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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04897412




Registration number
NCT04897412
Ethics application status
Date submitted
18/05/2021
Date registered
21/05/2021
Date last updated
24/04/2023

Titles & IDs
Public title
A Study to Evaluate the Efficacy, Safety, and Tolerability of CBL-514 Injection for Reducing Subcutaneous Fat (Stage 2)
Scientific title
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)
Secondary ID [1] 0 0
CBL-0202(Stage 2)
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Subcutaneous Fat 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - CBL-514 Injection
Other interventions - Placebo

Experimental: 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.

Placebo comparator: 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.


Treatment: Drugs: CBL-514 Injection
Formulated as an injectable CBL-514 solution at a concentration of 5 mg/mL.

Other interventions: Placebo
Sodium Chloride (0.9% NaCl) placebo for injection
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of subjects who lose at least 150 mL of subcutaneous fat compared with placebo
Timepoint [1] 0 0
From Visit 2 (Baseline) up to 8 weeks after last treatment
Secondary outcome [1] 0 0
Proportion of subjects who lose at least 200 mL of subcutaneous fat compared with placebo
Timepoint [1] 0 0
From Visit 2 (Baseline) up to 8 weeks after last treatment
Secondary outcome [2] 0 0
Number of treatments required to first occurrence of reducing at least 150 mL of subcutaneous fat volume in CBL-514 group
Timepoint [2] 0 0
From Visit 2 (Baseline) up to 8 weeks after last treatment
Secondary outcome [3] 0 0
Change of subcutaneous fat volume over the treated area compared with placebo
Timepoint [3] 0 0
From Visit 2 (Baseline) up to 8 weeks after last treatment
Secondary outcome [4] 0 0
Change of subcutaneous fat volume over the treated area of the CBL-514 group compared with individual baseline
Timepoint [4] 0 0
From Visit 2 (Baseline) up to 8 weeks after last treatment
Secondary outcome [5] 0 0
Evaluation of safety following up to 4 courses of CBL-514 compared with placebo
Timepoint [5] 0 0
Up to 8 weeks after last treatment

Eligibility
Key inclusion criteria
1. Male or female, aged 18 years to 64 years old (at Screening), inclusive.
2. 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 1.
3. 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.
4. 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.
5. 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.
6. 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.
Minimum age
18 Years
Maximum age
64 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. 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).
2. Subject diagnosed with coagulation disorders or is receiving anticoagulant/antiplatelet therapy or medications or dietary supplements, which impede coagulation or platelet aggregation.
3. 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.
4. Subject has a clinically significant cardiovascular disease and abnormal findings in electrocardiogram (ECG).
5. 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.
6. 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.
7. 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.
8. 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:

1. Skin manifestations of a systemic disease,
2. Any abnormality of the skin or soft tissues of the area to be treated,
3. Grade III cellulite (Nürnberger and Muller scale, Nürnberger F, 1978) at the area to be treated,
4. Skin folding and fat folding on abdomen
5. Sensory loss or dysesthesia in the area to be treated,
6. Evidence of any cause of enlargement in the area to be treated other than localized abdominal or thigh subcutaneous fat,
7. Tattoos on the area to be treated.
9. Subject who has undergone the following procedures:

1. Previous surgery which caused scar tissues on the anticipated treatment area before Screening or during the study, except laparoscopic surgery and surgery which causes very small scar tissues would be eligible as per Investigator's discretion,
2. Liposuction to the region to be treated before Screening or during the study,
3. Esthetic procedure e.g. cryolipolysis, ultrasonic lipolysis, LLLT, lipolysis injection to the region to be treated within 12 months before Screening or during the study.
4. Using medication which is delivered via subcutaneous injection at the treatment area during the study period.
10. Subject is on prescription or OTC weight reduction medication or weight reduction programs within 3 months before Screening or during the study.
11. Subject is undergoing chronic steroid or immunosuppressive therapy, with the exception of oral steroid inhalation indicated for asthma management or topical steroid application for skin conditions that are not directly applied or indirectly affect the treatment area.
12. Requiring continual use of the following therapeutic agents during the study: terfenadine (Teldane), buspirone (Buspar), fexofenadine (Fexotabs, Tefodine, Telfast, Xergic, Allegra, etc.), any medication that is known to strongly inhibit or induce CYP enzymes, sensitive CYP substrates or drugs with narrow therapeutic index, in the opinion of the investigator, may affect the evaluation of the study product or place the participant at undue risk.

If a subject needs to use the above mentioned therapeutic agents during the study for any reason, these therapeutic agents should not be used at least for 2 days prior to dosing and until 1 day post-dose.
13. Unable to receive topical anesthesia (e.g., history of hypersensitivity to lidocaine).
14. Subjects with known allergies or sensitivities to the study treatment or its components.
15. Subjects with liver cirrhosis or with inadequate liver function at Screening defined as aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALKP), total bilirubin (TBIL), or gamma-glutamyl transferase (GGT) greater than 3.0 × upper limit of normal (ULN), or with any hepatic medical condition that would interfere with assessment of safety or efficacy or compromise the subject's ability to undergo study procedures or provide informed consent.
16. Subjects with any renal impairment, defined as abnormal serum creatinine, and urea greater than 1.5 × ULN or estimated glomerular filtration rate (eGFR) less than 90 mL/min/1.73 m2. Subjects who are currently on dialysis should be excluded.

Subjects with an eGFR greater than or equal to 60 and less than 90 mL/min/1.73 m2 at Screening should be evaluated by the Investigator to exclude pre-existing renal disease or associated dysfunction. If mild decrease in eGFR is assessed by the Investigator as not clinically significant or not related to dysfunction, the subjects may be eligible upon the Investigator's assessment.
17. Use of other investigational drug or device within 12 weeks prior to Screening.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/02/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/03/2023
Sample size
Target
Accrual to date
Final
75
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Investigational site 5 - Melbourne
Recruitment postcode(s) [1] 0 0
3141 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Illinois
Country [2] 0 0
United States of America
State/province [2] 0 0
Nebraska
Country [3] 0 0
United States of America
State/province [3] 0 0
Tennessee
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Caliway Biopharmaceuticals Co., Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT04897412
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Anne Sheu
Address 0 0
Caliway Biopharmaceuticals Co., Ltd.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04897412