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

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

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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