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

Part of paid clinical trials in Encinitas, California.

Sponsor
Caliway Biopharmaceuticals Co., Ltd.
Study ID
NCT07733947
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Subcutaneous Fat

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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)

Key Dates

First listed
Jul 29, 2026
Start date
Dec 31, 2026
Status verified
Jul 2026
Primary completion
Aug 31, 2028
Completion
Sep 30, 2028

Study Design

Enrollment
300 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.
  • 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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Investigational site 1EncinitasCalifornia92024-

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By research site
Investigational· Encinitas, CA

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