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Trial registered on ANZCTR


Registration number
ACTRN12607000626460
Ethics application status
Not yet submitted
Date submitted
4/12/2007
Date registered
6/12/2007
Date last updated
27/02/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase 2 Study of ATX 101 (Sodium Deoxycholate for injection) Given by Three Dosing Paradigms for the Reduction of Submental Fat (Double Chin).
Scientific title
Phase 2 Multicentre Randomised, Double-Blind, Placebo controlled Parallel- group Study of the Safety and Efficacy of ATX 101 (Sodium Deoxycholate for injection) Given by Three Dosing Paradigms for the Reduction of Localized Subcutaneous Fat in the Submental Area.
Protocol No. ATX-101-07-07
Secondary ID [1] 504 0
EUDRACT ID- 2007-006303-21
Universal Trial Number (UTN)
Trial acronym
'O' study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Submental Fat 2604 0
Condition category
Condition code
Skin 2720 2720 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Eligible subjects will be randomized to 1 of 6 treatment groups (the placebo groups will be pooled for analyses):
• Placebo: up to 48 injections using a 0.7 cm grid and 0.2 mL/injection (n=4)
• Placebo: up to 24 injections using a 1.0 cm grid and 0.2 mL/injection (n=4)
• Placebo: up to 24 injections using a 1.0 cm grid and 0.4 mL/injection (n=4)
• 1.0% ATX-101: up to 48 injections using a 0.7 cm grid and 0.2 mL/injection (n=18)
• 1.0% ATX-101: up to 24 injections using a 1.0 cm grid and 0.2 mL/injection (n=12)
• 1.0% ATX-101: up to 24 injections using a 1.0 cm grid and 0.4 mL/injection (n=18)
Subjects who successfully complete screening and baseline evaluations will receive up to 48 injections (0.2 mL each, or a maximum volume of approximately 9.6 mL) or 24 injections (0.2 mL or 0.4 mL each, or a maximum volume of approximately 4.8 mL or 9.6 mL, respectively) per treatment, depending upon size and configuration of Submental Fat (SMF). Treatment will be given at four-week (± 3 days) intervals.
Intervention code [1] 2341 0
Treatment: Drugs
Comparator / control treatment
Placebo- 0.9% benzyl alcohol in sterile water for injection
Control group
Placebo

Outcomes
Primary outcome [1] 3615 0
To determine the safety and tolerability of ATX-101 injections at one concentration and three dosing paradigms, relative to placebo.
Timepoint [1] 3615 0
Subjects will undergo protocol defined tests and observations at screening, four treatment visits (Visits 2, 4, 6, and 8 [+- 3 days]), four postinjection visits each one week (+- 2 days) after treatment, safety assessments at each visit, and efficacy assessments at Visits 4, 6, 8, 10, and 12. Each subject's participation in the trial will be terminated at the conclusion of all tests and observations conducted at Visit 12 (12 weeks after the final dose of study material).
Secondary outcome [1] 6056 0
To evaluate the potential efficacy of ATX-101, relative to placebo, in reducing SMF
Timepoint [1] 6056 0
Subjects will undergo protocol defined tests and observations at screening, four treatment visits (Visits 2, 4, 6, and 8 [+- 3 days]), four postinjection visits each one week (+- 2 days) after treatment, safety assessments at each visit, and efficacy assessments at Visits 4, 6, 8, 10, and 12. Each subject's participation in the trial will be terminated at the conclusion of all tests and observations conducted at Visit 12 (12 weeks after the final dose of study material).

