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NCT Number: NCT07733947

A Study to Evaluate the Maintenance of Efficacy and Long-term Safety of CBL-514 Injection for Reducing 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)

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigational site 1

Encinitas, California, 92024, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

CBL-514 injection

Drug

Provided as a ready for use injectable CBL-514 solution

0.9 % sodium chloride

Drug

Injectable 0.9% Sodium Chloride solution as placebo

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)

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

    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.

  3. Percentage change from baseline in abdominal fat

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

    Measured by MRI

Study contacts

Contact information is provided by the study sponsor or research team.

NT Tan

CONTACT

[email protected]

+886-2-26971355 ext. 1319

Sponsors and collaborators

Lead sponsor

Caliway Biopharmaceuticals Co., Ltd.

Industry

Registry information

Official study 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)

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 29, 2026
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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