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Long-term, follow-up study of subjects who completed phase III trials ATX-101-10-16 or ATX-101-10-17 (sodium deoxycholate injection) for the reduction of localized subcutaneous fat in the submental area - Long-term follow-up study of ATX-101 for reduction of localized submental fat

Long-term, follow-up study of subjects who completed phase III trials ATX-101-10-16 or ATX-101-10-17 (sodium deoxycholate injection) for the reduction of localized subcutaneous fat in the submental area - Long-term follow-up study of ATX-101 for reduction of localized submental fat

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2011-005026-21-DE
Enrollment
200
Registered
2011-11-07
Start date
2012-01-31
Completion date
Unknown
Last updated
2022-04-04

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

Conditions

Reduction of subcutaneous fat in the submental area MedDRA version: 17.1 Level: PT Classification code 10016251 Term: Fat tissue increased System Organ Class: 10018065 - General disorders and administration site conditions

Interventions

Product Name: ATX-101 Product Code: ATX-101 Pharmaceutical Form: Solution for injection CAS Number: 302-95-4 Current Sponsor code: ATX-101 Other descriptive name: SODIUM DEOXYCHOLATE Concentration uni

Sponsors

KYTHERA Biopharmaceuticals, Inc.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Signed written informed consent before any study-related activities are carried out - Any subject who successfully completed the final visit (Visit 7) of a phase III clinical trial, ATX-101-16 or ATX-101-17 for the reduction of submental fat, i.e. subjects must have at least one study treatment administered and have completed the predecessor study up to Visit 7 - Willingness to comply with the schedule and procedures of the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Subjects who, since the completion of the prior phase III study ATX-101-10-16 or ATX-101-10-17, have had or who are undergoing treatment that may affect the evaluation of the submental area (e.g. - but not limited to - long term treatment with systemic corticosteroids, liposuction, surgery or other lipolytic treatment in the submental area, treatment with radio frequency, laser procedures, chemical peels, dermal fillers in the neck or chin area or botulinum toxin injections in the neck or chin area).

Design outcomes

Primary

MeasureTime frame
Main Objective: To evaluate the long-term efficacy and safety of transcutaneous injections of ATX-101 in the submental area;Secondary Objective: ;Primary end point(s): To evaluate the long-term efficacy and safety of transcutaneous injections of ATX-101 in the submental area; primary variable is not applicable—

Countries

Germany

Contacts

Public ContactHead Clinical Trial Reg Service

PAREXEL International

ctrs.eudract@parexel.com+4930306850

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026