A Phase 2b, Randomized, Placebo-Controlled Factorial Study to Evaluate the Efficacy, Safety and Tolerability of CBL-514 Injection Compared With CBL-A1 and CBL-A2 for Reducing Abdominal Subcutaneous Fat
Overview
- Phase
- Phase 2
- Intervention
- CBL-514 injection
- Conditions
- Subcutaneous Fat
- Sponsor
- Caliway Biopharmaceuticals Co., Ltd.
- Enrollment
- 173
- Locations
- 1
- Primary Endpoint
- Percentage of participants with at least 20% subcutaneous fat change compared to Baseline, of CBL-514 compared with placebo
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This is a randomized, placebo-controlled, Phase 2b study to evaluate the efficacy, safety, and tolerability of CBL-514 injection compared with CBL-A1 and CBL-A2 for reducing subcutaneous fat.
Detailed Description
A total of approximately 160 adult participants with moderate or severe abdominal fat at Screening will be enrolled. Each participant will receive up to 4 treatments of allocated study drug administered subcutaneously to the abdomen, once every 3 weeks.
Investigators
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 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 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 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.
- •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) ≥9%, delayed wound healing, or poorly controlled diabetes 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 at Investigator's discretion.
- •Participant with a history of human immunodeficiency virus (HIV)-1 infection or active HIV infection at Screening with positive HIV antigen/antibody combo test.
- •Participant with a history of trypanophobia, the extreme fear of medical procedures involving injections or needles, or who experiences vasovagal syncope or 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.
- •Participant with ventral abdominal or umbilical hernia or previous repair of same.
- •Participant has abnormal skin or local skin conditions at the treatment area, which, in the opinion of Investigator, would increase risk to the participant or inhibit safety and efficacy evaluation.
Arms & Interventions
CBL-514 Injection
Participant will receive CBL-514 administered in 2.4 mL injections, up to 120 mL per treatment session at intervals of approximately 3 weeks for up to 4 treatments.
Intervention: CBL-514 injection
CBL-A1 Injection
Participant will receive CBL-A1 administered in 2.4 mL injections, up to 120 mL per treatment session at intervals of approximately 3 weeks for up to 4 treatments.
Intervention: CBL-A1 Injection
CBL-A2 Injection
Participant will receive CBL-A2 administered in 2.4 mL injections, up to 120 mL per treatment session at intervals of approximately 3 weeks for up to 4 treatments.
Intervention: CBL-A2 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 4 treatments.
Intervention: 0.9% Sodium Chloride
Outcomes
Primary Outcomes
Percentage of participants with at least 20% subcutaneous fat change compared to Baseline, of CBL-514 compared with placebo
Time Frame: From Baseline to 4 weeks after the final treatment
Measured by MRI
Secondary Outcomes
- Percentage of participants with at least 20% subcutaneous fat change compared to Baseline, of CBL-514 compared with CBL-A1 and CBL-A2(From Baseline to 4 weeks after the final treatment)
- Participants with at least 1-grade improvement reported by the Investigator using the Clinician-Reported Abdominal Fat Rating Scale (CR-AFRS)(From Baseline to 4 weeks after the final treatment)
- Participants with at least 2-grade improvement reported by the Investigator using the Clinician-Reported Abdominal Fat Rating Scale (CR-AFRS)(From Baseline to 4 weeks after the final treatment)
- Participants with at least 1-grade improvement reported by the participant using the Patient-Reported Abdominal Fat Rating Scale (PR-AFRS)(From Baseline to 4 weeks after the final treatment)
- Participants with at least 2-grade improvement reported by the participant using the Patient-Reported Abdominal Fat Rating Scale (PR-AFRS)(From Baseline to 4 weeks after the final treatment)