Phase 3 Study of Deoxycholic Acid Injection (ATX-101) Versus Placebo for the Reduction of Localized Subcutaneous Fat in the Submental Area

Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of ATX-101 (Sodium Deoxycholate Injection) Versus Placebo for the Reduction of Localized Subcutaneous Fat in the Submental Area

Sponsors

Lead Sponsor: Kythera Biopharmaceuticals

Source Kythera Biopharmaceuticals
Brief Summary

To evaluate the safety and efficacy of deoxycholic acid injection in the reduction of submental fat (fat below the chin).

Overall Status Completed
Start Date February 2012
Completion Date August 2013
Primary Completion Date May 2013
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Percentage of Participants Who Achieved a Composite 1-grade Response Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)
Percentage of Participants Who Achieved a Composite 2-grade Response Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)
Secondary Outcome
Measure Time Frame
Percentage of Participants With a Magnetic Resonance Imaging (MRI) Response Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)
Change From Baseline in Patient-Reported Submental Fat Impact Scale (PR-SMFIS) Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)
Enrollment 506
Condition
Intervention

Intervention Type: Drug

Intervention Name: Deoxycholic acid injection

Description: Formulated as an injectable solution containing deoxycholic acid at a concentration of 10 mg/mL.

Arm Group Label: Deoxycholic Acid Injection

Intervention Type: Drug

Intervention Name: Placebo

Description: Phosphate buffered saline placebo for injection

Arm Group Label: Placebo

Eligibility

Criteria:

Inclusion Criteria:

1. Submental fat graded by the investigator as 2 or 3 using the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and graded by the subject as 2 or 3 using the Patient-Reported Submental Fat Rating Scale (PR-SMFRS) as determined on Visit 1 (within 28 days before randomization).

2. Dissatisfaction with the submental area expressed by the subject as a rating of 0, 1, or 2 using the Subject Self Rating Scale (SSRS) as determined on Visit 1 (within 28 days before randomization).

3. Males and nonpregnant, nonlactating females 18 to 65 years of age, inclusive, on the day of randomization (Visit 2). Females of childbearing potential must have a negative human chorionic gonadotropin (hCG) test result within 28 days before Visit 2 and agree to practice adequate contraception, in the judgment of the investigator, during the course of the study. Females of childbearing potential who are not sexually active need not practice contraception.

4. History of stable body weight, in the judgment of the investigator, for at least 6 months before randomization.

5. Expected to understand and agree to comply with the visit schedule and all protocol-specified tests and procedures and agreement by the subject to refrain from making significant changes, in the judgment of the investigator, to his or her dietary or exercise habits during the course of the subject's participation.

6. Agreement to forego any treatment or behavior (e.g., unshaven facial hair) during the subject's participation in the study that may affect the assessments of the submental area.

7. Medically able to undergo the administration of study material determined by clinical and laboratory tests obtained within 28 days before randomization for which the investigator identified no clinically significant abnormality.

8. Signed informed consent obtained before any study-specific procedure is performed.

Exclusion Criteria:

1. History of any intervention to treat submental fat (e.g., liposuction, surgery, or lipolytic agents).

2. History of trauma associated with the chin or neck areas that in the judgment of the investigator may affect evaluation of safety or efficacy of treatment.

3. A Submental Skin Laxity Grade (SMSLG) of 4 or other anatomical feature (e.g., predominant subplatysmal fat, loose skin in the neck or chin area, prominent platysmal bands), as assessed within 28 days before randomization, for which reduction in submental fat may, in the judgment of the investigator, result in an aesthetically unacceptable outcome.

4. Evidence of any cause of enlargement in the submental area (e.g., thyroid enlargement, cervical adenopathy) other than localized submental fat.

5. Body mass index of > 40.0 as determined on Visit 1.

6. History or current symptoms of dysphagia.

7. A result on coagulation tests (PT, PTT) obtained within 28 days before randomization that indicates the presence of any clinically significant bleeding disorder.

