CLINICAL TRIALS PROFILE FOR KYBELLA

All Clinical Trials for KYBELLA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01032889 ↗	Deoxycholic Acid Injection Submental Fat (SMF) Magnetic Resonance Imaging (MRI) and Subject-reported Outcome Measures Study	Completed	Kythera Biopharmaceuticals	Phase 2	2009-12-01	Evaluation of the safety, tolerability and efficacy of deoxycholic acid injection in the reduction of submental fat (fat below the chin).
NCT01426373 ↗	Open-Label Study of Deoxycholic Acid for the Reduction of Localized Subcutaneous Fat in the Submental Area	Completed	Kythera Biopharmaceuticals	Phase 3	2011-08-01	To evaluate the safety of deoxycholic acid subcutaneous injections in the submental area (below the chin).
NCT01542034 ↗	Phase 3 Study of Deoxycholic Acid Injection (ATX-101) Versus Placebo for the Reduction of Localized Subcutaneous Fat in the Submental Area	Completed	Kythera Biopharmaceuticals	Phase 3	2012-02-01	To evaluate the safety and efficacy of deoxycholic acid injection in the reduction of submental fat (fat below the chin).
NCT01546142 ↗	Phase 3 Study of Deoxycholic Acid Injection (ATX-101) Versus Placebo for the Reduction of Localized Subcutaneous Fat in the Submental Area	Completed	Kythera Biopharmaceuticals	Phase 3	2012-03-01	To evaluate the safety and efficacy of deoxycholic acid injection in the reduction of submental fat (fat below the chin).
NCT02007434 ↗	Patient Experience Study of Deoxycholic Acid Injection	Completed	Kythera Biopharmaceuticals	Phase 3	2013-12-01	The objectives of this study are to determine the safety of deoxycholic acid subcutaneous (SC) injections in the submental area and to evaluate the effects of four interventions, relative to placebo in the submental area, particularly with regard to assessment and management of pain, bruising, and swelling/edema.
NCT03241563 ↗	Subcutaneous Sodium Deoxycholate Injections With or Without Triamcinolone for Reduction of Submental Fat	Completed	Allergan	Phase 4	2016-04-01	The subjects and evaluating investigator will be blinded to the treatment, thus maintaining double-blind status. By nature of the varying volumes of injection, the treating investigator will be unblinded to the treatment. A series of 3 injection sessions will be performed spaced 4 weeks apart. Canfield Vectra 3D imaging will be performed at baseline and at each follow up visit. Follow up visits will be performed 3 and 5 days after each injection session to assess for side effect and tolerability profile. After the final injection session, additional follow up visits will be performed at days 90 and 180 to assess for efficacy. Subject weight will be recorded at baseline and at end of study.
NCT03241563 ↗	Subcutaneous Sodium Deoxycholate Injections With or Without Triamcinolone for Reduction of Submental Fat	Completed	Goldman, Butterwick, Fitzpatrick and Groff	Phase 4	2016-04-01	The subjects and evaluating investigator will be blinded to the treatment, thus maintaining double-blind status. By nature of the varying volumes of injection, the treating investigator will be unblinded to the treatment. A series of 3 injection sessions will be performed spaced 4 weeks apart. Canfield Vectra 3D imaging will be performed at baseline and at each follow up visit. Follow up visits will be performed 3 and 5 days after each injection session to assess for side effect and tolerability profile. After the final injection session, additional follow up visits will be performed at days 90 and 180 to assess for efficacy. Subject weight will be recorded at baseline and at end of study.

Clinical Trial Conditions for KYBELLA

Condition Name

Condition Name for KYBELLA
Intervention	Trials
Moderate or Severe Submental Fullness	5
Adiposity	3
Neurofibromatosis 1	2
Upper Back Fat	1

Condition MeSH

Condition MeSH for KYBELLA
Intervention	Trials
Neurofibromatosis 1	3
Neurofibromatoses	3
Neurofibroma	3
Obesity	3

Clinical Trial Locations for KYBELLA

Trials by Country

Trials by Country for KYBELLA
Location	Trials
United States	66
Canada	6

Trials by US State

Trials by US State for KYBELLA
Location	Trials
California	8
Illinois	5
New York	4
Florida	4
Maryland	3

Clinical Trial Progress for KYBELLA

Clinical Trial Phase

Clinical Trial Phase for KYBELLA
Clinical Trial Phase	Trials
Phase 4	5
Phase 3	4
Phase 2	1

Clinical Trial Status

Clinical Trial Status for KYBELLA
Clinical Trial Phase	Trials
Completed	10
Recruiting	3
Not yet recruiting	1

Clinical Trial Sponsors for KYBELLA

Sponsor Name

Sponsor Name for KYBELLA
Sponsor	Trials
Kythera Biopharmaceuticals	5
Johns Hopkins University	3
Massachusetts General Hospital	3

Sponsor Type

Sponsor Type for KYBELLA
Sponsor	Trials
Other	13
Industry	9