CompletedPhase 3

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

United States93 participantsStarted 2014-01

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Timeframe: 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

Timeframe: 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)

Timeframe: 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)

Timeframe: 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)

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

Trial details

NCT IDNCT02035267

SponsorKythera Biopharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-06

Results submitted2020-02-03

View on ClinicalTrials.gov More Moderate to Severe Convexity of Submental Fat trials

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Timeframe: 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)

Timeframe: 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)

Timeframe: 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)

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