Menu
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)

Phase III Interventional Subcutaneous Fat

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CBL-514 Injection, 0.9 % sodium chloride.
Who it may be relevant to
Registry conditions: Subcutaneous Fat. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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)

Overview

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

  • Drug CBL-514 Injection
    Provided as a ready for use injectable CBL-514 solution
  • Drug 0.9 % sodium chloride
    Injectable 0.9% Sodium Chloride solution as placebo

Primary outcome measures

  • Percentage of participants with at least 1 TEAE [Time frame: 6,9, and 12 months after last treatment of parent studies]
Secondary outcome measures (3)
  • Percentage of participants with at least 1 AESI [Time frame: 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) [Time frame: From baseline to 6,9, and 12 months after last treatment in parent studies]
  • Percentage change from baseline in abdominal fat [Time frame: From baseline to 6,9, and 12 months after last treatment in parent studies]

Eligibility criteria

Inclusion criteria

  • Participant must have received at least 1 treatment of CBL 514 or Placebo and completed the FU1 visit of the parent study.
  • Participant is willing to maintain a stable lifestyle.
  • 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

  • Participant has had or will be undergoing treatment that may affect the evaluation of the treated area.
  • Participant is taking prescription or over the counter (OTC) weight reduction medication or is in a weight reduction program.
  • Participant has an unstable condition or is otherwise thought to be unreliable or incapable of complying with the requirements of the protocol.
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Investigational site 1 — Encinitas

Identifiers

NCT: NCT07733947 · CBL-0303 (Stage 1)

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