Phase 3 N=93 Randomized Double-blind Treatment

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

Moderate to Severe Convexity of Submental Fat · Safety · Efficacy

Bottom Line

View on ClinicalTrials.gov: NCT02035267 ↗

Enrolled (actual)

Serious AEs

2.2%

Results posted

Feb 2020

Primary outcome: Primary: 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 — 61.3; 6.7; 89.3; 13.3 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Deoxycholic Acid (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Kythera Biopharmaceuticals
Primary completion: Jun 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY 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	61.3; 6.7; 89.3; 13.3	—
PRIMARY 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	42.9; 0	—
PRIMARY 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)	74.2; 20.0; 96.4; 26.7	—
PRIMARY 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)	71.4; 13.3	—
PRIMARY 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)	67.7; 33.3; 89.3; 46.7	—
PRIMARY 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)	60.7; 20.0	—
PRIMARY Change From Baseline in Submental Skin Laxity Grade Scale (SMSLG)	-0.3; -0.1; -0.3; -0.2	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02035267). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.