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)

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)

Study Overview

• Status: Not yet recruiting
• Conditions: Subcutaneous Fat
• Intervention / Treatment: Drug: CBL-514 Injection; Drug: 0.9 % sodium chloride

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.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: NT Tan; Phone Number: 1319 +886-2-26971355; Email: CR@caliwaybiopharma.com

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Provided as a ready for use injectable CBL-514 solution
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; Injectable 0.9% Sodium Chloride solution as placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of participants with at least 1 TEAE	6,9, and 12 months after last treatment of parent studies

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants with at least 1 AESI		6,9, and 12 months after last treatment of parent studies
Percentage change from baseline in abdominal fat	Measured by MRI	From baseline to 6,9, and 12 months after last treatment in 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.	From baseline to 6,9, and 12 months after last treatment in parent studies

Collaborators and Investigators

• Sponsor: Caliway Biopharmaceuticals Co., Ltd.
• Investigators: Study Director: Anne Sheu, Caliway Biopharmaceuticals Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: July 24, 2026
• First Submitted That Met QC Criteria: July 24, 2026
• First Posted (Actual): July 29, 2026

Study Record Updates

• Last Update Posted (Actual): July 30, 2026
• Last Update Submitted That Met QC Criteria: July 28, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Inorganic Chemicals; Chlorine Compounds; Sodium Compounds; Chlorides; Hydrochloric Acid; Sodium Chloride
• Other Study ID Numbers: CBL-0303 (Stage 1)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No