Caliway Biopharmaceuticals Co., Ltd.
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 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.
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 proc…
Provided as a ready for use injectable CBL-514 solution
Injectable 0.9% Sodium Chloride solution as placebo