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Идёт набор NCT07220772

A Study Evaluating Mibavademab Treatment of Obesity Due to Leptin (LEP) Gene Mutations in Children, Adolescents and Adults

Фаза III С лечением Monogenic Obesity

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Mibavademab.
Кому может быть актуально
Состояния в реестре: Monogenic Obesity. Базовые параметры: от 2 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Германия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

An Open-Label Study of Mibavademab (REGN4461), a Leptin Receptor Agonist, for the Treatment of Monogenic Obesity Due to Biallelic Loss of Function Variants of the LEP Gene

Обзор

This study is researching an experimental drug called mibavademab. The study is focused on patients with a condition called monogenic obesity. Monogenic obesity is caused by a change in the leptin gene that keeps it from working properly. This causes the body to not be able to feel full or control feelings of hunger. The aim of the study is to see how well mibavademab controls the body weight and how safe it is. The study is looking at several other research questions, including: * How much mibavademab is in the blood at different times * Whether the body makes proteins called antibodies against mibavademab (which could stop mibavademab from working as well or could lead to side effects) * What side effects may happen from taking mibavademab

Вмешательства

  • Препарат Mibavademab
    Administered as per the protocol

Первичные конечные точки

  • Percent change in Body Mass Index (BMI) [Срок оценки: Baseline to Week 24]
Вторичные конечные точки (12)
  • Percent change in BMI [Срок оценки: Baseline to Week 52]
  • Absolute change in BMI [Срок оценки: Baseline, Through Week 52]
  • Percent change in body weight [Срок оценки: Baseline, Through Week 52]
  • Absolute change in body weight [Срок оценки: Baseline, Through Week 52]
  • Change in waist circumference [Срок оценки: Baseline, Through Week 52]
  • Change in absolute total fat mass by whole body DXA [Срок оценки: Baseline, Through Week 52]
  • Change in percent total fat mass by whole body DXA [Срок оценки: Baseline, Through Week 52]
  • Change in absolute regional fat mass by whole body DXA [Срок оценки: Baseline, Through Week 52]
  • Change in percent regional fat mass by whole body DXA [Срок оценки: Baseline, Through Week 52]
  • Change in scores in the symptoms of hyperphagia questionnaire [Срок оценки: Baseline, Through Week 52]
  • Change in scores in the impacts of hyperphagia questionnaire [Срок оценки: Baseline, Through Week 52]
  • Change in scores in the hunger questionnaire [Срок оценки: Baseline, Through Week 52]

Критерии участия

Критерии включения

  • Has documented medical history of biallelic loss of function variants of the LEP gene prior to the screening visit
  • Has class ≥2 obesity at screening and at baseline, as defined in the protocol

Критерии исключения

  • Unwilling or unable to provide, or have the treating physician provide, documented historical weight for at least 6 months prior to screening
  • History of bariatric surgery within approximately the past 12 months of study screening
  • History of weight loss of ≥5% of body weight in approximately the past 3 months of study screening
  • History of genetic causes of obesity other than/in addition to biallelic loss of function variants of the LEP gene
  • History of schizophrenia, bipolar disorder, or other mental illness that, in the opinion of the investigator, might pose a safety risk to participation in a clinical study of an investigational drug
  • Any suicidal ideation of type 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS) during screening or baseline, or any lifetime history of a suicide attempt, or any lifetime history of suicidal behavior, including ideation
  • Treatment with medications for weight loss or medications with known side effects of weight loss within the past approximately 3 months of study screening
  • Participants currently being treated with metreleptin, or a history of prior treatment with metreleptin as defined in the protocol

NOTE: Other Protocol-defined Inclusion/Exclusion Criteria Apply

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Германия · 1 центр
  • ULM University Medical Centre — Ulm

Идентификаторы

NCT: NCT07220772 · R4461-MOB-2471 · 2024-518674-14-00

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