Subcutaneous FatPhase 3NCT07526974
A Study to Evaluate the Efficacy and Safety of CBL-514 Injection for Reducing Subcutaneous Fat ( SUPREME-02 )
A Phase 3 study testing CBL-514 Injection and 0.9% Sodium Chloride in people with Subcutaneous Fat, run by Caliway Biopharmaceuticals Co., Ltd. at 14 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Subcutaneous Fat
- What is being tested?
- CBL-514 Injection and 0.9% Sodium Chloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 320 participants
- Where
- 14 sitesin 3 countries
- Study dates
- Oct 2026to Oct 2027
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- Participant has undergone the procedures at the treatment area that may affect IP administration.
- Participant with contraindications to MRI imaging.
- Participant is on prescription or over-the-counter weight reduction medication, weight reduction programs, or taking oral or injectable GLP-1 agonists.
- Participant is undergoing long-term systemic steroid or immunosuppressive therapy which may affect the treatment area.
- Participant is taking or will take any medication that is known strong inhibitor or inducer of CYP1A2 enzymes, sensitive CYP1A2 substrates, or medication with narrow therapeutic index.
- Participant with history of hypersensitivity to local anesthesia.
- Participant with known allergies or significant adverse reaction to the IP.
- Participant with liver cirrhosis or abnormal liver function, or with any hepatic condition that interferes with the safety or efficacy assessments.
- Participant with any renal impairment.
- Participant has received any investigational product.
- Participant considered to be unreliable or incapable of complying with the requirements of the protocol.
Trial locations and contacts
14 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
14 sites in 3 countries
United States11 sites
Investigational Site 3
Alpharetta, Georgia, 30005
Investigational Site 10
Arlington, Virginia, 22209
Investigational site 9
Austin, Texas, 78759
Investigational site 2
Aventura, Florida, 33180
Investigational Site 7
Canal Winchester, Ohio, 43110
Investigational Site 1
Encinitas, California, 92024
Investigational Site 4
Hunt Valley, Maryland, 21030
Investigational site 8
Nashville, Tennessee, 37215
Investigational site 6
New York, New York, 10028
Investigational site 5
Omaha, Nebraska, 68144
Investigational Site 11
Seattle, Washington, 98109
Canada2 sites
Investigational Site 13
Vancouver, British Columbia, V5Z 1H2
Investigational Site 14
Woodbridge, Ontario, L4L 8E2
About this study
Official title: 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.
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.
Read the detailed description
A total of approximately 320 adult participants with moderate or severe abdominal fat at Baseline 1 will be enrolled. Each participant will receive up to 4 treatments of allocated study drug administered subcutaneously to the abdomen, once every 4 weeks.
- Conditions
- Subcutaneous Fat
- Being tested
- CBL-514 Injection, 0.9% Sodium Chloride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBL-514 InjectionDrug
Provided as a ready for use injectable CBL-514 solution
0.9% Sodium ChlorideDrug
Injectable 0.9% Sodium Chloride solution as placebo
| Study group | Role | What they receive |
|---|---|---|
| CBL-514 injection | Experimental | Participants will receive CBL-514 administered up to 120 mL per treatment at a 4-weeks interval for up to 4 treatments. Receives: Drug: CBL-514 Injection |
| Injectable 0.9% Sodium Chloride solution | Placebo comparator | Participants will receive 0.9% Sodium Chloride administered up to 120 mL per treatment at a 4-week interval for up to 4 treatments. Receives: Drug: 0.9% Sodium Chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured by a 5-point ordinal scale and MRI
Measured: From baseline to 4 weeks after final treatment
Secondary outcomes (2)
Percentage change from baseline in abdominal fat in the CBL-514 group versus the placebo group.
Measured by MRI
Measured: From baseline to 4 weeks after final treatment
Percentage of participants with at least a 1-grade improvement on both Participant 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.
Measured by 5-point ordinal scales
Measured: From baseline to 4 weeks after final treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study startOct 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subcutaneous FatStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Caliway Biopharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anne Sheu, Study director, Caliway Biopharmaceuticals Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07526974
- Sponsor's protocol ID
- CBL-0302
- Status last verified
- Apr 2026
- First submitted
- 8 Apr 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No