A Study to Evaluate the Efficacy, Safety and Tolerability of CBL-514 Injection for Reducing Abdom… (NCT05736107) | Clinical Trial Compass
CompletedPhase 2
A Study to Evaluate the Efficacy, Safety and Tolerability of CBL-514 Injection for Reducing Abdominal Subcutaneous Fat
United States107 participantsStarted 2023-05-30
Plain-language summary
This is a randomized, placebo-controlled, Phase 2b study to evaluate the efficacy, safety, and tolerability of CBL-514 injection for reducing subcutaneous fat.
Who can participate
Age range
18 Years – 64 Years
Sex
ALL
See this in plain English?
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) \> 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 via live evaluation 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 (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 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 of 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Participants with at least 1-grade improvement reported by Investigator using the Clinician-Reported Abdominal Fat Rating Scale
Timeframe: From baseline to 12 weeks after the final treatment
. 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) greater than or equal to 9%, delayed wound healing, or poorly controlled diabetes defined as requiring a change in glucose control medications (other than day to day variations in insulin requirements) within the 6 months prior to Screening or for whom a change in glucose control medications is anticipated during the study, or any diabetic risks that, 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, with the exception of adequately treated basal cell carcinoma of skin and in situ squamous cell carcinoma of skin at Investigator's discretion.
. Participant with a history of human immunodeficiency virus (HIV)-1 infection or participant with active HIV infection at Screening with positive HIV antigen/antibody (Ag/Ab) combo test.
. Participant with a history of trypanophobia, the extreme fear of medical procedures involving injections or needles, or who experiences vasovagal syncope and 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 assessed by the Investigator using the visceral fat scale.