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NCT02035267 · ClinicalTrials.gov registry record · Phase 3
Safety Study of ATX-101 (Deoxycholic Acid) in Subjects With Mild or Extreme Fullness of Submental Fat
A Phase 3 study, sponsored by Kythera Biopharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 93
- Enrollment target
NCT02035267: Completed Phase 3 study, sponsored by Kythera Biopharmaceuticals.
NCT02035267 is a Phase 3 study that has completed, run by Kythera Biopharmaceuticals. The registered enrollment target is 93 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02035267, a Phase 3 study, has completed, sponsored by Kythera Biopharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 93 participants
- Enrollment target
Study Summary
The objectives of this study are to explore the safety and efficacy of subcutaneous injections of Deoxycholic Acid relative to placebo, in the submental area in patients with mild or extreme fullness of the submental fat and ratings of 1 or 4.
Primary Outcome
The investigator evaluated the participant's chin and neck area using the Clinician-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst). The participant evaluated their chin and neck area using the Patient-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst).
Interventions
- DRUG Placebo
- DRUG Deoxycholic Acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 93 participants |
| Start Date | 2014-01 |
| Est. Completion | 2015-06 |
| Phase | Phase 3 |
What the finished NCT02035267 record still lists
NCT02035267 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 93 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02035267 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02035267 about?
NCT02035267 is a clinical study titled "Safety Study of ATX-101 (Deoxycholic Acid) in Subjects With Mild or Extreme Fullness of Submental Fat". The objectives of this study are to explore the safety and efficacy of subcutaneous injections of Deoxycholic Acid relative to placebo, in the submental area in patients with mild or extreme fullness of the submental fat and ratings of 1 or 4.
What is the current status of trial NCT02035267?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 93 participants. The study started on 2014-01. Estimated completion is 2015-06.
What interventions are being tested in trial NCT02035267?
The interventions under investigation include: Placebo (DRUG), Deoxycholic Acid (DRUG).
Who is sponsoring clinical trial NCT02035267?
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 NCT02035267's enrollment target sits among peer trials
93 1722nd of 2000 higher than 278 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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