A Study to Evaluate the Efficacy, Safety, and Tolerability of CBL-514 Injection for Reducing Subc… (NCT04897412) | Clinical Trial Compass
CompletedPhase 2
A Study to Evaluate the Efficacy, Safety, and Tolerability of CBL-514 Injection for Reducing Subcutaneous Fat (Stage 2)
United States, Australia75 participantsStarted 2022-02-14
Plain-language 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.
Who can participate
Age range18 Years – 64 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 1.
✓. 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.
✕. Subject diagnosed with coagulation disorders or is receiving anticoagulant/antiplatelet therapy or medications or dietary supplements, which impede coagulation or platelet aggregation.
What they're measuring
1
Proportion of subjects who lose at least 150 mL of subcutaneous fat compared with placebo
Timeframe: From Visit 2 (Baseline) up to 8 weeks after last treatment
. 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: