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

Last updated: December 3, 2024
Sponsor: Caliway Biopharmaceuticals Co., Ltd.
Overall Status: Completed

Phase

2

Condition

N/A

Treatment

0.9% Sodium Chloride

CBL-A2 Injection

CBL-514 injection

Clinical Study ID

NCT06005441
CBL-0205
  • Ages 18-64
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

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 andDay 1.

  3. Participant has abdominal fat graded by the Investigator as Grade 3(moderate) orGrade 4(severe) using the Clinician-Reported Abdominal Fat Rating Scale atScreening.

  4. Participant has stable body weight (identified as ≤ 3 kg weight change perparticipant 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 andduring the study.

  6. Voluntarily signs the Informed Consent Form and, in the opinion of the Investigatoror delegate, is physically and mentally capable of participating in the study andwilling to adhere to study procedures.

Exclusion

Exclusion Criteria:

  1. Female participant of childbearing potential who is not willing to commit to anacceptable contraceptive regimen from the time of Screening and throughout studyparticipation until 90 days after the last IP dose, or who is currently pregnant orlactating. Male participant who is not willing to commit to using a condom andrefraining from sperm donation from the time of the first dose of IP, throughoutstudy participation until 90 days after the last IP dose.

  2. Participant diagnosed with coagulation disorders or who is receivinganticoagulant/antiplatelet therapy or medications or dietary supplements that impedecoagulation or platelet aggregation.

  3. Participant has hemoglobin A1c (HbA1c) ≥9%, delayed wound healing, or poorlycontrolled diabetes in the opinion of Investigator, make the individual aninappropriate candidate for the study.

  4. Participant with active or prior history of malignancies within 5 years beforeScreening or currently being evaluated for a possible malignancy at Investigator'sdiscretion.

  5. Participant with a history of human immunodeficiency virus (HIV)-1 infection oractive HIV infection at Screening with positive HIV antigen/antibody combo test.

  6. Participant with a history of trypanophobia, the extreme fear of medical proceduresinvolving injections or needles, or who experiences vasovagal syncope or faints atthe 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 inhibitsafety and efficacy evaluation.

  11. Participant who has undergone the following procedures:

  12. Previous surgery that caused scar tissues on the anticipated treatment areabefore Screening or during the study.

  13. Liposuction or abdominoplasty to the region to be treated before Screening orduring the study.

  14. Aesthetic procedure for body contouring or fat reduction to the region to betreated within 12 months before Screening or during the study.

  15. Using medication that is delivered via subcutaneous injection at the treatmentarea within 4 weeks before Screening or during the study.

  16. Participant with contraindications to MRI imaging

  17. Participant is on prescription or OTC weight reduction medication, weight reductionprogram, or any GLP-1 agonist (e.g., semaglutide, terzepatide, liraglutide, etc.) (oral or injectable) within 6 months before Screening or during the study.

  18. Participant is undergoing chronic steroid or immunosuppressive therapy.

  19. Requiring continual use of any medication that is known to strongly inhibit orinduce CYP1A2 enzymes, sensitive CYP1A2 substrates or drugs with narrow therapeuticindex during the study that, in the opinion of the Investigator, may affect theevaluation of the study product or place the participant at undue risk.

  20. Unable to receive local anesthesia.

  21. Participant with known allergies or sensitivities to the IP or its components.

  22. Participant with liver cirrhosis, with inadequate liver function at Screening.

  23. Participant with any renal impairment.

  24. Use of any investigational drug or device within 3 months prior to Screening.

Study Design

Total Participants: 173
Treatment Group(s): 4
Primary Treatment: 0.9% Sodium Chloride
Phase: 2
Study Start date:
November 10, 2023
Estimated Completion Date:
October 18, 2024

Study 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.

Connect with a study center

  • Investigational Site 1

    Omaha, Nebraska 68144
    United States

    Site Not Available

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