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

NCT07733947 | Not Yet Recruiting Phase 3 FDA Drug

• 1 other identifier: CBL-0303 (Stage 1)
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Subcutaneous Fat

Outcome Measures

Primary Outcomes (1)

• Percentage of participants with at least 1 TEAE

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

Secondary Outcomes (3)

• Percentage of participants with at least 1 AESI

  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)

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

• Percentage change from baseline in abdominal fat

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

Study Arms (2)

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.

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.

Drug: 0.9 % sodium chloride

Interventions

CBL-514 Injection DRUG

Provided as a ready for use injectable CBL-514 solution

CBL-514 injection

0.9 % sodium chloride DRUG

Injectable 0.9% Sodium Chloride solution as placebo

Injectable 0.9% Sodium Chloride solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Caliway Biopharmaceuticals Co., Ltd.: lead

Study Sites (1)

Investigational site 1

Encinitas, California, 92024, United States

Location

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Anne Sheu

  Caliway Biopharmaceuticals Co., Ltd.

  STUDY DIRECTOR

Central Study Contacts

NT Tan

CONTACT

+886-2-26971355; CR@caliwaybiopharma.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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.

Study Record Dates

• First Submitted: July 24, 2026
• First Posted: July 29, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: July 30, 2026

Record last verified: 2026-07

Locations

US (1)