8. Any medical condition (e.g., respiratory, cardiovascular, hepatic, neurological disease, or thyroid dysfunction) that would interfere with assessment of safety or efficacy or compromise the subject's ability to undergo study procedures or give informed consent.

9. Treatment with radio frequency, laser procedures, chemical peels, or dermal fillers in the neck or chin area within 12 months before randomization.

10. Treatment with botulinum toxin injections in the neck or chin area within 6 months before randomization.

11. History of sensitivity to any components of the study material

12. History of sensitivity to topical or local anesthetics (e.g., lidocaine, benzocaine, procaine).

13. Previous randomization in this study or previous participation in a Kythera-sponsored ATX 101 trial.

14. Treatment with an investigational device or agent within 30 days before randomization.

15. For centers selected to conduct magnetic resonance imaging (MRI) evaluations, any subject with the presence of any condition that would render a subject unsuitable for MRI evaluation (e.g., claustrophobia), or metals in the body that would interfere with MRI acquisition (e.g., nonremovable metal appliances in the mouth such as silver or gold caps, pacemakers, metal joints).

Gender: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Frederick Beddingfield, MD, PhD Study Director Kythera Biopharmaceuticals, Inc
Location
Facility:
Investigational Site | Birmingham, Alabama, 35205, United States
Investigational Site | Beverly Hills, California, 90210, United States
Investigational Site | Beverly Hills, California, 90212, United States
Investigational Site | Irvine, California, 92697, United States
Investigational Site | Los Angeles, California, 90201, United States
Investigational Site | Oceanside, California, 92056, United States
Investigational Site | San Diego, California, 92121, United States
Investigational Site | SanDiego, California, 92117, United States
Investigational Site | New Haven, Connecticut, 06511, United States
Investigational Site | Washington, District of Columbia, 20037, United States
Investigational Site | Miami Beach, Florida, 33140, United States
Investigational Site | West Palm Beach, Florida, 33401, United States
Investigational Site | Atlanta, Georgia, 30342, United States
Investigational Site | Snellville, Georgia, 30078, United States
Investigational Site | Arlington, Illinois, 60005, United States
Investigational Site | Chicago, Illinois, 60611, United States
Investigational Site | Evansville, Indiana, 47713, United States
Investigational Site | Louisville, Kentucky, 40217, United States
Investigational Site | Glen Dale, Maryland, 20769, United States
Investigational Site | Hunt Valley, Maryland, 21030, United States
Investigational Site | Rockville, Maryland, 20850, United States
Investigational Site | West Bloomfield, Michigan, 48322, United States
Investigational Site | Fridley, Minnesota, 55432, United States
Investigational Site | Omaha, Nebraska, 68144, United States
Investigational Site | New York, New York, 10028, United States
Investigational Site | New York, New York, 10029, United States
Investigational Site | Charlotte, North Carolina, 28207, United States
Investigational Site | Nashville, Tennessee, 37203, United States
Investigational Site | Nashville, Tennessee, 37215, United States
Investigational Site | Charlottesville, Virginia, 22911, United States
Investigational Site | Spokane, Washington, 99204, United States
Investigational Site | Peterborough, Ontario, K9J 1Z2, Canada
Investigational Site | Toranto, Ontario, M5S 3B4, Canada
Investigational Site | Toronto, Ontario, M5R 3N8, Canada
Investigational Site | Montreal, Quebec, H2K 4L5, Canada
Investigational Site | Vancouver, B.C., V5Z4E1, Canada
Location Countries

Canada

United States

Verification Date

May 2015

Responsible Party

Type: Sponsor

Has Expanded Access No
Number Of Arms 2
Arm Group

Label: Deoxycholic Acid Injection

Type: Experimental

Description: Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.

Label: Placebo

Type: Placebo Comparator

Description: Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.

Acronym REFINE-1
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov