Subcutaneous FatPhase 3NCT07733947
A Study to Evaluate the Maintenance of Efficacy and Long-term Safety of CBL-514 Injection for Reducing Subcutaneous Fat (Stage 1)
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 1 site in United States.
Trial summary
A Phase 3b, Multicenter, Two stage, Double-blind, Long term Follow up and Open-label Extension Study of Participants Who have Completed the CBL-0301 or CBL-0302 Study for Reducing Abdominal Subcutaneous Fat (Stage 1) Read more about this study
- Who is it for?
- Ages 18 years and older
- 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
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2026to Sep 2028
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant must have received at least 1 treatment of CBL 514 or Placebo and completed the FU1 visit of the parent study.
- Participant is willing to maintain a stable lifestyle.
- Participant voluntarily signs the Informed Consent Form (ICF) for Stage 1 and, in the opinion of the Investigator or delegate, is physically and mentally capable of participating in the study, and willing to adhere to the study procedures.
Who cannot join
- Participant has had or will be undergoing treatment that may affect the evaluation of the treated area.
- Participant is taking prescription or over the counter (OTC) weight reduction medication or is in a weight reduction program.
- Participant has an unstable condition or is otherwise thought to be unreliable or incapable of complying with the requirements of the protocol.
- 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 committed to using condoms consistently throughout the study. Ova and sperm donation are to occur after a certain washout period post IP treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 3b, Multicenter, Two Stage, Double-blind, Long Term Follow up and Open Label Extension Study of Participants Who Have Completed the CBL-0301 or CBL-0302 Study for Reducing Abdominal Subcutaneous Fat (Stage 1)
A Phase 3b, Multicenter, Two stage, Double-blind, Long term Follow up and Open-label Extension Study of Participants Who have Completed the CBL-0301 or CBL-0302 Study for Reducing Abdominal Subcutaneous Fat (Stage 1)
Read the detailed description
A total of approximately 300 adult participants that has received at least one study drug treatment and completed one follow-up visit in the parent studies will be enrolled. Each participant will undergo three follow-up visits, scheduled every three months in Stage 1.
- 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 | No study drug will be administered in Stage 1. Eligible participants who received prior treatment with CBL-514 in the parent studies will be included. Receives: Drug: CBL-514 Injection |
| Injectable 0.9% Sodium Chloride solution | Placebo comparator | No study drug will be administered in Stage 1. Eligible participants who received prior treatment with Placebo in the parent studies will be included. 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 with at least 1 TEAE
Measured: 6,9, and 12 months after last treatment of parent studies
Secondary outcomes (3)
Percentage of participants with at least 1 AESI
Measured: 6,9, and 12 months after last treatment of parent studies
Percentage of participants who maintain 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)
Measured by 5-point ordinal scales from Grade 1 to Grade 5 for assessing the severity of abdominal fat. The higher the grade, the more the abdominal fat.
Measured: From baseline to 6,9, and 12 months after last treatment in parent studies
Percentage change from baseline in abdominal fat
Measured by MRI
Measured: From baseline to 6,9, and 12 months after last treatment in parent studies
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study startDec 2026 (estimated)
- Primary completionAug 2028 (estimated)
- Study completionSep 2028 (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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants remain in their blinded parent-study cohorts to allow for unbiased long-term safety monitoring. No investigational product is administered during Stage 1.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 300 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
- NCT07733947
- Sponsor's protocol ID
- CBL-0303 (Stage 1)
- Status last verified
- Jul 2026
- First submitted
- 24 Jul 2026
- 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 3b, Multicenter, Two Stage, Double-blind, Long Term Follow up and Open Label Extension Study of Participants Who Have Completed the CBL-0301 or CBL-0302 Study for Reducing Abdominal Subcutaneous Fat (Stage 1)
- ClinicalTrials.gov ID
- NCT07733947
- Acronym / sponsor ID
- CBL-0303 (Stage 1)
- Conditions
- Subcutaneous Fat
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Caliway Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2026 (estimated)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 29 Jul 2026 (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 3b, Multicenter, Two stage, Double-blind, Long term Follow up and Open-label Extension Study of Participants Who have Completed the CBL-0301 or CBL-0302 Study for Reducing Abdominal Subcutaneous Fat (Stage 1)
Detailed description
A total of approximately 300 adult participants that has received at least one study drug treatment and completed one follow-up visit in the parent studies will be enrolled. Each participant will undergo three follow-up visits, scheduled every three months in Stage 1.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants remain in their blinded parent-study cohorts to allow for unbiased long-term safety monitoring. No investigational product is administered during Stage 1.
| Arm | Type | Receives |
|---|---|---|
| CBL-514 injection | Experimental | Drug: CBL-514 InjectionNo study drug will be administered in Stage 1. Eligible participants who received prior treatment with CBL-514 in the parent studies will be included. |
| Injectable 0.9% Sodium Chloride solution | Placebo comparator | Drug: 0.9 % sodium chlorideNo study drug will be administered in Stage 1. Eligible participants who received prior treatment with Placebo in the parent studies will be included. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participant must have received at least 1 treatment of CBL 514 or Placebo and completed the FU1 visit of the parent study.
- Participant is willing to maintain a stable lifestyle.
- Participant voluntarily signs the Informed Consent Form (ICF) for Stage 1 and, in the opinion of the Investigator or delegate, is physically and mentally capable of participating in the study, and willing to adhere to the study procedures.
Key exclusion criteria (4 listed)
- Participant has had or will be undergoing treatment that may affect the evaluation of the treated area.
- Participant is taking prescription or over the counter (OTC) weight reduction medication or is in a weight reduction program.
- Participant has an unstable condition or is otherwise thought to be unreliable or incapable of complying with the requirements of the protocol.
- 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 committed to using condoms consistently throughout the study. Ova and sperm donation are to occur after a certain washout period post IP treatment.
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 | Drug | Injectable 0.9% Sodium Chloride solution |
Primary outcome
Percentage of participants with at least 1 TEAE
Time frame: 6,9, and 12 months after last treatment of parent studies
3 secondary outcomes
Percentage of participants with at least 1 AESI
Time frame: 6,9, and 12 months after last treatment of parent studies
Percentage of participants who maintain 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)
Time frame: From baseline to 6,9, and 12 months after last treatment in parent studies
Percentage change from baseline in abdominal fat
Time frame: From baseline to 6,9, and 12 months after last treatment in parent studies
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.
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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.
1 site in 1 country: 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 1 site in United States.
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 3 inclusion and 4 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: opening soon, 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 1 site in United States. 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 NT Tan (+886-2-26971355 ext. 1319, 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 1 TEAE (time frame: 6,9, and 12 months after last treatment of parent studies). 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.