A Study to Evaluate the Maintenance of Efficacy and Long-term Safety of CBL-514 Injection for Reducing Subcutaneous Fat (Stage 1)

THE STUDY

About this study

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)

Full 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)

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.

PARTICIPATION

Who may participate

Minimum age: 18 Years
Maximum age: Not reported
Sex eligibility: All sexes
Healthy volunteers: Not accepted

Only the study team can confirm eligibility. The registry criteria below are not a medical recommendation.

Full inclusion and exclusion criteria

Inclusion Criteria:

1. Participant must have received at least 1 treatment of CBL 514 or Placebo and completed the FU1 visit of the parent study.
2. Participant is willing to maintain a stable lifestyle.
3. 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.

Exclusion Criteria:

1. Participant has had or will be undergoing treatment that may affect the evaluation of the treated area.
2. Participant is taking prescription or over the counter (OTC) weight reduction medication or is in a weight reduction program.
3. Participant has an unstable condition or is otherwise thought to be unreliable or incapable of complying with the requirements of the protocol.
4. 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.

NEAR YOU

Study locations worldwide

1 site

Check the individual site’s status and contact the listed study team for current availability.

Investigational site 1

Not reported

Encinitas, California, 92024, United States

Study team contact · shared across sites

Email study team ↗View all study contacts ↓

WHAT IS BEING STUDIED

Treatments and study groups

Interventions

CBL-514 InjectionDrug

Provided as a ready for use injectable CBL-514 solution

Study groups: CBL-514 injection

0.9 % sodium chlorideDrug

Injectable 0.9% Sodium Chloride solution as placebo

Study groups: Injectable 0.9% Sodium Chloride solution

Study groups

CBL-514 injectionExperimental

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.

Interventions: Drug: CBL-514 Injection

Injectable 0.9% Sodium Chloride solutionPlacebo 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.

Interventions: Drug: 0.9 % sodium chloride

RESEARCH DETAILS

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Non randomized
Study model: Parallel
Masking: Triple
Enrolment: 300 participants · Estimated
Who is masked: Participant, Investigator, Outcomes assessor

Study model details

Participants remain in their blinded parent-study cohorts to allow for unbiased long-term safety monitoring. No investigational product is administered during Stage 1.

TIMELINE & MEASURES

Dates and outcomes

Study started: Dec 2026 · Estimated
Primary completion: Aug 2028 · Estimated
Study completion: Sep 2028 · Estimated
First registered: 29 Jul 2026 · Actual
Last registry update: 19 Oct 2026 · Actual
Status last verified: Jul 2026

Primary outcomes (1)

Percentage of participants with at least 1 TEAE

Not reported.

Time frame: 6,9, and 12 months after last treatment of parent studies

Secondary outcomes (3)

Percentage of participants with at least 1 AESI

Not reported.

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)

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.

Time frame: From baseline to 6,9, and 12 months after last treatment in parent studies

Percentage change from baseline in abdominal fat

Measured by MRI

Time frame: From baseline to 6,9, and 12 months after last treatment in parent studies

STUDY TEAM

Sponsor and contacts

Lead sponsor: Caliway Biopharmaceuticals Co., Ltd.
Sponsor type: Industry
Collaborators: Not reported
Organisation study ID: CBL-0303 (Stage 1)

Central study contacts

NT TanContactPhone: +886-2-26971355 ext. 1319Email: cwcr@caliwaybiopharma.com

Study officials

Anne SheuStudy director · Caliway Biopharmaceuticals Co., Ltd.

Contacts are provided by the registry for study enquiries. Do not use these details for marketing or promotions.

Results, documents and references

No results are posted in this registry record

This does not mean the study has no findings. Results may not yet have been submitted or published here.

No study documents are listed in this record.