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A Study to Evaluate the Efficacy and Safety of CBL-514 Injection for Reducing Subcutaneous Fat | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE3

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

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.

NCT07140939•Caliway Biopharmaceuticals Co., Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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.
+9 more criteria

Locations (13)

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

Key Dates

Start Date

September 1, 2025

Primary Completion Date

July 1, 2026

Completion Date

September 1, 2026

Last Updated

September 4, 2025

Enrollment

300

ESTIMATED participants

Conditions

Subcutaneous Fat

Interventions

CBL-514 Injection

DRUG

0.9% Sodium Chloride

OTHER

Contacts

Candra Chou

CONTACT

+886-2-26971355 CR@caliway.com.tw

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 4, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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