A Randomized, Placebo-Controlled, Phase 2b Study to Evaluate the Efficacy, Safety and Tolerability of CBL-514 Injection for Reducing Abdominal Subcutaneous Fat

Caliway Biopharmaceuticals Co., Ltd.1 site in 1 country107 target enrollmentMay 30, 2023

ConditionsSubcutaneous Fat

InterventionsCBL-514 Injection 0.9% Sodium Chloride

DrugsCBL-514 Injection

Overview

Phase: Phase 2
Intervention: CBL-514 Injection
Conditions: Subcutaneous Fat
Sponsor: Caliway Biopharmaceuticals Co., Ltd.
Enrollment: 107
Locations: 1
Primary Endpoint: Participants with at least 1-grade improvement reported by Investigator using the Clinician-Reported Abdominal Fat Rating Scale
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Detailed 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.

Registry

clinicaltrials.gov

Start Date

May 30, 2023

End Date

May 20, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Caliway Biopharmaceuticals Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female, aged 18 years to 64 years old (at Screening), inclusive.
•Body mass index (BMI) \> 18.5 and \< 30 kg/m2 and body weight ≥ 50 kg at Screening and Day
•Participant has abdominal fat graded by the Investigator as Grade 3 (moderate) or Grade 4 (severe) using the Clinician-Reported Abdominal Fat Rating Scale via live evaluation at Screening.
•Participant has stable body weight (identified as ≤ 3 kg weight change per participant report) for at least 3 months before Screening and during the study.
•Participant who has maintained a stable lifestyle (e.g., exercise, eating patterns, and smoking habit) per participant report for at least 3 months before Screening and during the study.
•Voluntarily signs the Informed Consent Form (ICF) and, in the opinion of the Investigator or delegate, is physically and mentally capable of participating in the study, and willing to adhere to study procedures.

Exclusion Criteria

•Female participant of childbearing potential who is not willing to commit to an acceptable contraceptive regimen from the time of Screening and throughout study participation until 90 days after the last IP dose, or who is currently pregnant or lactating. Male participant who is not willing to commit to using of a condom and refraining from sperm donation from the time of the first dose of IP, throughout study participation until 90 days after the last IP dose.
•Note: Participants who are not of childbearing potential are not required to use contraception. Females not of childbearing potential are defined as those who have been surgically sterilized (hysterectomy or bilateral oophorectomy) or who are post-menopausal (defined as at least 50 years of age with greater than or equal to 12 months of amenorrhea with a follicle stimulating hormone (FSH) greater than 30 IU/L).
•Participant diagnosed with coagulation disorders or who is receiving anticoagulant/antiplatelet therapy or medications or dietary supplements that impede coagulation or platelet aggregation.
•Participant has hemoglobin A1c (HbA1c) greater than or equal to 9%, delayed wound healing, or poorly controlled diabetes defined as requiring a change in glucose control medications (other than day to day variations in insulin requirements) within the 6 months prior to Screening or for whom a change in glucose control medications is anticipated during the study, or any diabetic risks that, in the opinion of Investigator, make the individual an inappropriate candidate for the study.
•Participant with active or prior history of malignancies within 5 years before Screening or currently being evaluated for a possible malignancy, with the exception of adequately treated basal cell carcinoma of skin and in situ squamous cell carcinoma of skin at Investigator's discretion.
•Participant with a history of human immunodeficiency virus (HIV)-1 infection or participant with active HIV infection at Screening with positive HIV antigen/antibody (Ag/Ab) combo test.
•Participant with a history of trypanophobia, the extreme fear of medical procedures involving injections or needles, or who experiences vasovagal syncope and faints at the sight of blood or a needle.
•Participant with folding fat or skin on abdomen in standing position.
•Participant with severe or very severe abdominal visceral fat assessed by the Investigator using the visceral fat scale.
•Participant with ventral abdominal or umbilical hernia or previous repair of same.

Arms & Interventions

CBL-514 Injection

Participant will receive CBL-514 2 mg/cm² administered in 2.4 mL injections, up to 120 mL per treatment session at intervals of approximately 3 weeks for up to a maximum of 4 treatments.

Intervention: CBL-514 Injection

0.9% Sodium Chloride

Participant will receive 0.9% Sodium Chloride administered in 2.4 mL injections, up to 120 mL per treatment session at intervals of approximately 3 weeks for up to a maximum of 4 treatments.

Intervention: 0.9% Sodium Chloride

Outcomes

Primary Outcomes

Participants with at least 1-grade improvement reported by Investigator using the Clinician-Reported Abdominal Fat Rating Scale

Time Frame: From baseline to 12 weeks after the final treatment

The scale is a 5-point ordinal scale to assess the abdominal fat level

Secondary Outcomes

Participants with at least 1-grade improvement reported by participant using the Patient-Reported Abdominal Fat Rating Scale(From baseline to 4 weeks, 8 weeks and 12 weeks after the final treatment)
Change in subcutaneous fat compared to baseline(From baseline to 4 weeks and 12 weeks after the final treatment)
Participants with at least 1-grade improvement reported by Investigator using the Clinician-Reported Abdominal Fat Rating Scale(From baseline to 4 weeks and 8 weeks after the final treatment)
Participants with at least 2-grade improvement reported by Investigator using the Clinician-Reported Abdominal Fat Rating Scale(From baseline to 4 weeks, 8 weeks and 12 weeks after the final treatment)