NCT07140939 · Caliway Biopharmaceuticals Co., Ltd.
A Study to Evaluate the Efficacy and Safety of CBL-514 Injection for Reducing Subcutaneous Fat
(SUPREME-01)
What this study is about
A phase 3, randomly assigned, double-blinded, compared against an inactive treatment study to evaluate the effectiveness, safety, and tolerability of CBL-514 injection for reducing abdominal injected under the skin fat.
View original scientific description
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.
Interventions
DRUG
CBL-514 Injection
Provided as a ready for use injectable CBL-514 solution
OTHER
0.9% Sodium Chloride
Injectable 0.9% Sodium Chloride solution as placebo
Primary outcome measures
Percentage of participants with at least a 2-grade improvement on Patient Reported Abdominal Fat Rating Scale (PR-AFRS) and Clinician Reported Abdominal Fat Rating Scale (CR-AFRS) in the CBL-514 group versus the placebo group.
Time frame: From baseline to 4 weeks after final treatment
Measured by 5-point ordinal scales
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Male or female, aged ≥ 18 years old. 2. Body mass index (BMI) \> 18.5 and \< 30 kg/m2 and body weight ≥ 50 kg. 3. Participant has moderate or severe abdominal fat as assessed by the Investigator on the CR-AFRS and by the participant on the PR-AFRS. 4. Participant maintained a stable lifestyle. 5. 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. 2. Participant who has impeded coagulation or platelet aggregation. 3. Participant has delayed wound healing or poorly controlled diabetes. 4. Participant has active malignancies or is currently being evaluated for a possible malignancy.
Where
- Encinitas, California
- West Palm Beach, Florida
- Chicago, Illinois
- Baton Rouge, Louisiana
- Hunt Valley, Maryland
- Omaha, Nebraska
- Hackensack, New Jersey
- New York, New York
- Charlotte, North Carolina
- Nashville, Tennessee
- Pflugerville, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 22, 2026 · Source of record for eligibility and locations