Open-Label Study of Deoxycholic Acid for the Reduction of Localized Subcutaneous Fat in the Submental Area

Recruiting at17 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Kythera Biopharmaceuticals

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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

Research Team

Frederick Beddingfield, III, M.D., PhD

Principal Investigator

Kythera Biopharmaceuticals, Inc

Eligibility Criteria

Inclusion Criteria

Submental fat graded by the investigator as 2, 3, or 4 using the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and graded by the subject as 2, 3, or 4 using the Patient-Reported Submental Fat Rating Scale (PR-SMFRS) as determined on visit 1 (within 28 days before the subject's first dosing session)

Dissatisfaction with the submental area rated by the subject as 0, 1, or 2 using the Subject Self-rating Scale (SSRS) as determined on visit 1 (within 28 days before the subject's first dosing session)

Males and nonpregnant, nonlactating females 18 years of age or greater, on the day of the subject's first dosing session (visit 2). Females of childbearing potential must have a negative human chorionic gonadotropin (serum) test result within 28 days before visit 2 and agree to practice adequate contraception, in the judgment of the investigator, during the course of the study

Treatment Details

Interventions

• Deoxycholic Acid Injection (Other)

Participant Groups

Group I: Deoxycholic Acid 2 mg/cm² Experimental Treatment 1 Intervention

Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.

Who Is Running the Clinical Trial?

Kythera Biopharmaceuticals

Lead Sponsor

Trials

23

Recruited

4,300+