A Study to Evaluate the Efficacy and Safety of CBL-514 Injection for Reducing Subcutaneous Fat ( SUPREME-02 )

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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Subcutaneous Fat
• Intervention / Treatment: Drug: CBL-514 Injection; Drug: 0.9% Sodium Chloride

Detailed Description

A total of approximately 320 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 4 weeks.

• Study Type: Interventional
• Enrollment (Estimated): 320
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Shannon Wu; Phone Number: 1316 +886-2-26971355; Email: CR@caliway.com.tw

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3141
      • Investigational site 12
• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1H2
      • Investigational site 13
  • Ontario
    • Woodbridge, Ontario, Canada, L4L 8E2
      • Investigational site 14
• United States
  • California
    • Encinitas, California, United States, 92024
      • Investigational Site 1
  • Florida
    • Aventura, Florida, United States, 33180
      • Investigational Site 2
  • Georgia
    • Alpharetta, Georgia, United States, 30005
      • Investigational Site 3
  • Maryland
    • Hunt Valley, Maryland, United States, 21030
      • Investigational Site 4
  • Nebraska
    • Omaha, Nebraska, United States, 68144
      • Investigational Site 5
  • New York
    • New York, New York, United States, 10028
      • Investigational Site 6
  • Ohio
    • Canal Winchester, Ohio, United States, 43110
      • Investigational Site 7
  • Tennessee
    • Nashville, Tennessee, United States, 37215
      • Investigational Site 8
  • Texas
    • Austin, Texas, United States, 78759
      • Investigational Site 9
  • Virginia
    • Arlington, Virginia, United States, 22209
      • Investigational site 10
  • Washington
    • Seattle, Washington, United States, 98109
      • Investigational site 11

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.
• Dissatisfaction with the abdominal fat expressed by the participant using Patient Self Rating Scale (PSRS) reported by participant.
• 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.

Exclusion Criteria:

• 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 any uncontrolled cardiovascular disease or has any clinically significant abnormal finding in ECG at Screening.
• 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.
• Participant with liver cirrhosis or abnormal liver function, or with any hepatic condition that interferes with the safety or efficacy assessments.
• Participant with any renal impairment.
• Participant has received any investigational product.
• Participant considered to be unreliable or incapable of complying with the requirements of the protocol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CBL-514 injection; Participants will receive CBL-514 administered up to 120 mL per treatment at a 4-weeks interval for up to 4 treatments.	Drug: CBL-514 Injection; Provided as a ready for use injectable CBL-514 solution
Placebo Comparator: Injectable 0.9% Sodium Chloride solution; Participants will receive 0.9% Sodium Chloride administered up to 120 mL per treatment at a 4-week interval for up to 4 treatments.	Drug: 0.9% Sodium Chloride; Injectable 0.9% Sodium Chloride solution as placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants achieving at least a 2-grade improvement from baseline on Patient Reported-Abdominal Fat Rating Scale (PR-AFRS) and a clinically meaningful reduction in abdominal fat.	Measured by a 5-point ordinal scale and MRI	From baseline to 4 weeks after final treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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.	Measured by 5-point ordinal scales	From baseline to 4 weeks after final treatment

Collaborators and Investigators

• Sponsor: Caliway Biopharmaceuticals Co., Ltd.
• Investigators: Study Director: Anne Sheu, Caliway Biopharmaceuticals Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: April 8, 2026
• First Submitted That Met QC Criteria: April 8, 2026
• First Posted (Actual): April 14, 2026

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Inorganic Chemicals; Chlorine Compounds; Sodium Compounds; Chlorides; Hydrochloric Acid; Sodium Chloride
• Other Study ID Numbers: CBL-0302

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No