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

NCT07140939 | Not Yet Recruiting Phase 3 FDA Drug

• 1 other identifier: CBL-0301
• Study Type: interventional
• Target: 300
• Locations: 2 countries
• Sites: 13

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

Outcome Measures

Primary Outcomes (1)

• Percentage of participants with at least 13% abdominal fat change and at least a 2-grade improvement on Patient Reported Abdominal Fat Rating Scale (PR-AFRS) in the CBL-514 group versus the placebo group.

  Measured by MRI and a 5-point ordinal scale

  From baseline to 4 weeks after final treatment

Secondary Outcomes (2)

• Percentage change from baseline in abdominal fat in the CBL-514 group versus the placebo group.

  From baseline to 4 weeks after final treatment

• Percentage of participants with at least a 1-grade improvement on both Participant 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.

  From baseline to 4 weeks after final treatment

Study Arms (2)

CBL-514 injection

EXPERIMENTAL

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.

Drug: CBL-514 Injection

Injectable 0.9% Sodium Chloride solution

PLACEBO COMPARATOR

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.

Other: 0.9% Sodium Chloride

Interventions

CBL-514 Injection DRUG

Provided as a ready for use injectable CBL-514 solution

CBL-514 injection

0.9% Sodium Chloride OTHER

Injectable 0.9% Sodium Chloride solution as placebo

Injectable 0.9% Sodium Chloride solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, aged ≥ 18 years old.
• Body mass index (BMI) \> 18.5 and \< 30 kg/m2 and body weight ≥ 50 kg.
• Participant has moderate or severe abdominal fat as assessed by the Investigator on the CR-AFRS and by the participant on the PR-AFRS.
• Participant maintained a stable lifestyle.
• Voluntarily signs the Informed Consent Form and is physically and mentally capable of participating in the study, and willing to adhere to study procedures.

You may not qualify if:

• 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.
• Participant who has impeded coagulation or platelet aggregation.
• Participant has delayed wound healing or poorly controlled diabetes.
• Participant has active malignancies or is currently being evaluated for a possible malignancy.
• 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.
• Participant has a visible Panniculus on the abdomen in standing position.
• Participant has severe abdominal visceral fat.
• Participant has skin conditions, which would pose risk to the participant if receiving the IP or interfere with the safety or efficacy evaluation.
• Participant has undergone the procedures at the treatment area that may affect IP administration.
• Participant with contraindications to MRI imaging.
• Participant is on prescription or over-the-counter weight reduction medication, weight reduction programs, or taking oral or injectable GLP-1 agonists.
• Participant is undergoing long-term systemic steroid or immunosuppressive therapy which may affect the treatment area.
• 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.
• Participant with history of hypersensitivity to local anesthesia.
• Participant with known allergies or significant adverse reaction to the IP.

Sponsors & Collaborators

• Caliway Biopharmaceuticals Co., Ltd.: lead

Study Sites (13)

Investigational site 1

Encinitas, California, 92024, United States

Location

Investigational site 2

West Palm Beach, Florida, 33401, United States

Location

Investigational site 3

Chicago, Illinois, 60610, United States

Location

Investigational site 4

Baton Rouge, Louisiana, 70809, United States

Location

Investigational site 5

Hunt Valley, Maryland, 21030, United States

Location

Investigational site 6

Omaha, Nebraska, 68144, United States

Location

Investigational site 7

Hackensack, New Jersey, 07601, United States

Location

Investigational site 8

New York, New York, 10028, United States

Location

Investigational site 9

Charlotte, North Carolina, 28207, United States

Location

Investigational site 10

Nashville, Tennessee, 37215, United States

Location

Investigational site 11

Pflugerville, Texas, 78660, United States

Location

Investigational site 12

Vancouver, British Columbia, V5Z1H4, Canada

Location

Investigational site 13

Toronto, Ontario, M4W2N4, Canada

Location

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Anne Sheu

  Caliway Biopharmaceuticals Co., Ltd.

  STUDY DIRECTOR

Central Study Contacts

Candra Chou

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2025
• First Posted: August 26, 2025
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

CA (2); US (11)