Evaluation of Safety and Efficacy of ATX-101 in the Reduction of Submental Fat

This study has been completed.
Sponsor:
Collaborator:
Bayer
Information provided by:
Kythera Biopharmaceuticals
ClinicalTrials.gov Identifier:
NCT01305577
First received: February 10, 2011
Last updated: October 11, 2012
Last verified: October 2012
  Purpose

Kythera is evaluating the safety and efficacy of ATX-101 in the reduction of submental fat. ATX-101 is a potential treatment that is a safe and effective nonsurgical approach to reduce localized subcutaneous fat in the submental area in otherwise healthy individuals.


Condition Intervention Phase
Healthy
Drug: ATX-101
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of ATX-101 (Sodium Deoxycholate Injection) Versus Placebo for the Reduction of Localized Subcutaneous Fat in the Submental Area

Resource links provided by NLM:


Further study details as provided by Kythera Biopharmaceuticals:

Primary Outcome Measures:
  • Submental Fat Rating Scale [ Time Frame: 12 weeks after last treatment ] [ Designated as safety issue: No ]
    Submental Fat Rating Scale - A clinician's assessment of the amount of submental fat and a Subject Self Rating Scale


Secondary Outcome Measures:
  • Subject Reported Outcome Measures [ Time Frame: 12 weeks after last treatment ] [ Designated as safety issue: No ]
    Subject-Reported Outcome Measures will include: PR-SMFRS, PR-SMFIS and Self-Ratings of Attractiveness.


Estimated Enrollment: 360
Study Start Date: December 2010
Study Completion Date: April 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo vehicle control
Drug: Placebo
Placebo: Subjects will receive one of two dosing regimens of ATX-101 (1 mg/cm2 or 2 mg/cm2) or placebo, administered monthly for up to 3 months into the submental area.
Other Name: Placebo vehicle
Experimental: ATX-101 1mg/cm2
ATX-101 1mg/cm2
Drug: ATX-101
ATX-101 1mg/cm2 - Subjects will receive one of two dosing regimens of ATX-101 (1 mg/cm2 or 2 mg/cm2) or placebo, administered monthly for up to 3 months into the submental area.
Other Name: sodium deoxycholate injection
Experimental: ATX-101 2 mg/cm2
ATX-101 2 mg/cm2
Drug: ATX-101
ATX-101 2mg/cm2 - Subjects will receive one of two dosing regimens of ATX-101 (1 mg/cm2 or 2 mg/cm2) or placebo, administered monthly for up to 3 months into the submental area.
Other Name: sodium deoxycholate injection

Detailed Description:

Phase 3, multicenter, randomized, double-blind, placebo-controlled study of ATX-101 (sodium deoxycholate injection) versus placebo for the reduction of localized subcutaneous fat in the submental area

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Submental fat graded by the investigator as 2 or 3 using the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) as determined on Visit 2.
  2. Dissatisfaction with the submental area rated by the subject as 0, 1, 2, or 3 using the Subject Self Rating Scale (SSRS).
  3. Males and nonpregnant, nonlactating females between 18 and 65 years of age, inclusive on the day of randomization. Females of childbearing potential must have a negative human chorionic gonadotropin (hCG) test result within 28 days before randomization and agree to practice medically acceptable birth control during the course of the study. Medically acceptable birth control includes: surgical sterilization, hormonal contraceptives, barrier methods or an intrauterine device (IUD).
  4. History of stable body weight, in the judgment of the investigator, for at least 6 months before randomization. No significant change, in the judgment of the investigator, in diet or exercise practices for at least 6 months before randomization and agreement to not change diet or exercise practices during the course of the study.
  5. Expected to comply with and understand the visit schedule and all protocol-specified tests and procedures.
  6. Medically able to undergo the administration of study material determined by clinical evaluations made within 56 days before and laboratory tests obtained within 28 days before randomization for which the investigator identified no clinically significant abnormality.
  7. Signed informed consent obtained before any study-specific procedure is performed.

