A 2-Stage Adaptive Design, Phase 2 Study to Evaluate the Efficacy, Safety and Tolerability of CBL-514 Injection for Reducing Abdominal and Thigh Subcutaneous Fat (Stage 2)
Overview
- Phase
- Phase 2
- Intervention
- CBL-514 Injection
- Conditions
- Subcutaneous Fat
- Sponsor
- Caliway Biopharmaceuticals Co., Ltd.
- Enrollment
- 75
- Locations
- 5
- Primary Endpoint
- Proportion of subjects who lose at least 150 mL of subcutaneous fat compared with placebo
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The Stage 2 of this phase 2 study will be a randomized, single-blind, placebo-controlled, parallel, and multiple-dose study to assess the efficacy, safety, and subject satisfaction of CBL-514.
Detailed Description
This is the 2nd stage of a 2-Stage adaptive design, phase 2 study to evaluate the efficacy, safety and tolerability of CBL- 514 injection for reducing abdominal subcutaneous fat. Stage 2 will be conducted as a single-blind, placebo-controlled study. CBL-514 will be administered via injection into the subcutaneous adipose layer on abdomen. Each subject will receive up to 4 treatments of allocated CBL-514 (2 mg/cm2) or placebo administered on abdomen, once every 4 weeks and complete 2 follow-up visits after the last treatment. The maximum dose is 600 mg per treatment depending on the level of fat accumulation on subject's abdomen.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female, aged 18 years to 64 years old (at Screening), inclusive.
- •Body mass index (BMI) greater than 18.5 and less than 35 kg/m2 and body weight greater than or equal to 50 kg at Screening and Day
- •Subject has subcutaneous fat thickness surrounding the center of localized area of treatment. For stage 2, abdominal skinfold thickness of at least 3.00 cm (30.0 mm) and up to 8.00 cm (80.0 mm) by pinch method (measured by calibrated caliper) at Screening.
- •Subject has stable body weight (identified as less than or equal to 5% weight change per subject report) for at least 3 months before Screening and during the study.
- •Subject who has maintained a stable lifestyle (e.g. exercise, eating patterns, and smoking habit) per subject 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 subject of childbearing potential who is not willing to commit to an acceptable contraceptive regimen with her partner 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 subject who is not willing to commit to an acceptable contraceptive method.
- •Note: Subjects who are not of childbearing potential are not required to use contraception. Females with no childbearing potential are defined as who have been surgically sterilized (hysterectomy or bilateral oophorectomy) or who are post-menopausal (defined as at least 50 years with greater than or equal to 12 months of amenorrhea with a FSH greater than 40 IU/L).
- •Subject diagnosed with coagulation disorders or is receiving anticoagulant/antiplatelet therapy or medications or dietary supplements, which impede coagulation or platelet aggregation.
- •Subject has hemoglobin A1c (HbA1c) greater than or equal to 9%, delayed wound healing, or any diabetic risks which, in the opinion of Investigator, is inappropriate to participate in the study.
- •Subject has a clinically significant cardiovascular disease and abnormal findings in electrocardiogram (ECG).
- •Subject with active or prior history of malignancies within 5 years before Screening or being worked-up for a possible malignancy. Except adequately treated basal cell carcinoma of skin and in situ squamous cell carcinoma of skin would be eligible as per Investigator's discretion.
- •Subject with a history of human immunodeficiency virus (HIV)-1, infection or subjects with active HIV infection at Screening with positive HIV antigen/antibody (Ag/Ab) combo test.
- •Subject with a history of Trypanophobia, the extreme fear of medical procedures involving injections or needles, or who experience vasovagal syncope and faint or pass out at the sight of blood or a needle.
- •Subject has abnormal skin or local skin conditions at the treatment area, which in the opinion of Investigator, is inappropriate to participate in the study, including but not limited to any of the following:
- •Skin manifestations of a systemic disease,
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 4 weeks for up to a maximum of 4 treatments.
Intervention: CBL-514 Injection
Placebo: 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 4 weeks for up to a maximum of 4 treatments.
Intervention: Placebo
Outcomes
Primary Outcomes
Proportion of subjects who lose at least 150 mL of subcutaneous fat compared with placebo
Time Frame: From Visit 2 (Baseline) up to 8 weeks after last treatment
The proportion of subjects who lose at least 150 mL of subcutaneous fat as measured by ultrasound from Baseline to follow-up visits compared with placebo.
Secondary Outcomes
- Number of treatments required to first occurrence of reducing at least 150 mL of subcutaneous fat volume in CBL-514 group(From Visit 2 (Baseline) up to 8 weeks after last treatment)
- Change of subcutaneous fat volume over the treated area of the CBL-514 group compared with individual baseline(From Visit 2 (Baseline) up to 8 weeks after last treatment)
- Change of subcutaneous fat volume over the treated area compared with placebo(From Visit 2 (Baseline) up to 8 weeks after last treatment)
- Proportion of subjects who lose at least 200 mL of subcutaneous fat compared with placebo(From Visit 2 (Baseline) up to 8 weeks after last treatment)
- Evaluation of safety following up to 4 courses of CBL-514 compared with placebo(Up to 8 weeks after last treatment)