Not Yet RecruitingPhase 3

A Study to Evaluate the Efficacy and Safety of CBL-514 Injection for Reducing Subcutaneous Fat

United States300 participantsStarted 2026-07

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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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.
✓. 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 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 the abdomen in standing position.
✕. Participant has severe abdominal visceral fat.
✕. Participant has skin conditions, which would pose risk to the participant if receiving the IP or interfere with the safety or efficacy evaluation.

What they're measuring

Percentage of participants with at least 13% abdominal fat change and at least a 2-grade improvement on Patient Reported Abdominal Fat Rating Scale (PR-AFRS) in the CBL-514 group versus the placebo group.

Timeframe: From baseline to 4 weeks after final treatment

Trial details

NCT IDNCT07140939

SponsorCaliway Biopharmaceuticals Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-05

Contact for this trial

Candra Chou

+886-2-26971355 CR@caliway.com.tw

View on ClinicalTrials.gov More Subcutaneous Fat trials