Subcutaneous FatPhase 2NCT07608757
A Study to Evaluate the Efficacy, Safety, and Tolerability of CBL-514 Injection for Reducing Abdominal Subcutaneous Fat
A Phase 2 study testing CBL-514 Injection in people with Subcutaneous Fat, run by Caliway Biopharmaceuticals Co., Ltd. at 1 site in Australia.
Trial summary
A phase 2b, randomized, placebo-controlled study with long-term re-treatment 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteAustralia
- Study dates
- Feb 2027to Jun 2028
- Phase
- Phase 2
- 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.
- CR-AFRS and PR-AFRS score: participant has greater than Grade 1 abdominal fat as assessed both 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, in the opinion of the Investigator or delegate, is physically and mentally capable of participating in the study, and willing to adhere to study procedures.
- Participant has complied with Stage 1 study procedures and requirements.
Who cannot join
- Female participant of childbearing potential who is not willing to commit to an acceptable contraceptive method and refraining from ova donation from the time of Screening and throughout the study until 90 days after the last dose of IP, or who is currently pregnant or lactating. Fertile male participant who is not willing to commit to an acceptable contraceptive method and refraining from sperm donation from the time of the first dose of IP and throughout the study until 90 days after the last dose of IP.
- Participant was diagnosed with coagulation disorders or is receiving anticoagulant/antiplatelet therapy or medications.
- Participant has delayed wound healing or poorly controlled diabetes.
- Participant has a history of active malignancy within 3 years before Screening, 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.
- Participant has a visible Panniculus (folding fat) or visible folds of skin on the abdomen in a standing position.
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- Participant has severe or very severe abdominal visceral fat.
- Participant has skin conditions which, in the opinion of the Investigator, would pose a risk to the participant if receiving the IP or interfere with the safety or efficacy evaluation.
- Participant has undergone the following procedures: a. Surgery that caused scar tissue at the treatment area; b. Previous history of abdominoplasty or abdominal liposuction within the treatment area; c. Aesthetic procedure for body contouring or fat reduction at the treatment area within 12 months before Screening; d. SC injection or transdermal application of medication at the treatment area within 4 weeks before Screening.
- Participant with contraindications to magnetic resonance imaging (MRI).
- Participant is on prescription or over-the-counter weight reduction medication, weight reduction programs, or taking oral or injectable GLP-1 agonists (eg, semaglutide, tirzepatide, liraglutide, etc.) within 6 months before Screening.
- Participant is undergoing long-term systemic steroid or immunosuppressive therapy.
- Participant is taking or will take any medication that is a known strong inhibitor or inducer of CYP1A2 enzymes, sensitive CYP1A2 substrates, or medication with narrow therapeutic index during the study that, in the opinion of the Investigator, may affect the safety or efficacy evaluation of the IP or pose undue risk to the participant.
- Participant with history of hypersensitivity to local anesthesia (eg, lidocaine).
- Participant with known allergies or significant adverse reaction to the IP or any of its ingredients.
- Participant with liver cirrhosis or abnormal liver function test at Screening.
- Participant currently on dialysis or with any renal impairment at Screening.
- Participant has received any investigational product (including a device) within 3 months before Screening.
- Participant has an unstable condition (eg, psychiatric disorder, history of substance abuse within 3 years before Screening) or is otherwise thought to be unreliable or incapable of complying with the requirements of the protocol (eg, visit schedule, off-site MRI measurement).
- Participant with a known history or current diagnosis of body dysmorphic disorder or eating disorders.
- Participant has a history of vasovagal syncope.
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 2b, Randomized, Placebo-Controlled Study With Long-term Re-Treatment to Evaluate the Efficacy, Safety, and Tolerability of CBL-514 Injection for Reducing Abdominal Subcutaneous Fat (Stage 2)
A phase 2b, randomized, placebo-controlled study with long-term re-treatment to evaluate the efficacy, safety, and tolerability of CBL-514 injection for reducing abdominal subcutaneous fat.
Read the detailed description
A total of approximately 250 adult participants who have completed CBL-0206 stage 1 study with greater than Grade 1 abdominal fat, as assessed by Clincian Reported-Abdominal Fat Rating Scale (CR-AFRS) and Patient Reported-Abdominal Fat Rating Scale (PR-AFRS) at stage 1 last follow-up visit and stage 2 baseline will be enrolled. Each participant will receive up to 4 treatments of allocated study drug administered subcutaneously to the abdomen, once every 3 weeks.
