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NCT02123134 · ClinicalTrials.gov registry record · Phase 3

Safety Study of Deoxycholic Acid for the Reduction of Localized Subcutaneous Fat in the Submental Area in Subjects 65 to 75 Years of Age

A Phase 3 study, sponsored by Kythera Biopharmaceuticals.

Completed
Registry status
Phase 3
Development phase
55
Enrollment target

NCT02123134: Completed Phase 3 study, sponsored by Kythera Biopharmaceuticals.

NCT02123134 is a Phase 3 study that has completed, run by Kythera Biopharmaceuticals. The registered enrollment target is 55 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02123134, a Phase 3 study, has completed, sponsored by Kythera Biopharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
55 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 of participants who are 65 to 75 years old.

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 ATX-101

Trial Details

FieldValue
Enrollment Target 55 participants
Start Date 2014-04
Est. Completion 2015-09
Phase Phase 3
Kythera Biopharmaceuticals

19 total trials

What the finished NCT02123134 record still lists

NCT02123134 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT02123134 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02123134 about?

NCT02123134 is a clinical study titled "Safety Study of Deoxycholic Acid for the Reduction of Localized Subcutaneous Fat in the Submental Area in Subjects 65 to 75 Years of Age". 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 of participants who are 65 to 75 years old.

What is the current status of trial NCT02123134?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 55 participants. The study started on 2014-04. Estimated completion is 2015-09.

What interventions are being tested in trial NCT02123134?

The interventions under investigation include: Placebo (DRUG), ATX-101 (DRUG).

Who is sponsoring clinical trial NCT02123134?

This trial is sponsored by Kythera Biopharmaceuticals, which has 19 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02123134's enrollment target sits among peer trials

55 1834th of 2000 higher than 163 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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Source: ClinicalTrials.gov NCT02123134, the US trial registry maintained by the National Library of Medicine. NCT02123134 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.