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

NCT ID: NCT07140939

Last Updated: 2025-09-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2026-09-30

Brief Summary

A phase 3, randomized, double-blinded, placebo-controlled study to evaluate the efficacy, safety, and tolerability of CBL-514 injection for reducing abdominal subcutaneous fat.

Detailed Description

A total of approximately 300 adult participants with moderate or severe abdominal fat at Baseline 1 will be enrolled. Each participant will receive up to 4 treatments of allocated study drug administered subcutaneously to the abdomen, once every 3 weeks.

Conditions

Subcutaneous Fat

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

CBL-514 injection

Participants will receive CBL-514 administrated up to 120 mL (with 50 injections) per treatment at a 3-weeks interval for up to 4 treatments.

Group Type: EXPERIMENTAL

CBL-514 Injection

Intervention Type: DRUG

Provided as a ready for use injectable CBL-514 solution

Injectable 0.9% Sodium Chloride solution

Participants will receive 0.9% Sodium Chloride administrated up to 120 mL (with 50 injections) per treatment at a 3-week interval for up to 4 treatments.

Group Type: PLACEBO_COMPARATOR

0.9% Sodium Chloride

Intervention Type: OTHER

Injectable 0.9% Sodium Chloride solution as placebo

Interventions

CBL-514 Injection

Provided as a ready for use injectable CBL-514 solution

Intervention Type: DRUG

0.9% Sodium Chloride

Injectable 0.9% Sodium Chloride solution as placebo

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Male or female, aged ≥ 18 years old.

2. Body mass index (BMI) > 18.5 and < 30 kg/m2 and body weight ≥ 50 kg.

3. Participant has moderate or severe abdominal fat as assessed by the Investigator on the CR-AFRS and by the participant on the PR-AFRS.

4. Participant maintained a stable lifestyle.

5. Voluntarily signs the Informed Consent Form and 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 method, or who is currently pregnant or lactating. Male participant who is not committing to using condom consistently and refraining from sperm donation.

2. Participant who has impeded coagulation or platelet aggregation.

3. Participant has delayed wound healing or poorly controlled diabetes.

4. Participant has active malignancies or is currently being evaluated for a possible malignancy.

5. Participant has a history of trypanophobia, the extreme fear of medical procedures involving injections or needles, or who experiences vasovagal syncope and faints at the sight of blood or a needle.

6. Participant has a visible Panniculus on the abdomen in standing position.

7. Participant has severe abdominal visceral fat.

8. Participant has skin conditions, which would pose risk to the participant if receiving the IP or interfere with the safety or efficacy evaluation.

9. Participant has undergone the procedures at the treatment area that may affect IP administration.

10. Participant with contraindications to MRI imaging.

11. Participant is on prescription or over-the-counter weight reduction medication, weight reduction programs, or taking oral or injectable GLP-1 agonists.

12. Participant is undergoing long-term systemic steroid or immunosuppressive therapy which may affect the treatment area.

13. Participant is taking or will take any medication that is known strong inhibitor or inducer of CYP1A2 enzymes, sensitive CYP1A2 substrates, or medication with narrow therapeutic index.

14. Participant with history of hypersensitivity to local anesthesia.

15. Participant with known allergies or significant adverse reaction to the IP.

16. Participant with liver cirrhosis or abnormal liver function, or with any hepatic condition that interferes with the safety or efficacy assessments.

17. Participant with any renal impairment.

18. Participant has received any investigational product.

19. Participant considered to be unreliable or incapable of complying with the requirements of the protocol.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Caliway Biopharmaceuticals Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anne Sheu

Role: STUDY_DIRECTOR

Caliway Biopharmaceuticals Co., Ltd.

Locations

Investigational site 1

Encinitas, California, United States

Investigational site 2

West Palm Beach, Florida, United States

Investigational site 3

Chicago, Illinois, United States

Investigational site 4

Baton Rouge, Louisiana, United States

Investigational site 5

Hunt Valley, Maryland, United States

Investigational site 6

Omaha, Nebraska, United States

Investigational site 7

Hackensack, New Jersey, United States

Investigational site 8

New York, New York, United States

Investigational site 9

Charlotte, North Carolina, United States

Investigational site 10

Nashville, Tennessee, United States

Investigational site 11

Pflugerville, Texas, United States

Investigational site 12

Vancouver, British Columbia, Canada

Investigational site 13

Toronto, Ontario, Canada

Countries

United States; Canada

Central Contacts

Candra Chou

Role: CONTACT

CR@caliway.com.tw

+886-2-26971355 ext. 1317

Other Identifiers

CBL-0301

Identifier Type: -

Identifier Source: org_study_id