Deoxycholic Acid Injection Submental Fat (SMF) Magnetic Resonance Imaging (MRI) and Subject-reported Outcome Measures Study

NCT01032889 | Completed Phase 2 Results

• 1 other identifier: ATX-101-09-15
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 10

Brief Summary

Evaluation of the safety, tolerability 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 (3)

• Change From Baseline in Clinician-Reported Submental Fat Rating Scale Scores

  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. A negative change from Baseline indicates improvement.

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

• Change From Baseline in Patient-Reported Submental Fat Scale Rating Scale (PR-SMFRS)

  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. A negative change from Baseline indicates improvement.

  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)

  The PR-SMFIS assesses the impact of submental fat on self-perception of 6 emotional and visual characteristics related to the appearance of submental fullness (unhappy, bothered, self-conscious, embarrassed, look older, and look overweight) as evaluated by the participant. Each item is rated on an 11-point numeric scale from 0 to 10. Scores for the 6 items were averaged to generate a PR-SMFIS total scale score ranging from 0 to 10 where 0 is a positive outcome and 10 is a negative outcome. A negative change from Baseline indicates improvement.

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

Secondary Outcomes (2)

• Change From Baseline in Submental Fat Volume

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

• Change From Baseline in Submental Fat Thickness

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

Study Arms (3)

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

Deoxycholic acid Injection 1 mg/cm²

EXPERIMENTAL

Participants received deoxycholic acid 1 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

Deoxycholic acid Injection 2 mg/cm²

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

Interventions

Deoxycholic acid injection DRUG

Also known as: ATX-101, Kybella

Deoxycholic acid Injection 1 mg/cm²; Deoxycholic acid Injection 2 mg/cm²

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:

• Moderate or severe submental fat
• Dissatisfaction with submental area
• History of stable body weight
• Signed informed consent

You may not qualify if:

• Any medical or other condition that would affect subject safety or evaluation of efficacy
• Previous intervention in the submental area

Sponsors & Collaborators

• Kythera Biopharmaceuticals: lead

Study Sites (10)

Investigational Site

Birmingham, Alabama, 35205, United States

Location

Investigational Site

Beverly Hills, California, 90210, United States

Location

Investigational Site

Beverly Hills, California, 90212, United States

Location

Investigational Site

San Francisco, California, 94115, United States

Location

Investigational Site

Naperville, Illinois, 60563, United States

Location

Investigational Site

Chestnut Hill, Massachusetts, 02467, United States

Location

Investigational Site

Fridley, Minnesota, 55432, United States

Location

Investigational Site

St Louis, Missouri, 63141, United States

Location

Investigational Site

Omaha, Nebraska, 68144, United States

Location

Investigational Site

Plano, Texas, 75093, United States

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 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2009
• First Posted: December 16, 2009
• Study Start: December 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: June 15, 2015
• Results First Posted: June 15, 2015

Record last verified: 2015-05

Locations

US (10)