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

NCT07608770 | Recruiting Phase 2

• 1 other identifier: CBL-0206 (Stage 1)
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

A phase 2b, randomized, placebo-controlled study with long-term re-treatment 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 change from Baseline in abdominal fat in the CBL-514 group versus the placebo group

  Measured by MRI

  From baseline to 4 weeks after final treatment

Secondary Outcomes (3)

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

  From baseline to 12 weeks after final treatment

• Percentage of participants with at least a 1-grade improvement on Clinician Reported-Abdominal Fat Rating Scale in the CBL-514 group versus the placebo group

  From baseline to 4 weeks and 12 weeks after final treatment

• Percentage of participants with at least a 1-grade improvement on Patient Reported-Abdominal Fat Rating Scale in the CBL-514 group versus the placebo group

  From baseline to 4 weeks and 12 weeks after final treatment

Study Arms (2)

CBL-514 injection

EXPERIMENTAL

Participants will receive CBL-514 administered up to 120 mL 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 administered up to 120 mL per treatment at a 3-week interval for up to 4 treatments.

Drug: 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 DRUG

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.
• CR-AFRS and PR-AFRS score: participant has Grade 3 or Grade 4 abdominal fat as assessed both 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, 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.

You may not qualify if:

• Female participant of childbearing potential who is not willing to commit to an acceptable contraceptive method and refraining from ova donation from the time of Screening and throughout the study until 90 days after the last dose of IP, or who is currently pregnant or lactating. Fertile male participant who is not willing to commit to an acceptable contraceptive method and refraining from sperm donation from the time of the first dose of IP and throughout the study until 90 days after the last dose of IP.
• Participant was diagnosed with coagulation disorders or is receiving anticoagulant/antiplatelet therapy or medications.
• Participant has delayed wound healing or poorly controlled diabetes.
• Participant has a history of active malignancy within 3 years before Screening, 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.
• Participant has a visible Panniculus (folding fat) or visible folds of skin on the abdomen in a standing position.
• Participant has severe or very severe abdominal visceral fat.
• Participant has skin conditions which, in the opinion of the Investigator, would pose a risk to the participant if receiving the IP or interfere with the safety or efficacy evaluation.
• Participant has undergone the following procedures: a. Surgery that caused scar tissue at the treatment area; b. Previous history of abdominoplasty or abdominal liposuction within the treatment area; c. Aesthetic procedure for body contouring or fat reduction at the treatment area within 12 months before Screening; d. SC injection or transdermal application of medication at the treatment area within 4 weeks before Screening.
• Participant with contraindications to magnetic resonance imaging (MRI)
• Participant is on prescription or over-the-counter weight reduction medication, weight reduction programs, or taking oral or injectable GLP-1 agonists (eg, semaglutide, tirzepatide, liraglutide, etc.) within 6 months before Screening.
• Participant is undergoing long-term systemic steroid or immunosuppressive therapy
• Participant is taking or will take any medication that is a known strong inhibitor or inducer of CYP1A2 enzymes, sensitive CYP1A2 substrates, or medication with narrow therapeutic index during the study that, in the opinion of the Investigator, may affect the safety or efficacy evaluation of the IP or pose undue risk to the participant.
• Participant with history of hypersensitivity to local anesthesia (eg, lidocaine).
• Participant with known allergies or significant adverse reaction to the IP or any of its ingredients.

Sponsors & Collaborators

• Caliway Biopharmaceuticals Co., Ltd.: lead

Study Sites (1)

Investigational Site 1

South Yarra, Victoria, 3141, Australia

RECRUITING

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

Joanna Lu

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2026
• First Posted: May 27, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: June 4, 2026

Record last verified: 2026-06

Locations

AU (1)