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

Official title

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.

Overview

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 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.

Interventions

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

Primary outcome measures

• 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. [Time frame: From baseline to 4 weeks after final treatment]

Secondary outcome measures (2)

• Percentage change from baseline in abdominal fat in the CBL-514 group versus the placebo group. [Time frame: 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. [Time frame: From baseline to 4 weeks after final treatment]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

United States · 11 centers

• Investigational Site 1 — Encinitas
• Investigational site 2 — Aventura
• Investigational Site 3 — Alpharetta
• Investigational Site 4 — Hunt Valley
• Investigational site 5 — Omaha
• Investigational site 6 — New York
• Investigational Site 7 — Canal Winchester
• Investigational site 8 — Nashville
• … and 3 more centers

Canada · 2 centers

• Investigational Site 13 — Vancouver
• Investigational Site 14 — Woodbridge

Australia · 1 center

• Investigational site 12 — Melbourne

Identifiers

NCT: NCT07526974 · CBL-0302

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