A Phase 2b Study to Evaluate the Efficacy and Safety of CBL-514 Injection for Reducing Subcutaneous Fat.

Part of paid clinical trials in Omaha, Nebraska.

Sponsor
Caliway Biopharmaceuticals Co., Ltd.
Study ID
NCT06005441
Phase
PHASE2
Status
Completed

Conditions

  • Subcutaneous Fat

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Accepted

Interventions

  • CBL-514 injection — DRUG
    Provided as a ready for use injectable CBL-514 solution
  • CBL-A1 Injection — DRUG
    Provided as a ready for use injectable CBL-A1 solution
  • CBL-A2 Injection — DRUG
    Provided as a ready for use injectable CBL-A2 solution
  • 0.9% Sodium Chloride — DRUG
    Sodium Chloride (0.9% NaCl) placebo for injection

Study Details

This is a randomized, placebo-controlled, Phase 2b study to evaluate the efficacy, safety, and tolerability of CBL-514 injection compared with CBL-A1 and CBL-A2 for reducing subcutaneous fat.

Key Dates

Start date
Nov 10, 2023
Status verified
Dec 2024
Primary completion
Oct 18, 2024
Completion
Oct 18, 2024

Study Design

Enrollment
173 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: CBL-514 Injection
    Participant will receive CBL-514 administered in 2.4 mL injections, up to 120 mL per treatment session at intervals of approximately 3 weeks for up to 4 treatments.
  • Experimental: CBL-A1 Injection
    Participant will receive CBL-A1 administered in 2.4 mL injections, up to 120 mL per treatment session at intervals of approximately 3 weeks for up to 4 treatments.
  • Experimental: CBL-A2 Injection
    Participant will receive CBL-A2 administered in 2.4 mL injections, up to 120 mL per treatment session at intervals of approximately 3 weeks for up to 4 treatments.
  • Placebo Comparator: 0.9% Sodium Chloride
    Participant will receive 0.9% Sodium Chloride administered in 2.4 mL injections, up to 120 mL per treatment session at intervals of approximately 3 weeks for up to 4 treatments.

Primary Outcome Measure

Percentage of participants with at least 20% subcutaneous fat change compared to Baseline, of CBL-514 compared with placebo [ Time Frame: From Baseline to 4 weeks after the final treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
Investigational Site 1OmahaNebraska68144-

Find similar trials in Omaha, NE

By research site
Investigational· Omaha, NE

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