CBL-514 Injection for Subcutaneous Fat

NT
Overseen ByNT Tan
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Caliway Biopharmaceuticals Co., Ltd.
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

A Phase 3b, Multicenter, Two stage, Double-blind, Long term Follow up and Open-label Extension Study of Participants Who have Completed the CBL-0301 or CBL-0302 Study for Reducing Abdominal Subcutaneous Fat (Stage 1)

Who Is on the Research Team?

AS

Anne Sheu

Principal Investigator

Caliway Biopharmaceuticals Co., Ltd.

Are You a Good Fit for This Trial?

This trial is for people who have already completed a previous study (CBL-0301 or CBL-0302) aimed at reducing belly fat. Participants should be generally healthy and willing to continue with follow-up visits.

Inclusion Criteria

I am willing to keep my daily habits and routines the same during the study.
I have received CBL 514 or placebo and finished the FU1 visit in the parent study.
I have willingly signed the consent form and can follow all study procedures.

Exclusion Criteria

I have had or will have treatment that could affect how my treated area is evaluated.
Ova and sperm donation are to occur after a certain washout period post IP treatment
I am currently using weight loss medication or enrolled in a weight loss program.
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What Are the Treatments Tested in This Trial?

Interventions

  • CBL-514 Injection

Trial Overview

The study compares injections of CBL-514, a drug designed to reduce under-the-skin fat, against placebo (saltwater solution). It uses a double-blind design followed by an open-label extension for long-term safety and effectiveness.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: CBL-514 injectionExperimental Treatment1 Intervention
Group II: Injectable 0.9% Sodium Chloride solutionPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Caliway Biopharmaceuticals Co., Ltd.

Lead Sponsor

Trials
11
Recruited
550+