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Not Yet Recruiting NCT07733947

A Study to Evaluate the Maintenance of Efficacy and Long-term Safety of CBL-514 Injection for Reducing Subcutaneous Fat (Stage 1)

Conditions: Subcutaneous Fat

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 300
Sponsor: Caliway Biopharmaceuticals Co., Ltd.

Location: Investigational site 1 Encinitas California

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)

Eligibility Criteria

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07733947). StuddyBuddy aggregates publicly available trial information.