Long Term Follow-up Study on Safety and Maintenance of Efficacy of ATX-101

Kythera Biopharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Healthy; Submental Fat

Treatments: Drug: Placebo; Drug: ATX-101 (2 mg/cm^2); Drug: ATX-101 (4 mg/cm^2); Drug: ATX-101 (1 mg/cm^2)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02159729

ATX-101-08-12

Details and patient eligibility

About

This was a long-term follow-up study of participants who completed Kythera-sponsored trials of ATX-101 (06-03, 07-07, 09-15)

Full description

No study medication was administered in this study.

Enrollment: 205 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Any subject who successfully completed a Kythera-sponsored clinical trial of ATX-101 (06-03, 07-07, 09-15)
• Signed informed consent
• Willingness to comply with schedule and procedures of the study

Exclusion criteria

• Subjects who have had or are undergoing treatment that may affect the evaluation of the submental area will be excluded

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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205 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants treated with placebo in previous ATX-101 studies

Treatment:

Drug: Placebo

ATX-101 (1 mg/cm^2)

Experimental group

Description:

Participants treated with ATX-101 (1 mg/cm\^2) in previous phase 2 studies

Treatment:

Drug: ATX-101 (1 mg/cm^2)

ATX-101 (2 mg/cm^2)

Experimental group

Description:

Participants treated with ATX-101 (2 mg/cm\^2) in previous phase 2 studies

Treatment:

Drug: ATX-101 (2 mg/cm^2)

ATX-101 (4 mg/cm^2)

Experimental group

Description:

Participants treated with ATX-101 (4 mg/cm\^2) in previous phase 2 studies

Treatment:

Drug: ATX-101 (4 mg/cm^2)