A Phase 2b Study to Evaluate the Efficacy and Safety of CBL-514 Injection for Reducing Subcutaneo… (NCT06005441) | Clinical Trial Compass
CompletedPhase 2
A Phase 2b Study to Evaluate the Efficacy and Safety of CBL-514 Injection for Reducing Subcutaneous Fat.
United States173 participantsStarted 2023-11-10
Plain-language 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.
Who can participate
Age range18 Years – 64 Years
SexALL
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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 1.
✓. 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.
✕
What they're measuring
1
Percentage of participants with at least 20% subcutaneous fat change compared to Baseline, of CBL-514 compared with placebo
Timeframe: From Baseline to 4 weeks after the final treatment
. 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.