Safety Study of ATX-101 (Deoxycholic Acid) in Subjects With Mild or Extreme Fullness of Submental Fat

NCT02035267 | Completed Phase 3 Results

• 1 other identifier: ATX-101-13-27
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 8

Brief Summary

The objectives of this study are to explore the safety and efficacy of subcutaneous injections of Deoxycholic Acid relative to placebo, in the submental area in patients with mild or extreme fullness of the submental fat and ratings of 1 or 4.

Conditions

Moderate to Severe Convexity of Submental Fat; Safety; Efficacy

Outcome Measures

Primary Outcomes (7)

• Percentage of Participants With at Least a 1-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on Both the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) Assessments

  The investigator evaluated the participant's chin and neck area using the Clinician-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst). The participant evaluated their chin and neck area using the Patient-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst).

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

• Percentage of Participants With at Least a 2-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on Both the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) Assessments

  The investigator evaluated the participant's chin and neck area using the Clinician-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst). The participant evaluated their chin and neck area using the Patient-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst).

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

• Percentage of Participants With at Least a 1-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS)

  The investigator evaluated the participant's chin and neck area using the CR-SMFRS 5-point scale where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst).

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

• Percentage of Participants With at Least a 2-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS)

  The investigator evaluated the participant's chin and neck area using the CR-SMFRS 5-point scale where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst).

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

• Percentage of Participants With at Least a 1-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on Patient-Reported Submental Fat Rating Scale (PR-SMFRS)

  The participant evaluated their chin and neck area using the PR-SMFRS 5-point scale where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst).

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

• Percentage of Participants With at Least a 2-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on Patient-Reported Submental Fat Rating Scale (PR-SMFRS)

  The participant evaluated their chin and neck area using the PR-SMFRS 5-point scale where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst).

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

• Change From Baseline in Submental Skin Laxity Grade Scale (SMSLG)

  The SMSLG is an integration of three features: skin wrinkling, adherence to underlying neck structures (bone and muscle) and redundancy (horizontal and vertical folds). Each grade (1=none, 2=mild, 3=moderate and 4=severe) defines the maximal allowed limit for skin wrinkling, adherence to underlying structures and redundancy.

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

Study Arms (4)

Placebo - Grade 1

PLACEBO COMPARATOR

Participants received placebo administered in 0.2 mL subcutaneous (SC) injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments. Participants With CR SMFRS Grade 1 (mild).

Drug: Placebo

ATX-101 deoxycholic acid injection - Grade 1

EXPERIMENTAL

Participants received deoxycholic acid 2 mg/cm\^2 administered in 0.2 mL SC injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments. Participants With Clinician-Reported Submental Fat Rating Scale (CR SMFRS) Grade 1 (mild).

Drug: Deoxycholic Acid

Placebo - Grade 4

PLACEBO COMPARATOR

Participants received placebo administered in 0.2 mL SC injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments. Participants With CR SMFRS Grade 4 (extreme).

Drug: Placebo

ATX-101 deoxycholic acid injection - Grade 4

EXPERIMENTAL

Participants received deoxycholic acid 2 mg/cm\^2 administered in 0.2 mL SC injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments. Participants with CR SMFRS Grade 4 (extreme).

Drug: Deoxycholic Acid

Interventions

Deoxycholic Acid DRUG

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

Also known as: ATX-101 deoxycholic acid injection

ATX-101 deoxycholic acid injection - Grade 1; ATX-101 deoxycholic acid injection - Grade 4

Placebo DRUG

Phosphate buffered saline placebo for injection.

Placebo - Grade 1; Placebo - Grade 4

Eligibility Criteria

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

You may qualify if:

• Male and female subjects, 18 to 65 years old
• Stable Body weight
• Body Mass Index (BMI) of ≤40.0 kg/m\^2
• Acceptable volume of submental fat graded by clinician
• Dissatisfaction with the submental area expressed by the subject
• Signed informed consent form (ICF)
• SMF ratings of 1 or 4

You may not qualify if:

• No prior intervention for submental fat (SMF) (eg, liposuction, surgery, or lipolytic agents)
• Presence of clinically significant health problems
• 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
• Body mass index ≤40 kg/m\^2

Sponsors & Collaborators

• Kythera Biopharmaceuticals: lead

Study Sites (8)

Unknown Facility

Newport Beach, California, United States

Location

Unknown Facility

San Francisco, California, United States

Location

Unknown Facility

West Hollywood, California, 90069, United States

Location

Unknown Facility

Boca Raton, Florida, United States

Location

Unknown Facility

Coral Gables, Florida, 33146, United States

Location

Unknown Facility

Glenn Dale, Maryland, 20769, United States

Location

Unknown Facility

Chestnut Hill, Massachusetts, 02467, United States

Location

Unknown Facility

St Louis, Missouri, United States

Location

MeSH Terms

Interventions

Deoxycholic Acid

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Beta Bowen
• Organization: Allergan, Inc

Bowen_Beta@allergan.com

1-714-246-4446

Study Officials

• Frederick Beddingfield, III, MD, PhD

  Sponsor GmbH

  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: January 12, 2014
• First Posted: January 14, 2014
• Study Start: January 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: February 17, 2020
• Results First Posted: February 17, 2020

Record last verified: 2020-01

Locations

US (8)