Subcutaneous FatPhase 3SUPREME-01NCT07140939
A Study to Evaluate the Efficacy and Safety of CBL-514 Injection for Reducing Subcutaneous Fat
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 13 sites in 2 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
- 13 sitesin 2 countries
- Study dates
- 1 Sep 2026to Sep 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 reported by participant as 'Extremely Dissatisfied', 'Dissatisfied', or 'Slightly dissatisfied'.
- 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 willing to commit to using condom consistently and refraining from sperm donation.
- Participant who has coagulation disorders.
- 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 risk factors for torsade de pointes, currently has any uncontrolled cardiovascular disease, or any clinically significant finding on baseline ECG.
- Participant has a history of peripheral arterial disease or clinically significant venous disease involving the lower extremities.
Show all 21Show fewer
- 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.
- 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.
- Participant is taking or will take any medication that is known strong inhibitor, inducer or is a sensitative substrate for CYP enzymes, or medication with narrow therapeutic index.
- Participant with a 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 within 3 months.
- Participant considered to be unreliable or incapable of complying with the requirements of the protocol.
Trial locations and contacts
13 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
13 sites in 2 countries
United States11 sites, 11 recruiting
- Recruiting
Investigational site 4
Baton Rouge, Louisiana, 70809
- Not yet recruiting
Investigational site 9
Charlotte, North Carolina, 28207
- Not yet recruiting
Investigational site 3
Chicago, Illinois, 60610
- Recruiting
Investigational site 1
Encinitas, California, 92024
- Not yet recruiting
Investigational site 7
Hackensack, New Jersey, 07601
- Recruiting
Investigational site 5
Hunt Valley, Maryland, 21030
- Not yet recruiting
Investigational site 10
Nashville, Tennessee, 37215
- Recruiting
Investigational site 8
New York, New York, 10028
- Recruiting
Investigational site 6
Omaha, Nebraska, 68144
- Recruiting
Investigational site 11
Pflugerville, Texas, 78660
- Not yet recruiting
Investigational site 2
West Palm Beach, Florida, 33401
Canada2 sites, 2 recruiting
- Not yet recruiting
Investigational site 13
Toronto, Ontario, M4W2N4
- Not yet recruiting
Investigational site 12
Vancouver, British Columbia, V5Z1H4
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 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 ChlorideOther
Injectable 0.9% Sodium Chloride solution as placebo
| Study group | Role | What they receive |
|---|---|---|
| CBL-514 injection | Experimental | Participants will receive CBL-514 administrated up to 120 mL (with 50 injections) 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 administrated up to 120 mL (with 50 injections) per treatment at a 4-week interval for up to 4 treatments. Receives: Other: 0.9% Sodium Chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured by 5-point ordinal scales
Measured: From baseline to 4 weeks after final treatment
Secondary outcomes (2)
Percent 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 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.
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 posted26 Aug 2025
- Study start1 Sep 2026
- Primary completionJul 2027 (estimated)
- Study completionSep 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
- NCT07140939
- Sponsor's protocol ID
- CBL-0301
- Acronym
- SUPREME-01
- Status last verified
- Sep 2026
- First submitted
- 21 Aug 2025
- Last updated
- 19 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07140939
- Acronym / sponsor ID
- SUPREME-01 / CBL-0301
- Conditions
- Subcutaneous Fat
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Caliway Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 26 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A total of approximately 320 adult participants with moderate or severe abdominal fat at Baseline will be enrolled. Each participant will receive up to 4 treatments of allocated study drug administered subcutaneously to the abdomen, once every 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBL-514 injection | Experimental | Drug: CBL-514 InjectionParticipants will receive CBL-514 administrated up to 120 mL (with 50 injections) per treatment at a 4-weeks interval for up to 4 treatments. |
| Injectable 0.9% Sodium Chloride solution | Placebo comparator | Other: 0.9% Sodium ChlorideParticipants will receive 0.9% Sodium Chloride administrated up to 120 mL (with 50 injections) per treatment at a 4-week interval for up to 4 treatments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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 reported by participant as 'Extremely Dissatisfied', 'Dissatisfied', or 'Slightly dissatisfied'.
- Participant maintained a stable lifestyle.
Key exclusion criteria (21 listed)
- 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 willing to commit to using condom consistently and refraining from sperm donation.
- Participant who has coagulation disorders.
- 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 risk factors for torsade de pointes, currently has any uncontrolled cardiovascular disease, or any clinically significant finding on baseline ECG.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBL-514 InjectionProvided as a ready for use injectable CBL-514 solution | Drug | CBL-514 injection |
| 0.9% Sodium ChlorideInjectable 0.9% Sodium Chloride solution as placebo | Other | Injectable 0.9% Sodium Chloride solution |
Primary outcome
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
2 secondary outcomes
Percent change from baseline in abdominal fat in the CBL-514 group versus the placebo group.
Time frame: From baseline to 4 weeks after final treatment
Percentage of participants with at least a 1-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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
Related trials for Subcutaneous Fat
Active, not recruitingPhase 1/2
A Trial to Learn How Safe AZD9550 Monotherapy and Combined With AZD6234 is in People With or Without Type 2 Diabetes Who Are Living With Obesity and Overweight
Overweight and Obesity
RecruitingPhase 3
Efficacy and Safety of Mibavademab in Adult and Pediatric Patients With Generalized Lipodystrophy
Generalized Lipodystrophy
RecruitingObservational study
Sonographic Thigh Adjustment Ratio and Subcutaneous Fat Thickness as Predictors of Genicular Nerve Block Response in Knee Osteoarthritis
Knee Osteoarthritis, Chronic Knee Pain
Not yet recruitingPhase 2
A Study to Evaluate the Efficacy, Safety, and Tolerability of CBL-514 Injection for Reducing Abdominal Subcutaneous Fat
Subcutaneous Fat
Not yet recruitingPhase 3
A Study to Evaluate the Efficacy and Safety of CBL-514 Injection for Reducing Subcutaneous Fat ( SUPREME-02 )
Subcutaneous Fat
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anne Sheu study director
Caliway Biopharmaceuticals Co., Ltd.
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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 13 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Candra Chou (+886-2-26971355 ext. 1317, cwcr@caliwaybiopharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.