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

Kythera Biopharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Healthy; Submental Fat

Treatments: Drug: ATX-101; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02163902

ATX-101-13-35

Details and patient eligibility

About

The investigation of the long-term safety and maintenance of efficacy of ATX-101 in reduction of submental fat.

Full description

No study medication is administered in this study.

Enrollment: 224 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Any participant who completed follow-up visits at 12 and 24 weeks after the last dose in one of the two predecessor studies
2. Willingness to comply with the schedule and procedures of this study.
3. Signed informed consent form (ICF).

Exclusion criteria

1. Participants who have had any treatment or condition (e.g., pregnancy or metabolic disease, which may lead to unstable weight) that may affect assessment of safety or efficacy since enrollment in the predecessor study.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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224 participants in 2 patient groups, including a placebo group

ATX-101

Experimental group

Description:

Participants treated with ATX-101 in previous studies ATX-101-11-22 and ATX-101-11-23.

Treatment:

Drug: ATX-101

Placebo

Placebo Comparator group

Description:

Participants treated with placebo in previous studies ATX-101-11-22 and ATX-101-11-23.

Treatment:

Drug: Placebo