Eligibility
Key inclusion criteria
Inclusion Criteria
1.Submental fat that is considered undesirable by the subject and graded by the investigator as 2 or 3 using the Submental Fat (SMF) Rating Scale (Appendix C).
2.Males or nonpregnant, nonlactating females who are aged 25 to 65 years, inclusive, on the date of randomization. Females of childbearing potential must have a negative human chorionic gonadotropin (HCG) test result within 28 days before randomization and must agree to practice adequate contraception, in the judgment of the investigator, during the course of the trial.
3.History of maintenance of a stable body weight, in the judgment of the investigator, for at least 6 months before randomization.
4.The subject is expected to comply with and understand the visit schedule and all of the protocol-specified tests and procedures.
5.The subject is medically able to undergo the administration of study material as determined by clinical and laboratory evaluations (section 7) obtained within 28 days before randomization, for which the investigator identifies no clinically significant abnormality.
6.Signed informed consent obtained before any study-specific procedure is conducted..
Minimum age
25 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria
1.History of any intervention to treat submental fat (e.g., liposuction) or trauma associated with the chin or neck areas, which in the judgment of the investigator, may affect safety or efficacy evaluation of the treatment.
2.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.
3.Prominent platysmal bands at rest that interfere with the evaluation of submental fat.
4.Evidence of any cause of enlargement in the submental area (e.g., thyroid enlargement, cervical adenopathy) other than localized submental fat.
5.Fitzpatrick Skin Type IV, V, or VI (Appendix B).
6.Currently on, or considering starting, a weight reduction regimen.
7.Any medical condition (e.g., respiratory, cardiovascular, hepatic, 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.
8.Treatment with fish oil or nonsteroidal anti-inflammatory agents (NSAIDS) within seven days before randomization, or any anticipated need for agents with anticoagulative effects (e.g. warfarin, heparin) during the course of the trial. Aspirin used for prophylaxis will be allowed.
9.Treatment with oral anticoagulants (e.g., warfarin) within 28 days before randomization.
10.Treatment with radio frequency, laser procedures, chemical peel, dermal fillers in the neck or chin area within 12 months before randomization or botulinum toxin injections within 6 months before randomization.
11.History of sensitivity to any components of the study material or to topical or local anesthetics (e.g., lidocaine, benzocaine, novocaine).
12.Previous randomization into this trial.
13.Treatment with an investigational device or agent within 30 days before randomization.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Each subject will be consented to the study (via written informed consent) prior to the study-specific tests or procedures. Randomisation via a central schedule by phone/fax. Subject considered enrolled once they have undergone randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization to one of the six treatment assignments will be based on a double-blind computer generated centralized randomization schedule prepared by Kythera before the start of the study
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
This is a double-blind study so the participant and Investigator administering the treatment will be blinded as well as those assessing the outcomes. At the completion of the study unblinding will occur for the results to be abalysed and reported.
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/03/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2856 0
Commercial sector/Industry
Name [1] 2856 0
Kythera Biopharmaceuticals Inc
Country [1] 2856 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Kythera Biopharmaceuticals Inc
Address
Suite 200
27200 W. Agoura Road
Calabasas CA 91301
Country
United States of America
Secondary sponsor category [1] 2574 0
Commercial sector/Industry
Name [1] 2574 0
ICON Clinical Research
Address [1] 2574 0
Suite 201
Level 2
2-4 Lyon Park Rd
North Ryde
Sydney NSW 2113
Country [1] 2574 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 4800 0
Bellberry Limited
Ethics committee address [1] 4800 0
First Floor
71 Anzac Highway
Ashford SA 5035
Ethics committee country [1] 4800 0
Australia
Date submitted for ethics approval [1] 4800 0
27/11/2007
Approval date [1] 4800 0
Ethics approval number [1] 4800 0

Summary
Brief summary
Deoxycholate acid, or deoxycholate, is a naturally occuring bile acid produced by the liver as one of several end products of sterol metabolism. In the human body, deoxycholate serves to solubilise dietry fats and facilitate their absorption.
ATX-101 (sodium deoxycholate) is being developed by Kythera Biopharmaceuticals as a promising nonsurgical treatment modality for several conditions characterized by unwanted or excessive fat deposition including, but not limited to, lipomas, lipodystrophy in patients with HIV infection, submental and buccal fat deposits, infraorbital fat pockets, and other settings in which liposuction or surgery is the current approach. These surgeries are associated with the known risks of anaesthesia, infection, bleeding, bruising and scarring; the possibility of poor outcomes, adn the expected discomfort and 'down-time' for the patient. Given the risks, which are well-established and documented, the growing populatiry of these procedures is testament to the psychological importance of self-image and to the benefir realised by subjects who seek them. The need for an improved, legitimate and minimally invasive product for reduction of localised fat deposits is substantiated by th esignificant and growing popularity of Lipostabil@ and other unapporved extemporaneous mixtures of phosphatidylcholine/deoxycholate (PC/DC).
The objectives of this study are to 1. to determine the safety and tolerability of ATX-101 injections at one concentration and three dosing paradigms, relative to placebo, and 2. to evaluate the potential efficacy of ATX-101, relative to placebo, in reducing SMF, and thereby achieve improvement as judged by the Investigator and participant.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28228 0
Address 28228 0
Country 28228 0
Phone 28228 0
Fax 28228 0
Email 28228 0
Contact person for public queries
Name 11385 0
Justine Karpow
Address 11385 0
Suite 201
Level 2
2-4 Lyon Park Rd
North Ryde
Sydney NSW 2113
Country 11385 0
Australia
Phone 11385 0
+61 2 98593926
Fax 11385 0
+61 2 98593999
Email 11385 0
[email protected]
Contact person for scientific queries
Name 2313 0
Justine Karpow
Address 2313 0
Suite 201
Level 2
2-4 Lyon Park Rd
North Ryde
Sydney NSW 2113
Country 2313 0
Australia
Phone 2313 0
+61 2 98593926
Fax 2313 0
+61 2 98593999
Email 2313 0
[email protected]

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Results publications and other study-related documents

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