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

NCT07733947 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2026-07-30

No results posted yet for this 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)

Conditions

  • Subcutaneous Fat

Interventions

DRUG

0.9 % sodium chloride

Injectable 0.9% Sodium Chloride solution as placebo

DRUG

CBL-514 Injection

Provided as a ready for use injectable CBL-514 solution

Sponsors & Collaborators

  • Caliway Biopharmaceuticals Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Anne Sheu · Caliway Biopharmaceuticals Co., Ltd.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-12-31
Primary Completion
2028-08-31
Completion
2028-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07733947 on ClinicalTrials.gov