Phase 2 Study of Deoxycholic Acid Injection (ATX-101) for the Reduction of Submental Fat

NCT00618618 | Completed Phase 2 Results

• 2 other identifiers: ATX-101-07-072007-006303-21
• Study Type: interventional
• Target: 73
• Locations: 3 countries
• Sites: 7

Brief Summary

Phase 2 trial to evaluate the safety and potential efficacy of one concentration of deoxycholic acid injection, given in three dosing paradigms, compared to placebo for the reduction of submental fat (fat beneath the chin).

Conditions

Moderate or Severe Submental Fullness

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Adverse Events

  The investigator determined the relationship of each adverse event to the administration of study drug. Severity of adverse events was determined using the following scale: * Mild: The participant is aware of a sign or symptom, but it is easily tolerated * Moderate: Discomfort or interference with usual activity * Severe: Incapacitating, with inability to engage in usual activity. A serious AE (SAE) was defined as an event that may constitute a significant medical hazard or side-effect, regardless of the investigator or sponsor's opinion regarding relatedness to study material. Serious events included, but were not limited to, any event that: * was fatal * was life-threatening * required inpatient hospitalization or prolongation of existing hospitalization * resulted in persistent or significant disability/incapacity * was a congenital anomaly/birth defect * other significant medical hazard

  From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).

• Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, Weight, Vital Signs, and Physical Examinations

  From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).

Secondary Outcomes (8)

• Change From Baseline in Submental Fat (SMF) Rating Scale Score

  Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)

• Change From Baseline in Subject Satisfaction With Appearance Rating Scale

  Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)

• Percentage of Participants With a Response in the Subject Global Improvement Rating

  4 weeks after last treatment (up to 16 weeks after first dose)

• Percentage of Participants With an SMF Response

  Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)

• Change From Baseline in Skin Laxity Rating

  Baseline and Week 4, Week 8, Week 12, Week 16 (4 weeks after last treatment) and Week 24 (12 weeks after last treatment)

Study Arms (6)

Deoxycholic Acid Injection 0.2 mL/0.7 cm

EXPERIMENTAL

Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.

Drug: Deoxycholic Acid Injection

Placebo 0.2 mL/0.7 cm

PLACEBO COMPARATOR

Participants received placebo administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.

Drug: Placebo

Deoxycholic Acid Injection 0.2 mL/1.0 cm

EXPERIMENTAL

Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.

Drug: Deoxycholic Acid Injection

Placebo 0.2 mL/1.0 cm

PLACEBO COMPARATOR

Participants received placebo administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.

Drug: Placebo

Deoxycholic Acid Injection 0.4 mL/1.0 cm

EXPERIMENTAL

Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.

Drug: Deoxycholic Acid Injection

Placebo 0.4 mL/1.0 cm

PLACEBO COMPARATOR

Participants received placebo administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 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

Deoxycholic Acid Injection 0.2 mL/0.7 cm; Deoxycholic Acid Injection 0.2 mL/1.0 cm; Deoxycholic Acid Injection 0.4 mL/1.0 cm

Placebo DRUG

Placebo 0.2 mL/0.7 cm; Placebo 0.2 mL/1.0 cm; Placebo 0.4 mL/1.0 cm

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Submental fat that was considered undesirable by the subject and graded by the investigator as 2 or 3 using the submental fat (SMF) rating scale
• Good general health
• Signed informed consent

You may not qualify if:

• History of any treatment in the neck or chin area
• Loose skin or prominent platysmal bands in the neck or chin area
• Recent treatment with anticoagulants
• Presence of clinically significant health problems

Sponsors & Collaborators

• Kythera Biopharmaceuticals: lead

Study Sites (7)

Investigational Site

Toorak, Victoria, 3142, Australia

Location

Investigational Site

Sydney, 2000, Australia

Location

Investigational Site

Niagara Falls, Ontario, L2E 7H1, Canada

Location

Investigational Site

Oakville, Ontario, L6J 7W5, Canada

Location

Investigational Site

Toronto, Ontario, M4V 1R1, Canada

Location

Investigational Site

Toronto, Ontario, M5S 3B4, Canada

Location

Investigational Site

Manchester, M68HD, United Kingdom

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, III, M.D., Ph.D.

  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: February 8, 2008
• First Posted: February 20, 2008
• Study Start: April 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: July 14, 2015
• Results First Posted: June 15, 2015

Record last verified: 2015-06

Locations

GB (1); AU (2); CA (4)