- Conditions
- Subcutaneous Fat
- Being tested
- CBL-514 Injection
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
| Study group | Role | What they receive |
|---|---|---|
| CBL-514 injection | Experimental | Participants will receive CBL-514 administered up to 120 mL per treatment at a 3-weeks interval for up to 4 treatments. Receives: Drug: CBL-514 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change of abdominal fat
Measured by MRI
Measured: From baseline to 4 weeks after final treatment
Secondary outcomes (3)
Percentage change of abdominal fat
Measured by MRI
Measured: From baseline to 12 weeks after final treatment
Percentage of participants with at least a 1-grade improvement on Clinician Reported-Abdominal Fat Rating Scale (CR-AFRS)
Measured by a 5-point ordinal scale from Grade 1 to Grade 5 for assessing the severity of abdominal fat. Lower score indicates less abdominal fat. Higher score indicates more abdominal fat.
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)
Measured by a 5-point ordinal scale from Grade 1 to Grade 5 for assessing the severity of abdominal fat. Lower score indicates less abdominal fat. Higher score indicates more abdominal fat.
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 posted27 May 2026
- Study startFeb 2027 (estimated)
- Primary completionFeb 2028 (estimated)
- Study completionJun 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 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
- NCT07608757
- Sponsor's protocol ID
- CBL-0206 (Stage 2)
- Status last verified
- May 2026
- First submitted
- 20 May 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b, Randomized, Placebo-Controlled Study With Long-term Re-Treatment to Evaluate the Efficacy, Safety, and Tolerability of CBL-514 Injection for Reducing Abdominal Subcutaneous Fat (Stage 2)
- ClinicalTrials.gov ID
- NCT07608757
- Acronym / sponsor ID
- CBL-0206 (Stage 2)
- Conditions
- Subcutaneous Fat
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Caliway Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Feb 2027 (estimated)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 27 May 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 2b, randomized, placebo-controlled study with long-term re-treatment to evaluate the efficacy, safety, and tolerability of CBL-514 injection for reducing abdominal subcutaneous fat.
Detailed description
A total of approximately 250 adult participants who have completed CBL-0206 stage 1 study with greater than Grade 1 abdominal fat, as assessed by Clincian Reported-Abdominal Fat Rating Scale (CR-AFRS) and Patient Reported-Abdominal Fat Rating Scale (PR-AFRS) at stage 1 last follow-up visit and stage 2 baseline will be enrolled. Each participant will receive up to 4 treatments of allocated study drug administered subcutaneously to the abdomen, once every 3 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CBL-514 injection | Experimental | Drug: CBL-514 InjectionParticipants will receive CBL-514 administered up to 120 mL per treatment at a 3-weeks 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.
- CR-AFRS and PR-AFRS score: participant has greater than Grade 1 abdominal fat as assessed both 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, in the opinion of the Investigator or delegate, is physically and mentally capable of participating in the study, and willing to adhere to study procedures.
Key exclusion criteria (21 listed)
- Female participant of childbearing potential who is not willing to commit to an acceptable contraceptive method and refraining from ova donation from the time of Screening and throughout the study until 90 days after the last dose of IP, or who is currently pregnant or lactating. Fertile male participant who is not willing to commit to an acceptable contraceptive method and refraining from sperm donation from the time of the first dose of IP and throughout the study until 90 days after the last dose of IP.
- Participant was diagnosed with coagulation disorders or is receiving anticoagulant/antiplatelet therapy or medications.
- Participant has delayed wound healing or poorly controlled diabetes.
- Participant has a history of active malignancy within 3 years before Screening, 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.
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 |
Primary outcome
Percentage change of abdominal fat
Time frame: From baseline to 4 weeks after final treatment
Measured by MRI
3 secondary outcomes
Percentage change of abdominal fat
Time frame: From baseline to 12 weeks after final treatment
Percentage of participants with at least a 1-grade improvement on Clinician Reported-Abdominal Fat Rating Scale (CR-AFRS)
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)
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 20 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 2 study testing CBL-514 Injection in people with Subcutaneous Fat, run by Caliway Biopharmaceuticals Co., Ltd. at 1 site in Australia.
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: opening soon, as of the sponsor's last update on 20 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 Australia. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Joanna Lu (+886-2-26971355 ext. 1318, cwcr@caliwaybiopharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change of abdominal fat (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 20 Oct 2026.