NCT04897412

A Study to Evaluate the Efficacy, Safety, and Tolerability of CBL-514 Injection for Reducing Subcutaneous Fat (Stage 2)

A 2-Stage Adaptive Design, Phase 2 Study to Evaluate the Efficacy, Safety and Tolerability of CBL-514 Injection for Reducing Abdominal and Thigh Subcutaneous Fat (Stage 2)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Caliway Biopharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

The Stage 2 of this phase 2 study will be a randomized, single-blind, placebo-controlled, parallel, and multiple-dose study to assess the efficacy, safety, and subject satisfaction of CBL-514.

Detailed description

This is the 2nd stage of a 2-Stage adaptive design, phase 2 study to evaluate the efficacy, safety and tolerability of CBL- 514 injection for reducing abdominal subcutaneous fat. Stage 2 will be conducted as a single-blind, placebo-controlled study. CBL-514 will be administered via injection into the subcutaneous adipose layer on abdomen. Each subject will receive up to 4 treatments of allocated CBL-514 (2 mg/cm2) or placebo administered on abdomen, once every 4 weeks and complete 2 follow-up visits after the last treatment. The maximum dose is 600 mg per treatment depending on the level of fat accumulation on subject's abdomen.

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	Placebo	Sodium Chloride (0.9% NaCl) placebo for injection

Timeline

• Start date: 2022-02-14
• Primary completion: 2023-02-22
• Completion: 2023-03-22
• First posted: 2021-05-21
• Last updated: 2023-04-24

Locations

5 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study