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

Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of the Safety and Efficacy of ATX-101 (Sodium Deoxycholate for Injection) Given by Three Dosing Paradigms for the Reduction of Localized Subcutaneous Fat in the Submental Area

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).

Study Overview

• Status: Completed
• Conditions: Moderate or Severe Submental Fullness
• Intervention / Treatment: Drug: Placebo; Drug: Deoxycholic Acid Injection

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • Sydney, Australia, 2000
    • Investigational Site
  • Victoria
    • Toorak, Victoria, Australia, 3142
      • Investigational Site
• Canada
  • Ontario
    • Niagara Falls, Ontario, Canada, L2E 7H1
      • Investigational Site
    • Oakville, Ontario, Canada, L6J 7W5
      • Investigational Site
    • Toronto, Ontario, Canada, M4V 1R1
      • Investigational Site
    • Toronto, Ontario, Canada, M5S 3B4
      • Investigational Site
• United Kingdom
  • Manchester, United Kingdom, M68HD
    • Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Deoxycholic Acid Injection 0.2 mL/0.7 cm; 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; Formulated as an injectable solution containing deoxycholic acid at a concentration of 10 mg/mL.; Other Names: ATX-101
Placebo Comparator: Placebo 0.2 mL/0.7 cm; 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
Experimental: Deoxycholic Acid Injection 0.2 mL/1.0 cm; 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; Formulated as an injectable solution containing deoxycholic acid at a concentration of 10 mg/mL.; Other Names: ATX-101
Placebo Comparator: Placebo 0.2 mL/1.0 cm; 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
Experimental: Deoxycholic Acid Injection 0.4 mL/1.0 cm; 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; Formulated as an injectable solution containing deoxycholic acid at a concentration of 10 mg/mL.; Other Names: ATX-101
Placebo Comparator: Placebo 0.4 mL/1.0 cm; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Submental Fat (SMF) Rating Scale Score	The SMF rating scale 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 4 weeks after last treatment (up to 16 weeks after first dose)
Percentage of Participants With a Response in the Subject Global Improvement Rating	Participants were asked to rate their total improvement or worsening in the appearance and physical feeling of their chin and neck area since before they received study treatment, whether or not they believed it was due to study treatment or to any other cause. 0 = Very much worse, 1 = Much worse, 2 = Minimally worse, 3 = No change, 4 = Minimally improved, 5 = Much improved, 6 = Very much improved. Response is defined as any improvement, ie, a global improvement rating of 4, 5, or 6.	4 weeks after last treatment (up to 16 weeks after first dose)
Change From Baseline in Skin Laxity Rating	Skin laxity assessment was based on clinical evaluation and palpation of the submental area on the following scale: 1 = no laxity; 2 = minimal laxity; 3 = moderate laxity; 4 = very lax. A negative change from Baseline indicates improvement.	Baseline and Week 4, Week 8, Week 12, Week 16 (4 weeks after last treatment) and Week 24 (12 weeks after last treatment)
Change From Baseline in the Cervicomental Angle	The cervicomental angle was measured using a profile view photograph obtained at each visit. A goniometer was used to determine the angle. Cervicomental angle measurements less than 80 degrees are excluded, due to error in measurement.	Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)
Change From Baseline in Subject Satisfaction With Appearance Rating Scale	The Subject Satisfaction with Appearance Rating Scale assesses participants' satisfaction with their appearance in association with the face and chin on a 7-point scale from 0 to 6 where 0 = Extremely dissatisfied, 1 = Dissatisfied, 2 = Slightly dissatisfied, 3 = Neither satisfied nor dissatisfied, 4 = Slightly satisfied, 5 = Satisfied and 6 = Extremely satisfied. A positive change from Baseline indicates improvement.	Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)
Percentage of Participants With an SMF Response	Response is defined as a participant with at least a 1-grade improvement in SMF Rating Scale score at Week 16 from Baseline. The SMF rating scale 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.	Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)
Change From Baseline to Each Visit in Submental Fat (SMF) Rating Scale Score	The SMF rating scale 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 Week 4, Week 8, Week 12, Week 16 (4 weeks after last treatment) and Week 24 (12 weeks after last treatment)
Visual Analogue Scale Pain Intensity Rating	Participants rated pain associated with the submental area on a 100 mm horizontal axis ranging from 0 (no pain) to 100 (most severe pain possible)	Approximately 60 minutes after completion of each treatment session at Week 0, Week 4, Week 8 and Week 12

Collaborators and Investigators

• Sponsor: Kythera Biopharmaceuticals
• Investigators: Study Director: Frederick Beddingfield, III, M.D., Ph.D., Kythera Biopharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: February 8, 2008
• First Submitted That Met QC Criteria: February 8, 2008
• First Posted (Estimate): February 20, 2008

Study Record Updates

• Last Update Posted (Estimate): July 14, 2015
• Last Update Submitted That Met QC Criteria: June 17, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Gastrointestinal Agents; Cholagogues and Choleretics; Deoxycholic Acid
• Other Study ID Numbers: ATX-101-07-07; 2007-006303-21 (EudraCT Number)