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
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