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

Официальное название

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)

Обзор

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)

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Percentage of participants with at least 1 TEAE [Срок оценки: 6,9, and 12 months after last treatment of parent studies]

Вторичные конечные точки (3)

• Percentage of participants with at least 1 AESI [Срок оценки: 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) [Срок оценки: From baseline to 6,9, and 12 months after last treatment in parent studies]
• Percentage change from baseline in abdominal fat [Срок оценки: From baseline to 6,9, and 12 months after last treatment in parent studies]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Investigational site 1 — Encinitas

Идентификаторы

NCT: NCT07733947 · CBL-0303 (Stage 1)

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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