Clinical trial NCT01542034: Phase 3 Study of Deoxycholic Acid Injection (ATX-101) Versus Placebo for the Reduction of Localized Subcutaneous Fat in the Submental Area
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Moderate or Severe Submental Fullness
Lead sponsor: Kythera Biopharmaceuticals
Sponsor class: INDUSTRY
First posted: 2012-03-01
Enrollment: 506
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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).

Primary outcomes:
measure: Percentage of Participants Who Achieved a Composite 1-grade Response
timeFrame: Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)
measure: Percentage of Participants Who Achieved a Composite 2-grade Response
timeFrame: Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)
Secondary outcomes:
measure: Percentage of Participants With a Magnetic Resonance Imaging (MRI) Response
timeFrame: Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)
measure: Change From Baseline in Patient-Reported Submental Fat Impact Scale (PR-SMFIS)
timeFrame: Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Investigational Site
state: Alabama
city: Beverly Hills
country: United States
facility: Investigational Site
state: California
city: Beverly Hills
country: United States
facility: Investigational Site
state: California
city: Irvine
country: United States
facility: Investigational Site
state: California
city: Los Angeles
country: United States
facility: Investigational Site
state: California
city: Oceanside
country: United States
facility: Investigational Site
state: California
city: San Diego
country: United States
facility: Investigational Site
state: California
city: SanDiego
country: United States
facility: Investigational Site
state: California
city: New Haven
country: United States
facility: Investigational Site
state: Connecticut
city: Washington
country: United States
facility: Investigational Site
state: District of Columbia
city: Miami Beach
country: United States
facility: Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Investigational Site
state: Georgia
city: Snellville
country: United States
facility: Investigational Site
state: Georgia
city: Arlington
country: United States
facility: Investigational Site
state: Illinois
city: Chicago
country: United States
facility: Investigational Site
state: Illinois
city: Evansville
country: United States
facility: Investigational Site
state: Indiana
city: Louisville
country: United States
facility: Investigational Site
state: Kentucky
city: Glen Dale
country: United States
facility: Investigational Site
state: Maryland
city: Hunt Valley
country: United States
facility: Investigational Site
state: Maryland
city: Rockville
country: United States
facility: Investigational Site
state: Maryland
city: West Bloomfield
country: United States
facility: Investigational Site
state: Michigan
city: Fridley
country: United States
facility: Investigational Site
state: Minnesota
city: Omaha
country: United States
facility: Investigational Site
state: Nebraska
city: New York
country: United States
facility: Investigational Site
state: New York
city: New York
country: United States
facility: Investigational Site
state: New York
city: Charlotte
country: United States
facility: Investigational Site
state: North Carolina
city: Nashville
country: United States
facility: Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Investigational Site
state: Tennessee
city: Charlottesville
country: United States
facility: Investigational Site
state: Virginia
city: Spokane
country: United States
facility: Investigational Site
state: Washington
city: Peterborough
country: Canada
facility: Investigational Site
state: Ontario
city: Toranto
country: Canada
facility: Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: Investigational Site
state: Quebec
city: Vancouver, B.C.
country: Canada
facility: Investigational Site
Study officials:
affiliation: Kythera Biopharmaceuticals, Inc
name: Frederick Beddingfield, MD, PhD
role: STUDY_DIRECTOR
References: