging (MRI, which is an objective measure of the thickness and volume of fat in the treatment area. [ Time Frame: Three Months after cessation of treatment. ] [ Designated as safety issue: No ]

Enrollment: 129
Study Start Date: October 2009
Study Completion Date: March 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
placebo vehicle
Drug: Placebo
Placebo control
Other Name: Placebo vehicle
Experimental: ATX-101 1mg/cm2
ATX-101
Drug: ATX-101
ATX-101
Other Name: sodium deoxycholate injection
Experimental: ATX-101 2 mg/cm2
ATX-101
Drug: ATX-101
ATX-101 2mg/cm2
Other Name: sodium deoxycholate injection

Detailed Description:

Multicenter, randomized, double-blind, placebo-controlled study of ATX-101 (sodium deoxycholate injection) versus placebo for the reduction of subcutaneous fat in the submental area (SMF) using MRI and a battery of clinician- and subject-reported measurements.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Sufficient submental fat
  • Dissatisfaction with submental area
  • History of stable body weight
  • Presence of any medical or other condition that could affect subject safety or evaluation of efficacy
  • Signed informed consent

Exclusion Criteria:

  • History of any medical or other condition that could affect subject safety or evaluation of efficacy
  • Previous intervention in the submental area
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01032889

Locations
United States, Alabama
Gary Monheit, MD
Birmingham, Alabama, United States, 35051
United States, California
Mark Rubin, MD
Beverly Hills, California, United States, 90212
John Joseph, MD
Beverly Hills, California, United States, 90210
Bryant Toth, MD
San Francisco, California, United States, 94115
United States, Illinois
Ashish Bhatia, MD
Downers Grove, Illinois, United States, 60515
United States, Massachusetts
Jeffrey Dover, MD
Chestnut Hill, Massachusetts, United States, 02467
United States, Minnesota
Steven Kempers, MD
Fridley, Minnesota, United States, 55432
United States, Missouri
Leroy Young, MD
St. Louis, Missouri, United States, 63141
United States, Nebraska
Joel Schlessinger, MD
Omaha, Nebraska, United States, 68144
United States, Texas
Jeffrey Adelglass, MD
Plano, Texas, United States, 75093
Sponsors and Collaborators
Kythera Biopharmaceuticals
Investigators
Study Director: Patricia Walker, M.D. Kythera Biopharmaceuticals, Inc..
  More Information

No publications provided

Responsible Party: Kythera Biopharmaceuticals
ClinicalTrials.gov Identifier: NCT01032889     History of Changes
Other Study ID Numbers: ATX-101-09-15
Study First Received: December 10, 2009
Last Updated: May 30, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Kythera Biopharmaceuticals:
Healthy Subjects

Additional relevant MeSH terms:
Deoxycholic Acid
Cholagogues and Choleretics
Gastrointestinal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014