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.
Caliway Biopharmaceuticals Co., Ltd.
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.
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
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…
Interventions
- DrugCBL-514 Injection
Provided as a ready for use injectable CBL-514 solution
- Other0.9% Sodium Chloride
Injectable 0.9% Sodium Chloride solution as placebo
Locations (13)
- Investigational site 1Encinitas, California
- Investigational site 2West Palm Beach, Florida
- Investigational site 3Chicago, Illinois
- Investigational site 4Baton Rouge, Louisiana
- Investigational site 5Hunt Valley, Maryland
- Investigational site 6Omaha, Nebraska