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 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.
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. 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 contra…
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