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Efficacy of a Novel Injection Lipolysis to Induce Targeted Adipocyte Apoptosis: A Randomized, Phase IIa Study of CBL-514 Injection on Abdominal Subcutaneous Fat Reduction.
Goodman, Greg J; Ho, Wilson W S; Chang, Kao-Jung; Ling, Yu-Fang; Sheu, An-Yi.
  • Goodman GJ; Monash University, Melbourne, Victoria, Australia.
  • Ling YF; Caliway Biopharmaceuticals Co., Ltd., New Taipei City, Taiwan.
  • Sheu AY; Caliway Biopharmaceuticals Co., Ltd., New Taipei City, Taiwan.
Aesthet Surg J ; 42(11): NP662-NP674, 2022 Oct 13.
Article in English | MEDLINE | ID: covidwho-1901113
ABSTRACT

BACKGROUND:

CBL-514 is a novel injectable drug that may be safe and efficacious for localized abdominal subcutaneous fat reduction.

OBJECTIVES:

The aim of this study was to assess the safety and efficacy of CBL-514 in reducing abdominal subcutaneous fat volume and thickness.

METHODS:

This Phase IIa, open-label, random allocation study consisted of a 6-week treatment period and follow-up at 4 and 8 weeks following the last treatment. Participants were randomly allocated to receive 1.2 mg/cm2 (180 mg), 1.6 mg/cm2 (240 mg), or 2.0 mg/cm2 (300 mg) of CBL-514 with up to 4 treatments, each comprising 60 injections into the abdominal adipose layer. Changes in abdominal subcutaneous fat were assessed by ultrasound at follow-up visits. Treatment-emergent adverse events were recorded.

RESULTS:

Higher doses of CBL-514 (unit dose, 2.0 and 1.6 mg/cm2) significantly improved the absolute and percentage reduction in abdominal fat volume (P < 0.00001) and thickness (P < 0.0001) compared with baseline. Although the COVID-19 pandemic halted some participant recruitment and follow-ups, analysis was unaffected, even after sample size limitations.

CONCLUSIONS:

CBL-514 injection at multiple doses up to 300 mg with a unit dose of 2.0 mg/cm2 is safe, well-tolerated, and reduced abdominal fat volume and thickness by inducing adipocyte apoptosis. Although other procedures exist to treat abdominal fat, they have limitations and may cause complications. At a dose of 2.0 mg/cm2, CBL-514 safely and significantly reduced abdominal fat volume by 24.96%, making it a promising new treatment for routine, nonsurgical abdominal fat reduction in dermatologic clinics.
Subject(s)

Full text: Available Collection: International databases Database: MEDLINE Main subject: Subcutaneous Fat, Abdominal / COVID-19 Type of study: Cohort study / Experimental Studies / Prognostic study / Randomized controlled trials Limits: Humans Language: English Journal: Aesthet Surg J Year: 2022 Document Type: Article Affiliation country: Asj

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Subcutaneous Fat, Abdominal / COVID-19 Type of study: Cohort study / Experimental Studies / Prognostic study / Randomized controlled trials Limits: Humans Language: English Journal: Aesthet Surg J Year: 2022 Document Type: Article Affiliation country: Asj