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CBL-514 for Reducing Abdominal Subcutaneous Fat
NCT07608770Phase 2
Key facts
- Status
- Recruiting
- Start
- Jun 2026
- Primary completion
- Apr 2027
- Countries
- 1
- Sponsor
- Caliway Biopharmaceuticals
- Drugs
- CBL-514
- Conditions
- subcutaneous fat
01
Overview
Phase 2, randomised trial in subcutaneous fat comparing CBL-514 injection with Placebo (2 arms). Primary endpoint: Percentage change from Baseline in abdominal fat. Started Jun 2026; status: recruiting.
02
Design
2 arms- Study design
- Randomized
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
Participants will receive 0.9% Sodium Chloride administered up to 120 mL per treatment at a 3-week interval for up to 4 treatments.
03
Who it enrols
Adults with Grade 3 or 4 abdominal fat, BMI between 18.5 and 30 kg/m2, and body weight >= 50 kg. Excludes pregnant/lactating women, those with coagulation disorders, poorly controlled diabetes, active malignancy, severe visceral fat, or recent abdominal aesthetic procedures.
04
Endpoints
Primary
Percentage change from Baseline in abdominal fat
Secondary
Percentage change from Baseline in abdominal fat
Percentage of participants with at least a 1-grade improvement on Clinician Reported-Abdominal Fat Rating Scale
Percentage of participants with at least a 1-grade improvement on Patient Reported-Abdominal Fat Rating Scale
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