Exclusion Criteria:

  1. History of any intervention to treat submental fat (e.g., liposuction, surgery, or lipolytic agents) or trauma associated with the chin or neck areas, which in the judgment of the investigator may affect evaluation of safety or efficacy of 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 an aesthetically unacceptable outcome or a score of 4 on the Skin Laxity Rating Scale (SLRS, Appendix C2).
  3. Prominent platysmal bands at rest or other anatomical features that, in the judgment of the investigator, may interfere with the evaluation of submental fat or result in an aesthetically unacceptable outcome.
  4. Evidence of any cause of enlargement in the submental area (e.g., thyroid enlargement or cervical adenopathy) other than localized submental fat.
  5. Body mass index (BMI) greater than 30 (Appendix B1).
  6. Currently on or considering starting a weight reduction regimen.
  7. Any medical condition (e.g., respiratory, cardiovascular, hepatic, neurological disease, uncontrolled hypertension, or thyroid dysfunction) that would interfere with assessment of safety or efficacy or compromise the subject's ability to undergo study procedures or provide informed consent.
  8. Treatment with radio frequency, laser procedures, chemical peels, or dermal fillers in the neck or chin area within 12 months before randomization, or botulinum toxin injections in the neck or chin area within 6 months before randomization.
  9. History of sensitivity to any components of the study material or to topical or local anesthetics (e.g., lidocaine, benzocaine, or novocaine).
  10. Previous randomization into this study or previous treatment with ATX-101.
  11. Treatment with an investigational device or agent within 30 days of randomization.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01305577

Locations
Belgium
Joan Vandeputte
Oudenaarde, Oost vlaanderen, Belgium, 9700
France
Hugues Cartier
Arras, France, 62000
Isaac Bodokh
Cannes, France, 06400
Jean-Paul Ortonne
Nice, France, 06202 cedex 3
Elie Cattan
Pantin, France, 93500
Bruno Halioua
Paris, France, 75005
Daniel Interligator
Paris, France, 75010
Germany
Ridwan Weber
Augsburg, Germany, 86163
Georg Popp
Augsburg, Germany, 86179
Berthold Rzany
Berlin, Germany, 10117
Gerhard Sattler
Darmstadt, Germany, 64297
Maurizio Podda
Darmstadt, Germany, 64297
Diamant Thaci
Frankfurt/Main, Germany, 60596
Klaus Fritz
Landau, Germany, 76829
Torsten Walker
Ludwigshafen, Germany, 67061
Tatjana Pavicic
München, Germany, 80337
Andrea Graefe
Northeim, Germany, D-37154
Tanja Fischer
Potsdam, Germany, 14469
Marc Heckmann
Starnberg, Germany, 82319
Thomas Dirschka
Wuppertal, Germany, 42275
Italy
Norma ssa Cameli
Roma, Italy, 00144
Spain
Gerardo Moreno Arias
Barcelona, Spain, 08022
Jesús Benito Ruiz
Barcelona, Spain, 08017
Jaume Masia Ayala
Barcelona, Spain, 08034
Josep González Castro
Barcelona, Spain, 08028
United Kingdom
Salford Royal NHS Foundation Trust
Salford, Manchester, United Kingdom, M6 8HD
Elisabeth Dancey
London, United Kingdom, SW1 9QN
John Tanqueray
Northampton, United Kingdom, NN4 7BU
Shahida Ullah
Nottingham, United Kingdom, NG9 8AR
Ross Martin
Nottingham, United Kingdom, NG3 7DQ
James McDiarmid
Plymouth, United Kingdom, PL6 8BX
Stephen Bassett
Swansea, United Kingdom, SA2 0GU
Sponsors and Collaborators
Kythera Biopharmaceuticals
Bayer
Investigators
Study Director: Patricia Walker, MD, PhD Kythera Biopharmaceuticals
  More Information

No publications provided

Responsible Party: Daniel R. Lee, M.S., Director, Clinical Affairs, Kythera Biopharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01305577     History of Changes
Other Study ID Numbers: ATX-101-10-16, 2010-020690-17
Study First Received: February 10, 2011
Last Updated: October 11, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Kythera Biopharmaceuticals:
Healthy Subjects

Additional relevant MeSH terms:
Deoxycholic Acid
Cholagogues and Choleretics
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014