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ATX-101 Abdominoplasty

Phase 1, Open-label Study of the Safety, Tolerability, and Histological Effect of Single Doses of ATX-101 (Sodium Deoxycholate for Injection) Administered in Abdominal Fat in Subjects Undergoing Abdominoplasty

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00835952
Acronym
ATX-101-08-10
Enrollment
14
Registered
2009-02-04
Start date
2008-11-30
Completion date
2009-04-30
Last updated
2010-01-27

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

Conditions

Characteristics of Subcutaneous Fat

Brief summary

Histopathological study of abdominal fat excised from subjects undergoing abdominoplasty

Interventions

ATX-101 single doses

Sponsors

Kythera Biopharmaceuticals
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy subjects undergoing planned abdominoplasty

Exclusion criteria

* History of interventions in the abdominal area

Design outcomes

Primary

MeasureTime frame
Adverse events, laboratory test results, physical examinations1 - 28 days

Secondary

MeasureTime frame
Histopathology1 - 28 Days

Countries

United States

Outcome results

None listed

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