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NCT01032889 · ClinicalTrials.gov registry record · Phase 2
Deoxycholic Acid Injection Submental Fat (SMF) Magnetic Resonance Imaging (MRI) and Subject-reported Outcome Measures Study
A Phase 2 study, sponsored by Kythera Biopharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 129
- Enrollment target
NCT01032889: Completed Phase 2 study, sponsored by Kythera Biopharmaceuticals.
NCT01032889 is a Phase 2 study that has completed, run by Kythera Biopharmaceuticals. The registered enrollment target is 129 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01032889, a Phase 2 study, has completed, sponsored by Kythera Biopharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 129 participants
- Enrollment target
Study Summary
Evaluation of the safety, tolerability and efficacy of deoxycholic acid injection in the reduction of submental fat (fat below the chin).
Primary Outcome
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. A negative change from Baseline indicates improvement.
Interventions
- DRUG Placebo
- DRUG Deoxycholic acid injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 129 participants |
| Start Date | 2009-12 |
| Est. Completion | 2010-12 |
| Phase | Phase 2 |
What the finished NCT01032889 record still lists
NCT01032889 is an interventional study that assigns participants to a tested intervention. The registered 129 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01032889 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01032889 about?
NCT01032889 is a clinical study titled "Deoxycholic Acid Injection Submental Fat (SMF) Magnetic Resonance Imaging (MRI) and Subject-reported Outcome Measures Study". Evaluation of the safety, tolerability and efficacy of deoxycholic acid injection in the reduction of submental fat (fat below the chin).
What is the current status of trial NCT01032889?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 129 participants. The study started on 2009-12. Estimated completion is 2010-12.
What interventions are being tested in trial NCT01032889?
The interventions under investigation include: Placebo (DRUG), Deoxycholic acid injection (DRUG).
Who is sponsoring clinical trial NCT01032889?
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 NCT01032889's enrollment target sits among peer trials
129 553rd of 2000 higher than 1,448 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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