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CBL-514 for Reducing Subcutaneous Fat (Stage 2)
NCT04897412Phase 2
Key facts
- Status
- Completed
- Start
- Feb 2022
- Primary completion
- Feb 2023
- Countries
- 2
- Sponsor
- Caliway Biopharmaceuticals
- Modality
- Small Molecules
- Drugs
- CBL-514
01
Overview
Phase 2, randomised, single-blind trial comparing CBL-514 Injection with Placebo (2 arms). Primary endpoint: Proportion of subjects who lose at least 150 mL of subcutaneous fat compared with placebo. Started Feb 2022; status: completed.
02
Design
2 arms- Study design
- RandomizedSingle-blind
CBL-514 Injection
CBL-514 injection (up to 600 mg) every 4 weeks for up to 4 treatments.
Placebo
0.9% Sodium Chloride injection every 4 weeks for up to 4 treatments.
03
Endpoints
Primary
Proportion of subjects who lose at least 150 mL of subcutaneous fat compared with placebo
Secondary
Proportion of subjects who lose at least 200 mL of subcutaneous fat compared with placebo
Number of treatments required to first occurrence of reducing at least 150 mL of subcutaneous fat volume in CBL-514 group
Change of subcutaneous fat volume over the treated area compared with placebo
Change of subcutaneous fat volume over the treated area of the CBL-514 group compared with individual baseline
Evaluation of safety following up to 4 courses of CBL-514 compared with placebo
04
Results
Primary endpoints met
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