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CBL-514 Injection for Reducing Body Fat

Phase 2

Recruiting

Research Sponsored by Caliway Biopharmaceuticals Co., Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to 4 weeks after the final treatment

Awards & highlights

Study Summary

This trial tests 2 injections to see if they reduce fat in the body. It looks at safety, effectiveness & how people tolerate it.

Who is the study for?

Adults aged 18-64 with a BMI between 18.5 and 30, stable weight for at least three months, and moderate to severe abdominal fat are eligible. Exclusions include asymmetrical abdomen fat, MRI contraindications, recent weight loss treatments or certain medications affecting body weight or metabolism, inability to use local anesthesia, unwillingness to follow contraceptive guidelines during the study period, coagulation disorders or anticoagulant therapy users, uncontrolled diabetes or malignancy history within five years.Check my eligibility

What is being tested?

The trial is testing CBL-514 injection's effectiveness in reducing belly fat compared to two other injections (CBL-A1 and CBL-A2) and a saline placebo. Participants will be randomly assigned to receive one of these treatments under controlled conditions.See study design

What are the potential side effects?

Potential side effects may include reactions at the injection site such as pain or swelling, possible allergic responses if sensitive to ingredients in the injections; systemic effects could involve changes in liver enzymes indicative of liver stress.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to 4 weeks after the final treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to 4 weeks after the final treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to 4 weeks after the final treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of participants with at least 150 mL reduction in abdominal subcutaneous fat volume from Baseline to 8 weeks after the final treatment

Secondary outcome measures

Mean change in abdominal subcutaneous fat volume from Baseline to 4 weeks and 8 weeks after the final treatment

Percentage of participants with at least 1-grade improvement reported by the Investigator using the Clinician-Reported Abdominal Fat Rating Scale (CR-AFRS) via examining the participants in-person at 4 weeks and 8 weeks after the final treatment

Percentage of participants with at least 1-grade improvement reported by the Investigator using the Clinician-Reported Abdominal Fat Rating Scale (CR-AFRS) via photo-based system at 4 weeks and 8 weeks after the final treatment

+6 more

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: CBL-A2 InjectionExperimental Treatment1 Intervention

Participant will receive CBL-A2 administered in 2.4 mL injections, up to 120 mL per treatment session at intervals of approximately 3 weeks for up to 4 treatments.

Group II: CBL-A1 InjectionExperimental Treatment1 Intervention

Participant will receive CBL-A1 administered in 2.4 mL injections, up to 120 mL per treatment session at intervals of approximately 3 weeks for up to 4 treatments.

Group III: CBL-514 InjectionExperimental Treatment1 Intervention

Participant will receive CBL-514 administered in 2.4 mL injections, up to 120 mL per treatment session at intervals of approximately 3 weeks for up to 4 treatments.

Group IV: 0.9% Sodium ChloridePlacebo Group1 Intervention

Participant will receive 0.9% Sodium Chloride administered in 2.4 mL injections, up to 120 mL per treatment session at intervals of approximately 3 weeks for up to 4 treatments.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Caliway Biopharmaceuticals Co., Ltd.Lead Sponsor

10 Previous Clinical Trials

377 Total Patients Enrolled

6 Trials studying Subcutaneous Fat

300 Patients Enrolled for Subcutaneous Fat

Anne SheuStudy DirectorCaliway Biopharmaceuticals Co., Ltd.

6 Previous Clinical Trials

239 Total Patients Enrolled

3 Trials studying Subcutaneous Fat

192 Patients Enrolled for Subcutaneous Fat

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the protocol for this trial permit individuals below fifty to participate?

"This study requires that each participant is at least 18 years old and not exceeding 64 in age."

Answered by AI

Is the recruitment of participants ongoing for this experiment?

"From the clinicaltrials.gov listing, it is clear that this medical trial has concluded its recruitment period. Initially uploaded on December 1st 2023 and most recently updated on August 17th 2023, there are currently two other studies looking for participants."

Answered by AI

What hazards do patients face when being administered CBL-514 Injection?

"CBL-514 Injection was assessed as a level 2 on our risk scale since it has been through Phase 2 trials, indicating some safety data is available but no efficacy evidence currently exists."

Answered by AI

Who meets the criteria for participation in this research program?

"Potential participants must possess subcutaneous fat and be between 18 to 64 years old in order to qualify for this clinical trial. A total of 160 candidates are required for the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "A Phase 2b Study to Evaluate the Efficacy and Safety of CBL-514 Injection for Reducing Subcutaneous Fat.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06005441.

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