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

Sponsor
Caliway Biopharmaceuticals Co., Ltd.
Study ID
NCT07608770
Phase
PHASE2
Status
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 2b, randomized, placebo-controlled study with long-term re-treatment to evaluate the efficacy, safety, and tolerability of CBL-514 injection for reducing abdominal subcutaneous fat

Key Dates

Start date
Jun 30, 2026
Status verified
Jun 2026
Primary completion
Apr 30, 2027
Completion
Nov 30, 2027

Study Design

Enrollment
250 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 3-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 3-week interval for up to 4 treatments.

Primary Outcome Measure

Percentage change from Baseline in abdominal fat in the CBL-514 group versus the placebo group [ Time Frame: From baseline to 4 weeks after final treatment ]

Central Contacts

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