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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05736107
Other study ID # CBL-0204
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date May 30, 2023
Est. completion date June 2024

Study information

Verified date February 2024
Source Caliway Biopharmaceuticals Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a randomized, placebo-controlled, Phase 2b study to evaluate the efficacy, safety, and tolerability of CBL-514 injection for reducing subcutaneous fat.


Description:

A total of approximately 110 adult participants with moderate or severe abdominal fat as assessed by the Investigator via live evaluation using the Clinician-Reported Abdominal Fat Rating Scale (CR-AFRS) at Screening will be enrolled. Each participant will receive up to 4 treatments of allocated CBL-514 (2 mg/cm²) or placebo administered subcutaneously to the abdomen, once every 3 weeks.


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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
CBL-514 Injection
Formulated as an injectable CBL-514 solution at a concentration of 5 mg/mL.
Other:
0.9% Sodium Chloride
Sodium Chloride (0.9% NaCl) placebo for injection

Locations

Country Name City State
United States Investigational site 1 Pflugerville Texas

Sponsors (1)

Lead Sponsor Collaborator
Caliway Biopharmaceuticals Co., Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Percentage of participants with at least 1-grade improvement reported by Investigator via live evaluation using CR-AFRS Percentage of participants with at least 1-grade improvement reported by Investigator via live evaluation using CR-AFRS compared with placebo. From baseline to 12 weeks after the final treatment
Other Percentage of participants with at least 2-grade improvement reported by Investigator via live evaluation using CR-AFRS Percentage of participants with at least 2-grade improvement reported by Investigator via live evaluation using CR-AFRS compared with placebo. From baseline to 12 weeks after the final treatment
Other Incidence of treatment-emergent adverse events (TEAEs) Number of participants experiencing TEAEs and number of individual TEAEs From baseline to 12 weeks after the final treatment
Other Incidence of clinically significant abnormal findings Number of participants with clinically significant abnormalities in laboratory tests, vital signs and physical examinations From baseline to 12 weeks after the final treatment
Primary Percentage of participants with at least 1-grade improvement reported by Investigator via photographic evaluation using the Clinician-Reported Abdominal Fat Rating Scale (CR-AFRS) Percentage of participants with at least 1-grade improvement reported by Investigator via photographic evaluation using the Clinician-Reported Abdominal Fat Rating Scale (CR-AFRS) compared with placebo. Note: The AFRS is a 5-point ordinal scale (0-5) to assess the abdominal fat level based on the presence of fat on abdomen with 1=None/Minimal, 2=Mild, 3=Moderate, 4=Severe and 5=Very Severe. From baseline to 8 weeks after the final treatment
Secondary Percentage of participants with at least 1-grade improvement reported by Investigator via photographic evaluation using CR-AFRS Percentage of participants with at least 1-grade improvement reported by Investigator via photographic evaluation using CR-AFRS compared with placebo. Note: The AFRS is a 5-point ordinal scale (0-5) to assess the abdominal fat level based on the presence of fat on abdomen with 1=None/Minimal, 2=Mild, 3=Moderate, 4=Severe and 5=Very Severe. From baseline to 4 weeks and 12 weeks after the final treatment
Secondary Percentage of participants with at least 2-grade improvement reported by Investigator via photographic evaluation using CR-AFRS Percentage of participants with at least 2-grade improvement reported by Investigator via photographic evaluation using CR-AFRS compared with placebo. Note: The AFRS is a 5-point ordinal scale (0-5) to assess the abdominal fat level based on the presence of fat on abdomen with 1=None/Minimal, 2=Mild, 3=Moderate, 4=Severe and 5=Very Severe. From baseline to 4 weeks, 8 weeks, and 12 weeks after the final treatment
Secondary Percentage of participants with at least 1-grade improvement reported by blinded physicians using CR-AFRS Percentage of participants with at least 1-grade improvement reported by blinded physicians using CR-AFRS compared with placebo. Note: The AFRS is a 5-point ordinal scale (0-5) to assess the abdominal fat level based on the presence of fat on abdomen with 1=None/Minimal, 2=Mild, 3=Moderate, 4=Severe and 5=Very Severe. From baseline to 4 weeks, 8 weeks and 12 weeks after the final treatment
