A Study to Evaluate the Efficacy and Safety of CBL-514 Injection for Reducing Subcutaneous Fat ( … (NCT07526974) | Clinical Trial Compass
Not Yet RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of CBL-514 Injection for Reducing Subcutaneous Fat ( SUPREME-02 )
United States320 participantsStarted 2026-10
Plain-language summary
A phase 3, randomized, double-blinded, placebo-controlled study to evaluate the efficacy, safety, and tolerability of CBL-514 injection for reducing abdominal subcutaneous fat.
Who can participate
Age range18 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 old.
* Body mass index (BMI) \> 18.5 and \< 30 kg/m2 and body weight ≥ 50 kg.
* Participant has moderate or severe abdominal fat as assessed by the Investigator on the CR-AFRS and by the participant on the PR-AFRS.
* Dissatisfaction with the abdominal fat expressed by the participant using Patient Self Rating Scale (PSRS) reported by participant.
* Participant maintained a stable lifestyle.
* Voluntarily signs the Informed Consent Form and 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 method, or who is currently pregnant or lactating. Male participant who is not committing to using condom consistently and refraining from sperm donation.
* Participant who has impeded coagulation or platelet aggregation.
* Participant has delayed wound healing or poorly controlled diabetes.
* Participant has active malignancies or is currently being evaluated for a possible malignancy.
* Participant has any uncontrolled cardiovascular disease or has any clinically significant abnormal finding in ECG at Screening.
* Participant has 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 has a visible Panniculus on …
What they're measuring
1
Percentage of participants achieving at least a 2-grade improvement from baseline on Patient Reported-Abdominal Fat Rating Scale (PR-AFRS) and a clinically meaningful reduction in abdominal fat.
Timeframe: From baseline to 4 weeks after final treatment