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

Part of paid clinical trials in Encinitas, California.

Sponsor
Caliway Biopharmaceuticals Co., Ltd.
Study ID
NCT07140939
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 — OTHER
    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
Jul 31, 2026
Status verified
Mar 2026
Primary completion
May 31, 2027
Completion
Jul 31, 2027

Study Design

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

Arms

  • Experimental: CBL-514 injection
    Participants will receive CBL-514 administrated up to 120 mL (with 50 injections) per treatment at a 3-weeks interval for up to 4 treatments.
  • Placebo Comparator: Injectable 0.9% Sodium Chloride solution
    Participants will receive 0.9% Sodium Chloride administrated up to 120 mL (with 50 injections) per treatment at a 3-week interval for up to 4 treatments.

Primary Outcome Measure

Percentage of participants with at least 13% abdominal fat change and at least a 2-grade improvement on Patient Reported Abdominal Fat Rating Scale (PR-AFRS) in the CBL-514 group versus the placebo group. [ Time Frame: From baseline to 4 weeks after final treatment ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
Investigational site 1EncinitasCalifornia92024-
Investigational site 2West Palm BeachFlorida33401-
Investigational site 3ChicagoIllinois60610-
Investigational site 4Baton RougeLouisiana70809-
Investigational site 5Hunt ValleyMaryland21030-
Investigational site 6OmahaNebraska68144-
Investigational site 7HackensackNew Jersey07601-
Investigational site 8New YorkNew York10028-
Investigational site 9CharlotteNorth Carolina28207-
Investigational site 10NashvilleTennessee37215-
Investigational site 11PflugervilleTexas78660-

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