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Not yet recruitingNCT07733947Updated Jul 30, 2026

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 interventional study of CBL-514 Injection and 0.9 % sodium chloride in Subcutaneous Fat, sponsored by Caliway Biopharmaceuticals Co., Ltd.. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-30.

Sponsored by Caliway Biopharmaceuticals Co., Ltd. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
300
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Subcutaneous Fat
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
300 participants (estimated)

Study arms

  • Experimental
    CBL-514 injection

    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.

    Drug: CBL-514 Injection

  • Placebo comparator
    Injectable 0.9% Sodium Chloride solution

    No study drug will be administered in Stage 1. Eligible participants who received prior treatment with Placebo in the parent studies will be included.

    Drug: 0.9 % sodium chloride

Interventions

  • DrugCBL-514 Injection

    Provided as a ready for use injectable CBL-514 solution

  • Drug0.9 % sodium chloride

    Injectable 0.9% Sodium Chloride solution as placebo

05

What researchers measure

Primary outcomes

  1. Percentage of participants with at least 1 TEAE

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

Secondary outcomes

  1. Percentage of participants with at least 1 AESI

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

  2. 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

  3. 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

06

Study locations

1 site
  • Investigational site 1
    Encinitas, California 92024, United States
07

Registry details

Key details

Study ID
NCT07733947
Lead sponsor
Caliway Biopharmaceuticals Co., Ltd.
Responsible party
Sponsor
First posted
Jul 29, 2026
Start date
Dec 2026 (estimated)
Primary completion
Aug 2028 (estimated)
Completion
Sep 2028 (estimated)
Last update
Jul 30, 2026

Study contacts

NT Tan
Contact
CR@caliwaybiopharma.com
+886-2-26971355 ext. 1319
Anne Sheu
study director · Caliway Biopharmaceuticals Co., Ltd.

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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