CompletedPhase 2

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

Australia, Canada, United Kingdom73 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 range

25 Years – 65 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

Who can participate

Age range

25 Years – 65 Years

Sex

ALL

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

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).