Deoxycholic Acid Injection for the Treatment of Superficial Lipomas

Phase 1, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Sequential Dose-Escalation Study of the Pharmacokinetics, Safety, and Efficacy of ATX-101 (Sodium Deoxycholate for Injection) Intralipomal Injections for the Treatment of Superficial Lipomas

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00422188

Enrollment

Registered

2007-01-15

Start date

2007-01-31

Completion date

2007-11-30

Last updated

2015-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lipoma

Brief summary

The purpose of this research is to compare the safety and effectiveness of 4 different concentrations of deoxycholic acid injection against a placebo in the treatment of superficial lipomas.

Detailed description

A lipoma is a fatty lump typically located on the trunk, shoulder, arms or legs. For the purposes of this study, only lipomas on the trunk, arms, legs, or neck were treated. (Lipomas on the face, wrists, hands, lower portion of the spine, genitals, ankles, or feet were not treated.)

Interventions

DRUGDeoxycholic Acid Injection

Administered via intralipomal injection.

DRUGPlacebo

Administered via intralipomal injection.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* One or more lipomas, based on clinical diagnosis, which are accessible for treatment and assessment, are quantifiable along at least 2 perpendicular diameters, and have the following characteristics: * History of slow growth followed by dormancy, and stable for at least 6 months. * Greatest length by greatest perpendicular width between 1 and 16 square centimeters, inclusive * Discrete, oval to rounded in shape, not hard or attached to underlying tissue * Located on the trunk, arms, legs, or neck * Stable body weight with a body mass index of less than 30 kg/m² * Signed informed consent

Exclusion criteria

* Absence of significant medical conditions that could affect safety * History of surgical treatment for lipomas * Treatment with an investigational agent within 30 days before ATX-101 treatment

Design outcomes

Primary

Measure	Time frame
Assessments of Safety with Laboratory tests	up to 16 weeks
Assessments of Safety with ECG	up to 16 weeks
Assessments of Safety with Medical Evaluations	up to 16 weeks

Secondary

Measure	Time frame
Lipoma size reduction	up to 16 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026