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NCT01542034 · ClinicalTrials.gov registry record · Phase 3
Phase 3 Study of Deoxycholic Acid Injection (ATX-101) Versus Placebo for the Reduction of Localized Subcutaneous Fat in the Submental Area
A Phase 3 study, sponsored by Kythera Biopharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 506
- Enrollment target
NCT01542034: Completed Phase 3 study, sponsored by Kythera Biopharmaceuticals.
NCT01542034 is a Phase 3 study that has completed, run by Kythera Biopharmaceuticals. The registered enrollment target is 506 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (34% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01542034, a Phase 3 study, has completed, sponsored by Kythera Biopharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 506 participants
- Enrollment target
Study Summary
To evaluate the safety and efficacy of deoxycholic acid injection in the reduction of submental fat (fat below the chin).
Primary Outcome
A composite 1-grade response is defined as at least a 1-grade improvement from Baseline on both the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) 12 weeks after the last treatment. The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme. The PR-SMFRS is bas
Interventions
- DRUG Placebo
- DRUG Deoxycholic acid injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 506 participants |
| Start Date | 2012-02 |
| Est. Completion | 2013-08 |
| Phase | Phase 3 |
What the finished NCT01542034 record still lists
NCT01542034 is an interventional study that assigns participants to a tested intervention. The registered 506 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (34% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01542034 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01542034 about?
NCT01542034 is a clinical study titled "Phase 3 Study of Deoxycholic Acid Injection (ATX-101) Versus Placebo for the Reduction of Localized Subcutaneous Fat in the Submental Area". To evaluate the safety and efficacy of deoxycholic acid injection in the reduction of submental fat (fat below the chin).
What is the current status of trial NCT01542034?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 506 participants. The study started on 2012-02. Estimated completion is 2013-08.
What interventions are being tested in trial NCT01542034?
The interventions under investigation include: Placebo (DRUG), Deoxycholic acid injection (DRUG).
Who is sponsoring clinical trial NCT01542034?
This trial is sponsored by Kythera Biopharmaceuticals, which has 19 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01542034's enrollment target sits among peer trials
506 741st of 2000 higher than 1,259 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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