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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBL-514 Injection | Experimental | 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. |
|
| CBL-A1 Injection | Experimental | 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. |
|
| CBL-A2 Injection | Experimental | 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. |
|
| 0.9% Sodium Chloride | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBL-514 injection | Drug | Provided as a ready for use injectable CBL-514 solution |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with at least 20% subcutaneous fat change compared to Baseline, of CBL-514 compared with placebo | Measured by MRI | From Baseline to 4 weeks after the final treatment |
| 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 | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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.
Participant diagnosed with coagulation disorders or who is receiving anticoagulant/antiplatelet therapy or medications or dietary supplements that impede coagulation or platelet aggregation.
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.
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.
Participant with a history of human immunodeficiency virus (HIV)-1 infection or active HIV infection at Screening with positive HIV antigen/antibody combo test.
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.
Participant with folding fat or skin on abdomen in standing position.
Participant with severe or very severe abdominal visceral fat.
Participant with ventral abdominal or umbilical hernia or previous repair of same.
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.
Participant who has undergone the following procedures:
Participant with contraindications to MRI imaging
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.
Participant is undergoing chronic steroid or immunosuppressive therapy.
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.
Unable to receive local anesthesia.
Participant with known allergies or sensitivities to the IP or its components.
Participant with liver cirrhosis, with inadequate liver function at Screening.
Participant with any renal impairment.
Use of any investigational drug or device within 3 months prior to Screening.
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| Name | Affiliation | Role |
|---|---|---|
| Anne Sheu | Caliway Biopharmaceuticals Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site 1 | Omaha | Nebraska | 68144 | United States |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| CBL-A1 Injection |
| Drug |
Provided as a ready for use injectable CBL-A1 solution |
|
| CBL-A2 Injection | Drug | Provided as a ready for use injectable CBL-A2 solution |
|
| 0.9% Sodium Chloride | Drug | Sodium Chloride (0.9% NaCl) placebo for injection |
|
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) | 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) | 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) | The scale is a 5-point ordinal scale to assess the abdominal fat level | From Baseline to 4 weeks after the final treatment |
| D017670 |
| Sodium Compounds |