NCT06005441

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

A Phase 2b, Randomized, Placebo-Controlled Factorial Study to Evaluate the Efficacy, Safety and Tolerability of CBL-514 Injection Compared With CBL-A1 and CBL-A2 for Reducing Abdominal Subcutaneous Fat

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 173 (actual)
• Sponsor: Caliway Biopharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

A total of approximately 160 adult participants with moderate or severe abdominal fat at Screening will be enrolled. Each participant will receive up to 4 treatments of allocated study drug administered subcutaneously to the abdomen, once every 3 weeks.

Conditions

• Subcutaneous Fat

Interventions

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

Timeline

• Start date: 2023-11-10
• Primary completion: 2024-10-18
• Completion: 2024-10-18
• First posted: 2023-08-22
• Last updated: 2024-12-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study