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Generated: December 11, 2018

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CLINICAL TRIALS PROFILE FOR KYBELLA

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Clinical Trials for Kybella

Trial ID Title Status Sponsor Phase Summary
NCT01032889 Deoxycholic Acid Injection Submental Fat (SMF) Magnetic Resonance Imaging (MRI) and Subject-reported Outcome Measures Study Completed Kythera Biopharmaceuticals Phase 2 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 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 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 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 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 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 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.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Kybella

Condition Name

Condition Name for Kybella
Intervention Trials
Moderate or Severe Submental Fullness 5
Fat Reduction 1
Body Fat Disorder 1
Adiposity 1
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Condition MeSH

Condition MeSH for Kybella
Intervention Trials
Lipid Metabolism Disorders 1
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Clinical Trial Locations for Kybella

Trials by Country

Trials by Country for Kybella
Location Trials
United States 61
Canada 6
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Trials by US State

Trials by US State for Kybella
Location Trials
California 7
Illinois 5
Texas 3
Minnesota 3
Maryland 3
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Clinical Trial Progress for Kybella

Clinical Trial Phase

Clinical Trial Phase for Kybella
Clinical Trial Phase Trials
Phase 4 3
Phase 3 4
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Kybella
Clinical Trial Phase Trials
Completed 6
Recruiting 2
Active, not recruiting 1
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Clinical Trial Sponsors for Kybella

Sponsor Name

Sponsor Name for Kybella
Sponsor Trials
Kythera Biopharmaceuticals 5
Allergan 2
Goldman, Butterwick, Fitzpatrick and Groff 2
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Sponsor Type

Sponsor Type for Kybella
Sponsor Trials
Industry 8
Other 4
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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
US Army
Colorcon
Citi
Daiichi Sankyo
Chubb
Boehringer Ingelheim
AstraZeneca
Deloitte

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