ATX-101 Submental Fat (SMF) Magnetic Resonance Imaging (MRI) and Subject-reported Outcome Measures Study
This study has been completed.
Sponsor:
Kythera Biopharmaceuticals
Information provided by (Responsible Party):
Kythera Biopharmaceuticals
ClinicalTrials.gov Identifier:
NCT01032889
First received: December 10, 2009
Last updated: April 4, 2012
Last verified: April 2012
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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
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 | |
| John Joseph, MD | |
| Beverly Hills, California, United States, 90210 | |
| Mark Rubin, MD | |
| Beverly Hills, California, United States, 90212 | |
| 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: | April 4, 2012 |
| 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 Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013