Subcutaneous Fat
Conditions
Brief 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)
Detailed 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.
Interventions
Provided as a ready for use injectable CBL-514 solution
Injectable 0.9% Sodium Chloride solution as placebo
Sponsors
Caliway Biopharmaceuticals Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Participants remain in their blinded parent-study cohorts to allow for unbiased long-term safety monitoring. No investigational product is administered during Stage 1.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 taking prescription or over the counter (OTC) weight reduction medication or is in a weight reduction program. 3. Participant has an unstable condition or is otherwise thought to be unreliable or incapable of complying with the requirements of the protocol. 4. 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 committed to using condoms consistently throughout the study. Ova and sperm donation are to occur after a certain washout period post IP treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of participants with at least 1 TEAE | 6,9, and 12 months after last treatment of parent studies |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants with at least 1 AESI | 6,9, and 12 months after last treatment of parent studies | — |
| Percentage of participants who maintain 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) | From baseline to 6,9, and 12 months after last treatment in parent studies | Measured by 5-point ordinal scales from Grade 1 to Grade 5 for assessing the severity of abdominal fat. The higher the grade, the more the abdominal fat. |
| Percentage change from baseline in abdominal fat | From baseline to 6,9, and 12 months after last treatment in parent studies | Measured by MRI |
Countries
United States
Contacts
CONTACTNT Tan
STUDY_DIRECTORAnne Sheu
Caliway Biopharmaceuticals Co., Ltd.
Outcome results
None listed