Phase 3 Study of ATX-101 Versus Placebo for the Reduction of Localized Subcutaneous Fat in the Submental Area

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kythera Biopharmaceuticals
ClinicalTrials.gov Identifier:
NCT01542034
First received: February 24, 2012
Last updated: September 18, 2014
Last verified: September 2014
  Purpose

This is a Randomized, Double-Blind study evaluating the Safety and Efficacy of ATX-101 in the reduction of submental fat.


Condition Intervention Phase
Healthy
Drug: ATX-101
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Kythera Biopharmaceuticals:

Primary Outcome Measures:
  • Submental Fat Rating Scale [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]
    Submental Fat Rating Scale - A clinician's assessment of the amount of submental fat and a Subject Self Rating Scale.

  • Patient-Reported Submental Fat Rating Scale [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • MRI [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]
    Magnetic resonance imaging (MRI, which is an objective measure of the thickness and volume of fat in the treatment area.

  • To evaluate the effects of ATX-101 in the submental area using a Patient Reported Impact Scale [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]

Enrollment: 506
Study Start Date: February 2012
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo vehicle control
Drug: Placebo
A preservered PBS placebo, without ATX-101 will be administered monthly for up to 6 treatment sessions in the submental area.
Experimental: ATX-101 2 mg/cm2
ATX-101 2 mg/cm2
Drug: ATX-101
ATX-101 2mg/cm2 - ATX-101 will be administered monthly for up to 6 treatment sessions into the submental area.
Other Name: sodium deoxycholate injection

Detailed Description:

To evaluate the Safety and Efficacy of ATX-101 subcutaneous injections in the submental area, relative to placebo.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 forgo 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 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).
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01542034

  Show 35 Study Locations
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: NCT01542034     History of Changes
Other Study ID Numbers: ATX-101-11-22
Study First Received: February 24, 2012
Last Updated: September 18, 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
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014