CompletedPhase 2

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

Australia, Canada73 participantsStarted 2008-04

Plain-language summary

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).

Who can participate

Age range25 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: * 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

What they're measuring

Number of Participants With Adverse Events

Timeframe: 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

Timeframe: From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).

Trial details

NCT IDNCT00618618

SponsorKythera Biopharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2008-12

Results submitted2015-05-28

View on ClinicalTrials.gov More Moderate or Severe Submental Fullness trials