NCT05736107

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 107 (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 for reducing subcutaneous fat.

Detailed description

A total of approximately 110 adult participants with moderate or severe abdominal fat as assessed by the Investigator via live evaluation using the Clinician-Reported Abdominal Fat Rating Scale (CR-AFRS) at Screening will be enrolled. Each participant will receive up to 4 treatments of allocated CBL-514 (2 mg/cm²) or placebo administered subcutaneously to the abdomen, once every 3 weeks.

Conditions

• Subcutaneous Fat

Interventions

Type	Name	Description
DRUG	CBL-514 Injection	Formulated as an injectable CBL-514 solution at a concentration of 5 mg/mL.
OTHER	0.9% Sodium Chloride	Sodium Chloride (0.9% NaCl) placebo for injection

Timeline

• Start date: 2023-05-30
• Primary completion: 2024-05-20
• Completion: 2024-05-20
• First posted: 2023-02-21
• Last updated: 2024-07-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study