Меню
Идёт набор NCT07092618

Effectiveness of Alternative Therapies in Maintaining Weight Loss Achieved by GLP-1 Medications Post-Cessation

Фаза II / Фаза III С лечением Longevity GLP-1 Geroscience Aging

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: Metformin, Rapamycin, Naltrexone, Vitamin C.
Кому может быть актуально
Состояния в реестре: Longevity, GLP-1, Geroscience, Aging. Базовые параметры: 40 лет — 85 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
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Effectiveness of Alternative Therapies in Maintaining Weight Loss Achieved by GLP-1 Medications Post-Cessation: A Randomized, Controlled Trial

Обзор

The goal of this randomized, controlled trial is to evaluate the effectiveness of alternative therapies (metformin alone, with rapamycin, and with low-dose naltrexone) in maintaining weight loss in patients weaning off GLP-1 medications. The main questions it aims to answer are: * Whether the combination of metformin, with or without rapamycin or low-dose naltrexone, will be adequate to maintain the relative weight of individuals gradually discontinuing GLP-1 receptor agonist use. * Whether individuals discontinuing GLP-1 receptor agonist use who instead use a combination of metformin, with or without rapamycin or low-dose naltrexone, will experience less weight regain over the course of six months post-cessation than those who do not use any alternative medications. Researchers will compare the four groups: 1) control, 2) metformin, 3) metformin + rapamycin, and 4) metformin + low-dose naltrexone, to assess changes in the percentage of weight regain, metabolic indicators (e.g., HbA1c, lipid profile), and quality of life PROs, six months after cessation of GLP-1 therapy. Participants will: * Administer the assigned intervention following a dosing and administration protocol provided by the study and medical team. * Complete a medical intake for overall health status, medical history and demographic information, * Complete patient-reported outcomes/surveys and assessments * Complete blood work at baseline and every 16 weeks thereafter to measure CBC, CMP, and standard health biomarker panels (e.g., cholesterol, glucose, creatinine, sodium, potassium). * Share data from health wearables with the research team throughout the study to improve the accuracy of evaluating activity, sleep, heart rate, and other related healthspan measures.

Вмешательства

  • Препарат Metformin
    Increasing doses from 500mg/d to 2000mg/d metformin
  • Препарат Rapamycin
    Increasing doses from 1mg/wk to 6mg/wk rapamycin
  • Препарат Naltrexone
    Increasing doses from 1.5mg b.i.d. to 4.5mg b.i.d. low-dose naltrexone
  • Пищевая добавка Vitamin C
    Placebo control - increasing doses from 250mg/d to 1000mg/d vitamin C (ascorbic acid)

Первичные конечные точки

  • Evaluate the effectiveness of metformin in maintaining GLP1-induced weight loss in participants weaning off of Ozempic or Wegovy (or compounded semaglutide equivalent) [Срок оценки: 6 months]
  • Evaluate the effectiveness of metformin + rapamycin in maintaining GLP1-induced weight loss in participants weaning off of Ozempic (or equivalent) or Wegovy (or equivalent) [Срок оценки: 6 months]
  • Evaluate the effectiveness of metformin + LDN in maintaining GLP1-induced weight loss in participants weaning off of Ozempic (or equivalent) or Wegovy (or equivalent) [Срок оценки: 6 months]
Вторичные конечные точки (12)
  • Evaluate the effectiveness of metformin on perceived metabolic health status in participants weaning off of Ozempic or Wegovy (or compounded semaglutide equivalent) [Срок оценки: 6 months]
  • Evaluate the effectiveness of metformin on biological metabolic health in participants weaning off of Ozempic or Wegovy (or compounded semaglutide equivalent) [Срок оценки: 6 months]
  • Evaluate the effectiveness of metformin + rapamycin on perceived metabolic health status in participants weaning off of Ozempic or Wegovy (or compounded semaglutide equivalent) [Срок оценки: 6 months]
  • Evaluate the effectiveness of metformin + rapamycin on biological metabolic health in participants weaning off of Ozempic or Wegovy (or compounded semaglutide equivalent) [Срок оценки: 6 months]
  • Evaluate the effectiveness of metformin + LDN on perceived metabolic health status in participants weaning off of Ozempic or Wegovy (or compounded semaglutide equivalent) [Срок оценки: 6 months]
  • Evaluate the effectiveness of metformin + LDN on biological metabolic health in participants weaning off of Ozempic or Wegovy (or compounded semaglutide equivalent) [Срок оценки: 6 months]
  • Evaluate the effectiveness of metformin on mood-related quality of life in participants weaning off of Ozempic (or equivalent) or Wegovy (or equivalent) [Срок оценки: 6 months]
  • Evaluate the effectiveness of metformin on physical health-related quality of life in participants weaning off of Ozempic (or equivalent) or Wegovy (or equivalent) [Срок оценки: 6 months]
  • Evaluate the effectiveness of metformin + rapamycin on mood-related quality of life in participants weaning off of Ozempic (or equivalent) or Wegovy (or equivalent) [Срок оценки: 6 months]
  • Evaluate the effectiveness of metformin + rapamycin on physical health-related quality of life in participants weaning off of Ozempic (or equivalent) or Wegovy (or equivalent) [Срок оценки: 6 months]
  • Evaluate the effectiveness of metformin + LDN on mood-related quality of life in participants weaning off of Ozempic (or equivalent) or Wegovy (or equivalent) [Срок оценки: 6 months]
  • Evaluate the effectiveness of metformin + LDN on physical health-related quality of life in participants weaning off of Ozempic (or equivalent) or Wegovy (or equivalent) [Срок оценки: 6 months]

Критерии участия

Критерии включения

  • Existing AgelessRx patient
  • Adults (40 - 85 years of age)
  • Any sex
  • Any ethnicity
  • BMI ≥ 22 kg/m\^2
  • Have been on GLP-1s (Wegovy, Ozempic, or a compounded form of GLP-1s) for at least three months before study initiation
  • Have lost at least 15 lbs during their GLP-1 use

Критерии исключения

  • Individuals who are denied a longevity product by the AgelessRx medical team will not be asked to participate in any product specific test(s) or questionnaire(s)
  • History of bariatric surgery
  • Use of weight-loss medications other than GLP-1s within the past 6 months
  • Age <40 years
  • Contraindications to naltrexone, metformin, or rapamycin
  • Significant psychiatric illness that may affect participation
  • Pregnant or breastfeeding individuals

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
Открытое
Основная цель
Профилактика

Центры проведения

США · 1 центр
  • AgelessRx — Chicago

Идентификаторы

NCT: NCT07092618 · ALRx009

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