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

NCT01542034 | Completed Phase 3 Results

• 1 other identifier: ATX-101-11-22
• Study Type: interventional
• Target: 506
• Locations: 2 countries
• Sites: 36

Brief Summary

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

Conditions

Moderate or Severe Submental Fullness

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants Who Achieved a Composite 1-grade Response

  A composite 1-grade response is defined as at least a 1-grade improvement from Baseline on both the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) 12 weeks after the last treatment. The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme. The PR-SMFRS is based on the participant's response to the question "How much fat do you have under your chin right now?" answered on a 5-point ordinal scale (0-4) with 0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat.

  Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)

• Percentage of Participants Who Achieved a Composite 2-grade Response

  A composite 2-grade response is defined as at least a 2-grade improvement from Baseline on both the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) 12 weeks after the last treatment. The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme. The PR-SMFRS is based on the participant's response to the question "How much fat do you have under your chin right now?" answered on a 5-point ordinal scale (0-4) with 0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat.

  Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)

Secondary Outcomes (2)

• 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)

Study Arms (2)

Deoxycholic Acid Injection

EXPERIMENTAL

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.

Drug: Deoxycholic acid injection

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Deoxycholic acid injection DRUG

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

Also known as: ATX-101, Kybella

Deoxycholic Acid Injection

Placebo DRUG

Phosphate buffered saline placebo for injection

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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).
• 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.
• History of stable body weight, in the judgment of the investigator, for at least 6 months before randomization.
• 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.
• 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.
• 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.
• Signed informed consent obtained before any study-specific procedure is performed.

You may not qualify if:

• History of any intervention to treat submental fat (e.g., liposuction, surgery, or lipolytic agents).
• 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.
• 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.
• Evidence of any cause of enlargement in the submental area (e.g., thyroid enlargement, cervical adenopathy) other than localized submental fat.
• Body mass index of \> 40.0 as determined on Visit 1.
• History or current symptoms of dysphagia.
• A result on coagulation tests (PT, PTT) obtained within 28 days before randomization that indicates the presence of any clinically significant bleeding disorder.
• 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.
• Treatment with radio frequency, laser procedures, chemical peels, or dermal fillers in the neck or chin area within 12 months before randomization.
• Treatment with botulinum toxin injections in the neck or chin area within 6 months before randomization.
• History of sensitivity to any components of the study material
• History of sensitivity to topical or local anesthetics (e.g., lidocaine, benzocaine, procaine).
• Previous randomization in this study or previous participation in a Kythera-sponsored ATX 101 trial.
• Treatment with an investigational device or agent within 30 days before randomization.
• 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).

Sponsors & Collaborators

• Kythera Biopharmaceuticals: lead

Study Sites (36)

Investigational Site

Birmingham, Alabama, 35205, United States

Location

Investigational Site

Beverly Hills, California, 90210, United States

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Beverly Hills, California, 90212, United States

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Irvine, California, 92697, United States

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Los Angeles, California, 90201, United States

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Oceanside, California, 92056, United States

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San Diego, California, 92117, United States

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San Diego, California, 92121, United States

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New Haven, Connecticut, 06511, United States

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Washington D.C., District of Columbia, 20037, United States

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Miami Beach, Florida, 33140, United States

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West Palm Beach, Florida, 33401, United States

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Atlanta, Georgia, 30342, United States

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Snellville, Georgia, 30078, United States

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Arlington, Illinois, 60005, United States

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Chicago, Illinois, 60611, United States

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Evansville, Indiana, 47713, United States

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Louisville, Kentucky, 40217, United States

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Glenn Dale, Maryland, 20769, United States

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Hunt Valley, Maryland, 21030, United States

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Rockville, Maryland, 20850, United States

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West Bloomfield, Michigan, 48322, United States

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Fridley, Minnesota, 55432, United States

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Omaha, Nebraska, 68144, United States

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New York, New York, 10028, United States

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New York, New York, 10029, United States

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Charlotte, North Carolina, 28207, United States

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Nashville, Tennessee, 37203, United States

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Nashville, Tennessee, 37215, United States

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Charlottesville, Virginia, 22911, United States

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Spokane, Washington, 99204, United States

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Peterborough, Ontario, K9J 1Z2, Canada

Location

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Toronto, Ontario, M5R 3N8, Canada

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Toronto, Ontario, M5S 3B4, Canada

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Montreal, Quebec, H2K 4L5, Canada

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Vancouver, B.C., V5Z4E1, Canada

Location

MeSH Terms

Conditions

Lymphoma, Follicular

Interventions

Deoxycholic Acid

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cholic Acids; Bile Acids and Salts; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholanes

Results Point of Contact

• Title: Clinical Trial Disclosure
• Organization: Kythera

clinical_trials@kythera.com

Study Officials

• Frederick Beddingfield, MD, PhD

  Kythera Biopharmaceuticals, Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2012
• First Posted: March 1, 2012
• Study Start: February 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: August 1, 2013
• Last Updated: June 15, 2015
• Results First Posted: June 15, 2015

Record last verified: 2015-05

Locations

CA (5); US (31)