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NCT01426373 · ClinicalTrials.gov registry record · Phase 3

Open-Label Study of Deoxycholic Acid 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
165
Enrollment target

NCT01426373: Completed Phase 3 study, sponsored by Kythera Biopharmaceuticals.

NCT01426373 is a Phase 3 study that has completed, run by Kythera Biopharmaceuticals. The registered enrollment target is 165 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01426373, a Phase 3 study, has completed, sponsored by Kythera Biopharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
165 participants
Enrollment target

Study Summary

To evaluate the safety of deoxycholic acid subcutaneous injections in the submental area (below the chin).

Primary Outcome

Serious AEs include any event that met one or more of the following criteria: was fatal or life-threatening, required inpatient hospitalization or prolonged a hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or a significant medical hazard. The severity of each AE was defined as either: Mild: The participant was aware of the sign or symptom, but it was easily tolerated. Moderate: The sign or symptom caused discomfort and inter

Interventions

  • DRUG Deoxycholic acid injection

Trial Details

FieldValue
Enrollment Target 165 participants
Start Date 2011-08
Est. Completion 2013-06
Phase Phase 3
Kythera Biopharmaceuticals

19 total trials

What the finished NCT01426373 record still lists

NCT01426373 is an interventional study that assigns participants to a tested intervention. The registered 165 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 (79% lower).

The record links to 0 conditions, and to 1 intervention - of which Deoxycholic acid injection is the first listed.

NCT01426373 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01426373 about?

NCT01426373 is a clinical study titled "Open-Label Study of Deoxycholic Acid for the Reduction of Localized Subcutaneous Fat in the Submental Area". To evaluate the safety of deoxycholic acid subcutaneous injections in the submental area (below the chin).

What is the current status of trial NCT01426373?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 165 participants. The study started on 2011-08. Estimated completion is 2013-06.

What interventions are being tested in trial NCT01426373?

The interventions under investigation include: Deoxycholic acid injection (DRUG).

Who is sponsoring clinical trial NCT01426373?

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 NCT01426373's enrollment target sits among peer trials

165 1465th of 2000 higher than 531 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 NCT01426373, the US trial registry maintained by the National Library of Medicine. NCT01426373 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.