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

December 3, 2024 updated by: Caliway Biopharmaceuticals Co., Ltd.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
173

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Nebraska
      • Omaha, Nebraska, United States, 68144
        • Investigational Site 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Male or female, aged 18 years to 64 years old (at Screening), inclusive.
  2. Body mass index (BMI) >18.5 and < 30 kg/m2 and body weight ≥ 50 kg at Screening and Day 1.
  3. Participant has abdominal fat graded by the Investigator as Grade 3(moderate) or Grade 4(severe) using the Clinician-Reported Abdominal Fat Rating Scale at Screening.
  4. Participant has stable body weight (identified as ≤ 3 kg weight change per participant report) for at least 3 months before Screening and during the study.
  5. Participant who has maintained a stable lifestyle (e.g., exercise, eating patterns, and smoking habit) per participant report for at least 3 months before Screening and during the study.
  6. Voluntarily signs the Informed Consent Form and, in the opinion of the Investigator or delegate, is physically and mentally capable of participating in the study and willing to adhere to study procedures.

Exclusion Criteria:

  1. Female participant of childbearing potential who is not willing to commit to an acceptable contraceptive regimen from the time of Screening and throughout study participation until 90 days after the last IP dose, or who is currently pregnant or lactating. Male participant who is not willing to commit to using a condom and refraining from sperm donation from the time of the first dose of IP, throughout study participation until 90 days after the last IP dose.
  2. Participant diagnosed with coagulation disorders or who is receiving anticoagulant/antiplatelet therapy or medications or dietary supplements that impede coagulation or platelet aggregation.
  3. Participant has hemoglobin A1c (HbA1c) ≥9%, delayed wound healing, or poorly controlled diabetes in the opinion of Investigator, make the individual an inappropriate candidate for the study.
  4. Participant with active or prior history of malignancies within 5 years before Screening or currently being evaluated for a possible malignancy at Investigator's discretion.
  5. Participant with a history of human immunodeficiency virus (HIV)-1 infection or active HIV infection at Screening with positive HIV antigen/antibody combo test.
  6. Participant with a history of trypanophobia, the extreme fear of medical procedures involving injections or needles, or who experiences vasovagal syncope or faints at the sight of blood or a needle.
  7. Participant with folding fat or skin on abdomen in standing position.
  8. Participant with severe or very severe abdominal visceral fat.
  9. Participant with ventral abdominal or umbilical hernia or previous repair of same.
  10. Participant has abnormal skin or local skin conditions at the treatment area, which, in the opinion of Investigator, would increase risk to the participant or inhibit safety and efficacy evaluation.

  11. Participant who has undergone the following procedures:

    1. Previous surgery that caused scar tissues on the anticipated treatment area before Screening or during the study.
    2. Liposuction or abdominoplasty to the region to be treated before Screening or during the study.
    3. Aesthetic procedure for body contouring or fat reduction to the region to be treated within 12 months before Screening or during the study.
    4. Using medication that is delivered via subcutaneous injection at the treatment area within 4 weeks before Screening or during the study.
  12. Participant with contraindications to MRI imaging
  13. Participant is on prescription or OTC weight reduction medication, weight reduction program, or any GLP-1 agonist (e.g., semaglutide, terzepatide, liraglutide, etc.) (oral or injectable) within 6 months before Screening or during the study.
  14. Participant is undergoing chronic steroid or immunosuppressive therapy.
  15. Requiring continual use of any medication that is known to strongly inhibit or induce CYP1A2 enzymes, sensitive CYP1A2 substrates or drugs with narrow therapeutic index during the study that, in the opinion of the Investigator, may affect the evaluation of the study product or place the participant at undue risk.
  16. Unable to receive local anesthesia.
  17. Participant with known allergies or sensitivities to the IP or its components.
  18. Participant with liver cirrhosis, with inadequate liver function at Screening.
  19. Participant with any renal impairment.
  20. Use of any investigational drug or device within 3 months prior to Screening.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: CBL-514 Injection
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.
Drug: CBL-514 injection
Provided as a ready for use injectable CBL-514 solution
Experimental: CBL-A1 Injection
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.
Drug: CBL-A1 Injection
Provided as a ready for use injectable CBL-A1 solution
Experimental: CBL-A2 Injection
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.
Drug: CBL-A2 Injection
Provided as a ready for use injectable CBL-A2 solution
Placebo Comparator: 0.9% Sodium Chloride
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.
Drug: 0.9% Sodium Chloride
Sodium Chloride (0.9% NaCl) placebo for injection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of participants with at least 20% subcutaneous fat change compared to Baseline, of CBL-514 compared with placebo
Time Frame: From Baseline to 4 weeks after the final treatment
Measured by MRI
From Baseline to 4 weeks after the final treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of participants with at least 20% subcutaneous fat change compared to Baseline, of CBL-514 compared with CBL-A1 and CBL-A2
Time Frame: From Baseline to 4 weeks after the final treatment
Measured by MRI
From Baseline to 4 weeks after the final treatment
Participants with at least 1-grade improvement reported by the Investigator using the Clinician-Reported Abdominal Fat Rating Scale (CR-AFRS)
Time Frame: From Baseline to 4 weeks after the final treatment
The scale is a 5-point ordinal scale to assess the abdominal fat level
From Baseline to 4 weeks after the final treatment
Participants with at least 2-grade improvement reported by the Investigator using the Clinician-Reported Abdominal Fat Rating Scale (CR-AFRS)
Time Frame: From Baseline to 4 weeks after the final treatment
The scale is a 5-point ordinal scale to assess the abdominal fat level
From Baseline to 4 weeks after the final treatment
Participants with at least 1-grade improvement reported by the participant using the Patient-Reported Abdominal Fat Rating Scale (PR-AFRS)
Time Frame: From Baseline to 4 weeks after the final treatment
The scale is a 5-point ordinal scale to assess the abdominal fat level
From Baseline to 4 weeks after the final treatment
Participants with at least 2-grade improvement reported by the participant using the Patient-Reported Abdominal Fat Rating Scale (PR-AFRS)
Time Frame: From Baseline to 4 weeks after the final treatment
The scale is a 5-point ordinal scale to assess the abdominal fat level
From Baseline to 4 weeks after the final treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Caliway Biopharmaceuticals Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Anne Sheu, Caliway Biopharmaceuticals Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 10, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 18, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 18, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 10, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 22, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 5, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CBL-0205

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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