Phase 1-2 Study of Deoxycholic Acid Injection (ATX-101) for the Reduction of Submental Fat

Kythera Biopharmaceuticals

Status and phase: Completed; Phase 2; Phase 1

Conditions: Moderate or Severe Submental Fullness

Treatments: Drug: Deoxycholic Acid Injection; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00618722

2007-000146-13 (EudraCT Number)

ATX-101-06-03

Details and patient eligibility

About

To evaluate the safety and potential efficacy of deoxycholic acid injection compared to placebo for the reduction of submental fat (fat below the chin).

Full description

The trial included an initial cohort (3 participants in each arm) to evaluate safety followed by expansion to a second, larger cohort if adequate safety was determined in the initial cohort. Data from both cohorts was pooled for analysis.

Enrollment: 85 patients

Sex: All

Ages: 25 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Submental fat (SMF) that was considered undesirable by the subject and graded by the investigator as 2 or 3 using the SMF rating scale
• Good general health
• Signed informed consent

Exclusion criteria

• History of any treatment in the neck or chin area
• Loose skin or prominent platysmal bands in the neck or chin area
• Recent treatment with anticoagulants
• Presence of clinically significant health problems

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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85 participants in 4 patient groups, including a placebo group

Deoxycholic Acid Injection 1 mg/cm²

Experimental group

Description:

Participants received 0.5% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (1 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.

Treatment:

Drug: Deoxycholic Acid Injection

Deoxycholic acid Injection 2 mg/cm²

Experimental group

Description:

Participants received 1.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (2 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.

Treatment:

Drug: Deoxycholic Acid Injection

Deoxycholic acid Injection 4 mg/cm²

Experimental group

Description:

Participants received 2.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (4 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.

Treatment:

Drug: Deoxycholic Acid Injection

Placebo

Placebo Comparator group

Description:

Participants received placebo administered in 0.2 mL injections, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.

Treatment:

Drug: Placebo