A Phase 3b, Multicenter, Two Stage, Double-blind, Long Term Follow up and Open Label Extension Study of Participants Who Have Completed the CBL-0301 or CBL-0302 Study for Reducing Abdominal Subcutaneous Fat (Stage 1)
Caliway Biopharmaceuticals Co., Ltd.
Summary
A Phase 3b, Multicenter, Two stage, Double-blind, Long term Follow up and Open-label Extension Study of Participants Who have Completed the CBL-0301 or CBL-0302 Study for Reducing Abdominal Subcutaneous Fat (Stage 1)
Description
A total of approximately 300 adult participants that has received at least one study drug treatment and completed one follow-up visit in the parent studies will be enrolled. Each participant will undergo three follow-up visits, scheduled every three months in Stage 1.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Participant must have received at least 1 treatment of CBL 514 or Placebo and completed the FU1 visit of the parent study. 2. Participant is willing to maintain a stable lifestyle. 3. Participant voluntarily signs the Informed Consent Form (ICF) for Stage 1 and, in the opinion of the Investigator or delegate, is physically and mentally capable of participating in the study, and willing to adhere to the study procedures. Exclusion Criteria: 1. Participant has had or will be undergoing treatment that may affect the evaluation of the treated area. 2. Participant is takin…
Interventions
- DrugCBL-514 Injection
Provided as a ready for use injectable CBL-514 solution
- Drug0.9 % sodium chloride
Injectable 0.9% Sodium Chloride solution as placebo
Location
- Investigational site 1Encinitas, California