A Study to Evaluate the Efficacy and Safety of CBL-514 Injection for Reducing Subcutaneous Fat (SUPREME-01)

Caliway Biopharmaceuticals

Status and phase: Not yet enrolling; Phase 3

Conditions: Subcutaneous Fat

Treatments: Other: 0.9% Sodium Chloride; Drug: CBL-514 Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT07140939

CBL-0301

Details and patient eligibility

About

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.

Full description

A total of approximately 300 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 3 weeks.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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. Participant maintained a stable lifestyle.
5. 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 committing to using condom consistently and refraining from sperm donation.
2. Participant who has impeded coagulation or platelet aggregation.
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 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.
6. Participant has a visible Panniculus on the abdomen in standing position.
7. Participant has severe abdominal visceral fat.
8. Participant has skin conditions, which would pose risk to the participant if receiving the IP or interfere with the safety or efficacy evaluation.
9. Participant has undergone the procedures at the treatment area that may affect IP administration.
10. Participant with contraindications to MRI imaging.
11. Participant is on prescription or over-the-counter weight reduction medication, weight reduction programs, or taking oral or injectable GLP-1 agonists.
12. Participant is undergoing long-term systemic steroid or immunosuppressive therapy which may affect the treatment area.
13. 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.
14. Participant with history of hypersensitivity to local anesthesia.
15. Participant with known allergies or significant adverse reaction to the IP.
16. Participant with liver cirrhosis or abnormal liver function, or with any hepatic condition that interferes with the safety or efficacy assessments.
17. Participant with any renal impairment.
18. Participant has received any investigational product.
19. Participant considered to be unreliable or incapable of complying with the requirements of the protocol.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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300 participants in 2 patient groups, including a placebo group

CBL-514 injection

Experimental group

Description:

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.

Treatment:

Drug: CBL-514 Injection

Injectable 0.9% Sodium Chloride solution

Placebo Comparator group

Description:

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.

Treatment:

Other: 0.9% Sodium Chloride