None listed
Conditions
Brief summary
Deoxycholic acid, or deoxycholate, is a naturally occurring bile acid produced by the liver as one of several end products of sterol metabolism. In the human body, deoxycholate serves to solubilise dietary fats and facilitate their absorption. ATX-101 (sodium deoxycholate) is being developed by Kythera Biopharmaceuticals as a promising non-surgical treatment modality for several conditions characterised by unwanted or excessive fat deposition including, but not limited to, lipomas, lipodystrophy in patients with HIV infection, submental fat deposits (double chin) and other conditions for which liposuction or surgery are the current treatments. These surgeries are associated with the known risks of anaesthesia, infection, bleeding, bruising and scarring; the possibility of poor outcome, and the expected discomfort and “down-time” for the patient. Given the risks, which are well-established and documented, the growing popularity of these procedures is testament to the psychological importance of self image and to the benefit realised by subjects who seek them. The need for an approved, legitimate and minimally invasive medicinal product for reduction of localised fat deposits is substantiated by the significant and growing popularity of Lipostabil® and other unapproved extemporaneous mixtures of phosphatidylcholine/deoxycholate (PC/DC). The objectives of this study are (1) to determine the safety and tolerability of ATX-101 injections at three concentrations relative to placebo; and (2) to evaluate the potential efficacy of ATX-101, relative to placebo, in reducing submental fat and thereby achieve improvement as judged by the Investigator and participant.
Interventions
Four arm study -Arm a: sodium deoxycholate injections of 0.5% Arm b: sodium deoxycholate injections of 1.0% Arm c: sodium deoxycholate injections of 2.0% Arm d: placebo. Subjects will receive up to 4 treatments of up to 24 injections (0.2mL each, or a maximum volume of approximately 4.8mL) per treatment (depending on size and configuration of the submental fat) which will be given at four week intervals.
Sponsors
Kythera Biopharmaceuticals Inc
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
25 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
Submental fat that is considered undesirable by the subject and graded by the investigator as 2 or 3 using the Submental Fat Rating Scale Males or nonpregnant, nonlactating females who are aged 25 to 55 years, inclusive, on the date of randomization. Females of childbearing potential must have a negative pregnancy test within 28 days before randomization and must agree to practice adequate contraception, in the judgment of the investigator, during the course of the trial.Body mass index of less than 35.0 kg/M2 determined within 28 days before randomization.History of maintenance of a stable body weight, in the judgment of the investigator, for at least 6 months before randomization.The subject is expected to comply with and understand the visit schedule and all of the protocol-specified tests and procedures.The subject is medically able to undergo the administration of study material as determined by clinical and laboratory evaluations obtained within 28 days before randomization including, but not limited to, liver function and creatinine test results that are in the normal range for the laboratory.Signed informed consent obtained before any study-specific procedure is conducted.
Exclusion criteria
History of any intervention (e.g., liposuction, botulinum toxin injections) or trauma associated with the chin or neck areas.Loose skin in the neck or chin area for which reduction in submental fat may, in the judgment of the investigator, result in a cosmetically unacceptable outcome.Prominent platysmal bands at rest that interfere with the evaluation of submental fat.Evidence of any cause of enlargement in the submental area (e.g., thyroid enlargement, cervical adenopathy) other than localized submental fat.Fitzpatrick Skin Type IV, V, or VI (Appendix B).Currently on, or considering starting, a weight reduction regimen.History of cholecystectomy or current liver disease (e.g., acute or chronic hepatitis, cirrhosis). Presence of any coagulation disorder.Any medical condition (e.g., respiratory, cardiovascular, neurological disease, uncontrolled hypertension, thyroid dysfunction), that would interfere with the assessment of safety or efficacy in this trial or would compromise the ability of the subject to undergo study procedures or to give informed consent.History of treatment with deoxycholate-containing products (including amphotericin formulations containing deoxycholate or phosphatidylcholine/deoxycholate formulations).Treatment with fish oil, aspirin, or nonsteroidal anti-inflammatory agents (NSAIDS), except acetaminophen, within seven days before randomization, or any anticipated need for agents with anticoagulative effects during the course of the trial.Treatment with oral anticoagulants (e.g., warfarin or aspirin greater than 81 mg/day) within 28 days before randomization.Treatment with bile acid sequestrants (e.g., cholestyramine or colestipol) within 28 days before randomization.Treatment with radio frequency, laser procedures, chemical peel, or dermal fillers in the neck or chin area within 12 months before randomization.History of sensitivity to any components of the study material or to topical or local anesthetics (e.g., lidocaine, benzocaine, novocaine).Previous randomization into this trial.Treatment with an investigational device or agent within 30 days before randomization.
Outcome results
None listed