Secondary Percentage of participants with at least 2-grade improvement reported by blinded physicians using CR-AFRS Percentage of participants with at least 2-grade improvement reported by blinded physicians using CR-AFRS compared with placebo. Note: The AFRS is a 5-point ordinal scale (0-5) to assess the abdominal fat level based on the presence of fat on abdomen with 1=None/Minimal, 2=Mild, 3=Moderate, 4=Severe and 5=Very Severe. From baseline to 4 weeks, 8 weeks and 12 weeks after the final treatment
Secondary Percentage of participants with at least 1-grade improvement reported by participant using the Patient-Reported Abdominal Fat Rating Scale (PR-AFRS) Percentage of participants with at least 1-grade improvement reported by participant using the Patient-Reported Abdominal Fat Rating Scale (PR-AFRS) compared with placebo. Note: The AFRS is a 5-point ordinal scale (0-5) to assess the abdominal fat level based on the presence of fat on abdomen with 1=None/Minimal, 2=Mild, 3=Moderate, 4=Severe and 5=Very Severe. From baseline to 4 weeks, 8 weeks and 12 weeks after the final treatment
Secondary Percentage of participants with at least 2-grade improvement reported by participant using PR-AFRS Percentage of participants with at least 2-grade improvement reported by participant using PR-AFRS compared with placebo. Note: The AFRS is a 5-point ordinal scale (0-5) to assess the abdominal fat level based on the presence of fat on abdomen with 1=None/Minimal, 2=Mild, 3=Moderate, 4=Severe and 5=Very Severe. From baseline to 4 weeks, 8 weeks and 12 weeks after the final treatment
Secondary Number of treatments required to first occurrence of a CR-AFRS improvement reported by blinded physicians. Number of treatments required to first occurrence of a CR-AFRS improvement reported by blinded physicians. Note: The AFRS is a 5-point ordinal scale (0-5) to assess the abdominal fat level based on the presence of fat on abdomen with 1=None/Minimal, 2=Mild, 3=Moderate, 4=Severe and 5=Very Severe. From baseline to 12 weeks after the final treatment
Secondary Percentage of participant who lose at least 150 mL of subcutaneous fat volume measured by MRI Percentage of participant who lose at least 150 mL of subcutaneous fat volume measured by MRI compared with placebo From baseline to 4 weeks and 12 weeks after the final treatment
Secondary Percentage of participant who lose at least 20% of subcutaneous fat volume compared to baseline measured by MRI Percentage of participant who lose at least 20% of subcutaneous fat volume compared to baseline measured by MRI compared with placebo From baseline to 4 weeks and 12 weeks after the final treatment
Secondary Percentage of participant who lose at least 25% of subcutaneous fat volume compared to baseline measured by MRI Percentage of participant who lose at least 25% of subcutaneous fat volume compared to baseline measured by MRI compared with placebo From baseline to 4 weeks and 12 weeks after the final treatment
Secondary Reduction of subcutaneous fat volume measured by MRI Reduction of subcutaneous fat volume compared to baseline measured by MRI From baseline to 4 weeks and 12 weeks after the final treatment
Secondary The percentage change in subcutaneous fat volumemeasured by MRI The percentage change in subcutaneous fat volume compared to baseline measured by MRI From baseline to 4 weeks and 12 weeks after the final treatment
Secondary Percentage of participant who lose at least 20 % of subcutaneous fat thickness compared to baseline measured by MRI Percentage of participant who lose at least 20 % of subcutaneous fat thickness compared to baseline measured by MRI compared with placebo From baseline to 4 weeks and 12 weeks after the final treatment
Secondary Percentage of participant who lose at least 25 % of subcutaneous fat thickness compared to baseline measured by MRI Percentage of participant who lose at least 25 % of subcutaneous fat thickness compared to baseline measured by MRI compared with placebo From baseline to 4 weeks and 12 weeks after the final treatment
Secondary Reduction of subcutaneous fat thickness measured by MRI Reduction of subcutaneous fat thickness compared to baseline measured by MRI From baseline to 4 weeks and 12 weeks after the final treatment
Secondary The percentage change in subcutaneous fat thickness measured by MRI The percentage change in subcutaneous fat thickness compared to baseline measured by MRI From baseline to 4 weeks and 12 weeks after the final treatment
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Completed NCT05234736 - A Study to Evaluate the Pharmacokinetic Profile of CBL-514 Injection in Healthy Volunteers Phase 2
Completed NCT04575467 - A Study to Evaluate the Efficacy, Safety and Tolerability of CBL-514 Injection for Reducing Subcutaneous Fat (Stage 1) Phase 2