Clinical trial NCT06005441: A Phase 2b Study to Evaluate the Efficacy and Safety of CBL-514 Injection for Reducing Subcutaneous Fat.
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Subcutaneous Fat
Lead sponsor: Caliway Biopharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-08-22
Enrollment: 173
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of participants with at least 20% subcutaneous fat change compared to Baseline, of CBL-514 compared with placebo
timeFrame: From Baseline to 4 weeks after the final treatment
Secondary outcomes:
measure: Percentage of participants with at least 20% subcutaneous fat change compared to Baseline, of CBL-514 compared with CBL-A1 and CBL-A2
timeFrame: From Baseline to 4 weeks after the final treatment
measure: Participants with at least 1-grade improvement reported by the Investigator using the Clinician-Reported Abdominal Fat Rating Scale (CR-AFRS)
timeFrame: From Baseline to 4 weeks after the final treatment
measure: Participants with at least 2-grade improvement reported by the Investigator using the Clinician-Reported Abdominal Fat Rating Scale (CR-AFRS)
timeFrame: From Baseline to 4 weeks after the final treatment
measure: Participants with at least 1-grade improvement reported by the participant using the Patient-Reported Abdominal Fat Rating Scale (PR-AFRS)
timeFrame: From Baseline to 4 weeks after the final treatment
measure: Participants with at least 2-grade improvement reported by the participant using the Patient-Reported Abdominal Fat Rating Scale (PR-AFRS)
timeFrame: From Baseline to 4 weeks after the final treatment
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Investigational Site 1
state: Nebraska
Study officials:
affiliation: Caliway Biopharmaceuticals Co., Ltd.
name: Anne Sheu
role: STUDY_DIRECTOR
References: