Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide (MARITIME-2-EXTENSION)

Официальное название

A Phase 3, Randomized, Double-Blind Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Participants With Obesity or Overweight With Type 2 Diabetes Mellitus

Обзор

The primary objective of this trial is to evaluate the long-term efficacy, safety, and tolerability of maridebart cafraglutide in participants with obesity and type 2 diabetes mellitus. Trial 20210182 is extension of trial 20210184 (NCT06858878).

Вмешательства

• Препарат Maridebart Cafraglutide
  Administered subcutaneously.
• Препарат Placebo
  Administered subcutaneously.

Первичные конечные точки

• Percent Change in Body Weight from Baseline of the Parent Trial (20210184) [Срок оценки: Baseline of parent trial (20210184) to Week 48 of current trial]
• Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [Срок оценки: Baseline of current trial up to 60 weeks]

Вторичные конечные точки (12)

• Percentage of Participants Achieving ≥ 5% Reduction in Body Weight from Baseline of the Parent Trial [Срок оценки: Baseline of parent trial to Week 48 of current trial]
• Percentage of Participants Achieving ≥ 10% Reduction in Body Weight from Baseline of the Parent Trial [Срок оценки: Baseline of parent trial to Week 48 of current trial]
• Percentage of Participants Achieving ≥ 15% Reduction in Body Weight from Baseline of the Parent Trial [Срок оценки: Baseline of parent trial to Week 48 of current trial]
• Percentage of Participants Achieving ≥ 20% Reduction in Body Weight from Baseline of the Parent Trial [Срок оценки: Baseline of parent trial to Week 48 of current trial]
• Change from Baseline of the Parent Trial in Hemoglobin A1c [Срок оценки: Baseline of parent trial to Week 48 of current trial]
• Change from Baseline of the Parent Trial in Waist Circumference [Срок оценки: Baseline of parent trial to Week 48 of current trial]
• Change from Baseline of the Parent Trial in the Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score [Срок оценки: Baseline of parent trial to Week 48 of current trial]
• Percent Change from Baseline in Body Weight [Срок оценки: Baseline of current trial to Week 48]
• Percentage of Participants with No Body Weight Gain of >3% From Baseline [Срок оценки: Week 48 of current trial]
• Percentage of Participants with No Body Weight Gain of >5% From Baseline [Срок оценки: Week 48 of current trial]
• Percentage of Body Weight Reduction Maintained from the Parent Trial [Срок оценки: Baseline of parent trial to Week 48 of current trial]
• Percentage of Participants Maintaining ≥ 80% of the Body Weight Reduction Achieved in the Parent Trial [Срок оценки: Baseline of parent trial to Week 48 of current trial]

Критерии участия

Критерии включения

• Signed informed consent form (ICF) indicating compliance with the requirements and restrictions listed in the ICF and this protocol.
• Participants completing Study 20210184 must meet the following criteria:

• Completed the Week 72 visit in Study 20210184.
• Did not permanently discontinue the investigational product in the parent trial (20210184).
• Randomized within 7 days of week 72 visit in the parent trial.
• Participants must use protocol-specified contraception during treatment and for 16 weeks after the last dose of trial intervention.

Критерии исключения

• Planned (during the trial) surgical, endoscopic, or device-based treatment for obesity.
• Body mass index (BMI) ≤ 18.5 kilograms per meter square (kg/m\^2).
• Participant has known sensitivity to any of the products or components to be administered during dosing.
• History of ischemic optic neuropathy.
• Any malignancy diagnosed during the parent trial, except for the following treated with curative intent:

• Nonmelanoma skin cancers
• Breast ductal carcinoma in situ
• Cervical carcinoma in situ
• Prostate cancer in situ
• Newly identified (during the parent trial) multiple endocrine neoplasia syndrome type 2, or family history (first-degree relative\[s\]) history of medullary thyroid carcinoma (MTC).
• Patient Health Questionnaire-9 (PHQ-9) score ≥ 15 at the Week 72 visit from the parent trial (20210184) before randomization.
• Any suicidal ideation (category 4 or 5) or any suicidal behavior on the Columbia-Suicide Severity Rating Scale (C-SSRS), Since Last Visit version, at the Week 72 visit from the parent trial before randomization.
• Participant unlikely to be able to complete all protocol-required procedures, restrictions and requirements, in the judgment of the individual and investigator.
• History or evidence of any other clinically significant disorder, condition, disease (including, but not limited to known drug or alcohol abuse, eating disorders, and conditions identified during the parent trial) that, in the opinion of the investigator, would pose a risk to participant safety.
• Currently pregnant (confirmed with positive pregnancy test) or breastfeeding or planning to become pregnant or breastfeed while on trial until an additional 16 weeks after the last dose of trial intervention.
• Major surgical procedures planned during the trial.
• Participants with minor surgical procedures (not requiring general anesthesia or deep sedation) planned during the trial may be eligible at the discretion of the investigator.
• Investigative site personnel directly affiliated with the trial and/or their immediate family (ie, spouse, parent, child, or sibling, whether biological or legally adopted).

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07684144 · 20210182 · 2025-524788-19-00 · U1111-1332-0531

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