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

A total of approximately 250 adult participants with Grade 3 or Grade 4 abdominal fat, as assessed by Clinician Reported-Abdominal Fat Rating Scale (CR-AFRS) and Patient Reported-Abdominal Fat Rating Scale (PR-AFRS) at baseline will be enrolled. Each participant will receive up to 4 treatments of allocated study drug administered subcutaneously to the abdomen, once every 3 weeks.

• CBL-514 Injection (Drug): Provided as a ready for use injectable CBL-514 solution
• 0.9% Sodium Chloride (Drug): Injectable 0.9% Sodium Chloride solution as placebo

Primary outcomes

• Percentage change from Baseline in abdominal fat in the CBL-514 group versus the placebo group [From baseline to 4 weeks after final treatment]: Measured by MRI

Secondary outcomes

• Percentage change from Baseline in abdominal fat in the CBL-514 group versus the placebo group [From baseline to 12 weeks after final treatment]: Measured by MRI
• 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]: Measured by a 5-point rating scale from Grade 1 to Grade 5 for assessing the severity of abdominal fat. Lower score indicates less abdominal fat. Higher score indicates more abdominal fat.
• 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]: Measured by a 5-point rating scale from Grade 1 to Grade 5 for assessing the severity of abdominal fat. Lower score indicates less abdominal fat. Higher score indicates more abdominal fat.

Sex: All, ages: 18 Years to any, accepts healthy volunteers

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* Participant with liver cirrhosis or abnormal liver function test at Screening
* Participant currently on dialysis or with any renal impairment at Screening
* Participant has received any investigational product (including a device) within 3 months before Screening.
* Participant has an unstable condition (eg, psychiatric disorder, history of substance abuse within 3 years before Screening) or is otherwise thought to be unreliable or incapable of complying with the requirements of the protocol (eg, visit schedule, off-site MRI measurement).
* Participant with a known history or current diagnosis of body dysmorphic disorder or eating disorders.
* Participant has a history of vasovagal syncope.

• Anne Sheu, Study director, Caliway Biopharmaceuticals Co., Ltd.