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Safety Study of ATX-101 (Deoxycholic Acid) in Subjects With Mild or Extreme Fullness of Submental Fat

K

Kythera Biopharmaceuticals

Status and phase

Completed
Phase 3

Conditions

Efficacy
Moderate to Severe Convexity of Submental Fat
Safety

Treatments

Drug: Placebo
Drug: Deoxycholic Acid

Study type

Interventional

Funder types

Industry

Identifiers

NCT02035267
ATX-101-13-27

Details and patient eligibility

About

The objectives of this study are to explore the safety and efficacy of subcutaneous injections of Deoxycholic Acid relative to placebo, in the submental area in patients with mild or extreme fullness of the submental fat and ratings of 1 or 4.

Enrollment

93 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Male and female subjects, 18 to 65 years old
  • Stable Body weight
  • Body Mass Index (BMI) of ≤40.0 kg/m^2
  • Acceptable volume of submental fat graded by clinician
  • Dissatisfaction with the submental area expressed by the subject
  • Signed informed consent form (ICF)
  • SMF ratings of 1 or 4

Exclusion criteria

  • No prior intervention for submental fat (SMF) (eg, liposuction, surgery, or lipolytic agents)
  • Presence of clinically significant health problems
  • History of trauma associated with the chin or neck areas that in the judgment of the investigator may affect evaluation of safety or efficacy of treatment
  • Body mass index ≤40 kg/m^2

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

93 participants in 4 patient groups, including a placebo group

Placebo - Grade 1
Placebo Comparator group
Description:
Participants received placebo administered in 0.2 mL subcutaneous (SC) injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments. Participants With CR SMFRS Grade 1 (mild).
Treatment:
Drug: Placebo
ATX-101 deoxycholic acid injection - Grade 1
Experimental group
Description:
Participants received deoxycholic acid 2 mg/cm\^2 administered in 0.2 mL SC injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments. Participants With Clinician-Reported Submental Fat Rating Scale (CR SMFRS) Grade 1 (mild).
Treatment:
Drug: Deoxycholic Acid
Placebo - Grade 4
Placebo Comparator group
Description:
Participants received placebo administered in 0.2 mL SC injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments. Participants With CR SMFRS Grade 4 (extreme).
Treatment:
Drug: Placebo
ATX-101 deoxycholic acid injection - Grade 4
Experimental group
Description:
Participants received deoxycholic acid 2 mg/cm\^2 administered in 0.2 mL SC injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments. Participants with CR SMFRS Grade 4 (extreme).
Treatment:
Drug: Deoxycholic Acid

Trial contacts and locations

8

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Data sourced from clinicaltrials.gov

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