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

A Multicenter, Double-blind, Placebo-controlled Safety Study of ATX-101 (Deoxycholic Acid) Injection for the Reduction of Localized Subcutaneous Fat in the Submental Area in Subjects With Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) Grade 1 or CR-SMFRS Grade 4

Sponsors

Lead Sponsor: Kythera Biopharmaceuticals

Source Kythera Biopharmaceuticals
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.

Overall Status Completed
Start Date 2014-01-01
Completion Date 2015-06-01
Primary Completion Date 2015-06-01
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
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 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 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) 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) 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) 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) Baseline and up to Week 32 (12 weeks after last treatment)
Change From Baseline in Submental Skin Laxity Grade Scale (SMSLG) Baseline and up to Week 32 (12 weeks after last treatment)
Enrollment 93
Condition
Intervention

Intervention Type: Drug

Intervention Name: Deoxycholic Acid

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

Other Name: ATX-101 deoxycholic acid injection

Intervention Type: Drug

Intervention Name: Placebo

Description: Phosphate buffered saline placebo for injection.

Eligibility

Criteria:

Inclusion Criteria: - 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 Exclusion Criteria: - 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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

65 Years

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Frederick Beddingfield, III, MD, PhD Study Director Sponsor GmbH
Location
Facility:
| Newport Beach, California, United States
| San Francisco, California, United States
| West Hollywood, California, 90069, United States
| Boca Raton, Florida, United States
| Coral Gables, Florida, 33146, United States
| Glenn Dale, Maryland, 20769, United States
| Chestnut Hill, Massachusetts, 02467, United States
| Saint Louis, Missouri, United States
Location Countries

United States

Verification Date

2020-01-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Number Of Arms 4
Arm Group

Label: Placebo - Grade 1

Type: Placebo Comparator

Description: 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).

Label: ATX-101 deoxycholic acid injection - Grade 1

Type: Experimental

Description: 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).

Label: Placebo - Grade 4

Type: Placebo Comparator

Description: 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).

Label: ATX-101 deoxycholic acid injection - Grade 4

Type: Experimental

Description: 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).

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Research News