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 320 adult participants with moderate or severe abdominal fat at Baseline will be enrolled. Each participant will receive up to 4 treatments of allocated study drug administered subcutaneously to the abdomen, once every 4 weeks.
Eligibility Criteria
Age Range: 18 years to No maximum
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. Dissatisfaction with the abdominal fat reported by participant as 'Extremely Dissatisfied', 'Dissatisfied', or 'Slightly dissatisfied'.
5. Participant maintained a stable lifestyle.
6. 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 willing to commit to using condom consistently and refraining from sperm donation.
2. Participant who has coagulation disorders.
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 risk factors for torsade de pointes, currently has any uncontrolled cardiovascular disease, or any clinically significant finding on baseline ECG.
6. Participant has a history of peripheral arterial disease or clinically significant venous disease involving the lower extremities.
7. 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.
8. Participant has a visible Panniculus on the abdomen in standing position.
9. Participant has severe abdominal visceral fat.
10. Participant has skin conditions, which would pose risk to the participant if receiving the IP or interfere with the safety or efficacy evaluation.
11. Participant has undergone the procedures at the treatment area that may affect IP administration.
12. Participant with contraindications to MRI imaging.
13. Participant is on prescription or over-the-counter weight reduction medication, weight reduction programs, or taking oral or injectable GLP-1 agonists.
14. Participant is undergoing long-term systemic steroid or immunosuppressive therapy.
15. Participant is taking or will take any medication that is known strong inhibitor, inducer or is a sensitative substrate for CYP enzymes, or medication with narrow therapeutic index.
16. Participant with a history of hypersensitivity to local anesthesia.
17. Participant with known allergies or significant adverse reaction to the IP.
18. Participant with liver cirrhosis or abnormal liver function, or with any hepatic condition that interferes with the safety or efficacy assessments.
19. Participant with any renal impairment.
20. Participant has received any investigational product within 3 months.
21. Participant considered to be unreliable or incapable of complying with the requirements of the protocol.