Recruiting
Phase 3

CBL-514

Sponsor:

Caliway Biopharmaceuticals Co., Ltd.

Code:

NCT07140939

Conditions

Subcutaneous Fat

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

CBL-514 Injection

0.9% Sodium Chloride

Study Details

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.

Conditions

Subcutaneous Fat

Study ID

NCT07140939

Start date

Sep 1, 2026

Status verified date

Sep, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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. Dissatisfaction with the abdominal fat reported by participant as 'Extremely Dissatisfied', 'Dissatisfied', or 'Slightly dissatisfied'.
5. Participant maintained a stable lifestyle.
6. 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 willing to commit to using condom consistently and refraining from sperm donation.
2. Participant who has coagulation disorders.
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 risk factors for torsade de pointes, currently has any uncontrolled cardiovascular disease, or any clinically significant finding on baseline ECG.
6. Participant has a history of peripheral arterial disease or clinically significant venous disease involving the lower extremities.
7. 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.
8. Participant has a visible Panniculus on the abdomen in standing position.
9. Participant has severe abdominal visceral fat.
10. Participant has skin conditions, which would pose risk to the participant if receiving the IP or interfere with the safety or efficacy evaluation.
11. Participant has undergone the procedures at the treatment area that may affect IP administration.
12. Participant with contraindications to MRI imaging.
13. Participant is on prescription or over-the-counter weight reduction medication, weight reduction programs, or taking oral or injectable GLP-1 agonists.
14. Participant is undergoing long-term systemic steroid or immunosuppressive therapy.
15. Participant is taking or will take any medication that is known strong inhibitor, inducer or is a sensitative substrate for CYP enzymes, or medication with narrow therapeutic index.
16. Participant with a history of hypersensitivity to local anesthesia.
17. Participant with known allergies or significant adverse reaction to the IP.
18. Participant with liver cirrhosis or abnormal liver function, or with any hepatic condition that interferes with the safety or efficacy assessments.
19. Participant with any renal impairment.
20. Participant has received any investigational product within 3 months.
21. Participant considered to be unreliable or incapable of complying with the requirements of the protocol.

Study Design

Enrollment

320 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: CBL-514 injection

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

placebo comparator: 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 4-week interval for up to 4 treatments.

Interventions

CBL-514 Injection

Provided as a ready for use injectable CBL-514 solution

0.9% Sodium Chloride

Injectable 0.9% Sodium Chloride solution as placebo

Primary outcome measure

  • Percentage of participants with at least a 2-grade improvement on Patient Reported Abdominal Fat Rating Scale (PR-AFRS) and Clinician Reported Abdominal Fat Rating Scale (CR-AFRS) in the CBL-514 group versus the placebo group. [ Time Frame: From baseline to 4 weeks after final treatment ]

Central Contacts and Locations

Locations

Investigational site 1

Recruiting

Encinitas, California, United States, 92024

Investigational site 4

Recruiting

Baton Rouge, Louisiana, United States, 70809

Investigational site 5

Recruiting

Hunt Valley, Maryland, United States, 21030

Investigational site 6

Recruiting

Omaha, Nebraska, United States, 68144

Investigational site 8

Recruiting

New York, New York, United States, 10028

Investigational site 11

Recruiting

Pflugerville, Texas, United States, 78660

More Information

Sponsor

Caliway Biopharmaceuticals Co., Ltd.

Last update posted

Sep 22, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-23. This information was provided to ClinicalTrials.gov by Caliway Biopharmaceuticals Co., Ltd. on 2026-09-22.