A Study to Evaluate the Efficacy and Safety of CBL-514 Injection for Reducing Subcutaneous Fat ( SUPREME-02 )

Part of paid clinical trials in Encinitas, California.

Sponsor
Caliway Biopharmaceuticals Co., Ltd.
Study ID
NCT07526974
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Subcutaneous Fat

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
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 3, randomized, double-blinded, placebo-controlled study to evaluate the efficacy, safety, and tolerability of CBL-514 injection for reducing abdominal subcutaneous fat.

Key Dates

Start date
Oct 31, 2026
Status verified
Apr 2026
Primary completion
Aug 31, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
320 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: CBL-514 injection
    Participants will receive CBL-514 administered up to 120 mL per treatment at a 4-weeks interval for up to 4 treatments.
  • Placebo Comparator: Injectable 0.9% Sodium Chloride solution
    Participants will receive 0.9% Sodium Chloride administered up to 120 mL per treatment at a 4-week interval for up to 4 treatments.

Primary Outcome Measure

Percentage of participants achieving at least a 2-grade improvement from baseline on Patient Reported-Abdominal Fat Rating Scale (PR-AFRS) and a clinically meaningful reduction in abdominal fat. [ Time Frame: From baseline to 4 weeks after final treatment ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
Investigational Site 1EncinitasCalifornia92024-
Investigational site 2AventuraFlorida33180-
Investigational Site 3AlpharettaGeorgia30005-
Investigational Site 4Hunt ValleyMaryland21030-
Investigational site 5OmahaNebraska68144-
Investigational site 6New YorkNew York10028-
Investigational Site 7Canal WinchesterOhio43110-
Investigational site 8NashvilleTennessee37215-
Investigational site 9AustinTexas78759-
Investigational Site 10ArlingtonVirginia22209-
Investigational Site 11SeattleWashington98109-

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