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

Part of paid clinical trials in Pflugerville, Texas.

Sponsor
Caliway Biopharmaceuticals Co., Ltd.
Study ID
NCT05736107
Phase
PHASE2
Status
Completed

Conditions

  • Subcutaneous Fat

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Accepted

Interventions

  • CBL-514 Injection — DRUG
    Formulated as an injectable CBL-514 solution at a concentration of 5 mg/mL.
  • 0.9% Sodium Chloride — OTHER
    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 for reducing subcutaneous fat.

Key Dates

Start date
May 30, 2023
Status verified
Jul 2024
Primary completion
May 20, 2024
Completion
May 20, 2024

Study Design

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

Arms

  • Experimental: CBL-514 Injection
    Participant will receive CBL-514 2 mg/cm² administered in 2.4 mL injections, up to 120 mL per treatment session at intervals of approximately 3 weeks for up to a maximum of 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 a maximum of 4 treatments.

Primary Outcome Measure

Participants with at least 1-grade improvement reported by Investigator using the Clinician-Reported Abdominal Fat Rating Scale [ Time Frame: From baseline to 12 weeks after the final treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
Investigational site 1PflugervilleTexas78660-

Find similar trials in Pflugerville, TX

By research site
Investigational· Pflugerville, TX

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