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RESCUE: Discontinuation of GLP-1 150 生活習慣

募集中
治験（臨床試験）の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします！「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT07190794 は 観察研究 臨床試験 で、肥満 に関するものです。現在は 募集中 で、2025年12月17日 から開始しています。150 名の参加者 の募集が計画されています。この試験は ボストン・サイエンティフィック によって主導され、2026年6月1日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2026年3月19日 です。
概要
This study is designed to compare weight loss outcomes and safety of ESG versus lifestyle modification in patients with obesity who discontinued GLP-1 therapy due to intolerance or suboptimal weight loss.
詳細説明
This retrospective cohort study includes collection of data from medical records for consecutively treated patients undergoing treatment for weight loss following GLP-1 discontinuation. Weight loss treatment is either ESG with OverStitch™ OverStitch NXT™ or matched timeframe controls who participated in a lifestyle modification program for weight loss management.

Subjects will be enrolled in a 2:1 ratio (ESG: Lifest...

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公式タイトル

Evaluation of Endoscopic Sleeve Gastroplasty (ESG) as an Alternative Weight Loss Strategy for Patients With Obesity Discontinuing GLP-1 Receptor Agonists Due to Intolerance or Ineffectiveness: A Retrospective Study

疾患名
肥満
その他の研究識別子
  • E7234
NCT番号
NCT07190794
開始日
2025-12-17
最終更新日
2026-03-19
終了予定日
2026-06
目標参加者数
150
試験の種類
観察研究
状況
募集中
キーワード
GLP-1
ESG
OverStitch
群（アーム）／介入
参加グループ/群介入/治療法
ESG Recipients
After discontinuing GLP-1 medication, this group elected to have an ESG procedure as a weight loss treatment.
OverStitch™ or OverStitch NXT™
The OverStitch™ or OverStitch NXT™ Endoscopic Suturing System was used as part of each patient's ESG procedure within the routine clinical practice.
Lifestyle Modification
After discontinuing GLP-1 medication, this group elected to participate in a structured lifestyle modification program.
生活習慣の修正
Patients participated in a lifestyle modification program for weight loss management.
主要評価項目
評価指標指標の説明時間枠
Percent total body weight loss (TBWL) at 1 year from baseline
The study will measure the percentage of total body weight loss for a period of one year from baseline.
12 months
副次評価項目
評価指標指標の説明時間枠
Change in body mass index (BMI)
The study will measure change in BMI for a period of one year from baseline.
12 months
Percentage of excess weight loss
The study will measure the percentage of excess weight loss for a period of one year from baseline.
12 months
Percentage of patients that achieved 5%, 10% and 15% total body weight loss
The study will measure the percentage of patients that achieved 5%, 10% and 15% total body weight loss in the one year from baseline.
12 months
Metabolic markers, if available
Metabolic markers include changes from baseline in the following items: 1. HbA1c 2. Fasting blood glucose 3. Total cholesterol 4. LDL 5. HDL 6. Triglycerides 7. Blood pressure (systolic and diastolic blood pressure)
12 months
Visit compliance and impact to responder rate
Responders are defined as \>= 10% TBWL. This analysis will analyze if responder rate improves with higher visit compliance (number of completed interactions with a provider for weight loss management).
12 months
Rate of procedure-related serious adverse events within 1-year post-ESG
The study will examine the rate of procedure-related serious adverse events within 1-year post-ESG.
12 months
参加アシスタント
適格基準

対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
  1. Adults (≥ 18 years)
  2. BMI ≥30 kg/m² and ≤ 50 kg/m2
  3. Discontinued GLP-1 therapy for weight loss (semaglutide and tirzepatide only) for intolerance or suboptimal weight loss (<5% TBWL after 3 months at maximally tolerated dose)
  4. Initiation of weight loss management no earlier than August 2021
  5. Completed 1-year follow-up for weight loss management (ESG and lifestyle modification or lifestyle modification alone) following initiation of weight loss treatment
  6. Completed at least two interim visits for weight loss management from 1, 3, 6, through 9 months following initiation of weight loss treatment

  1. Missing data regarding GLP-1 treatment history, including weight before GLP-1 treatment and at discontinuation, and discontinuation reason
  2. History of GLP-1 medication for a reason other than weight management
  3. Had bariatric surgery or an endoscopic procedure for weight loss treatment other than ESG with OverStitch™ or OverStitch NXT™ within 1 year of starting weight loss management
  4. Had an additional endoscopic treatment performed prior to or at the time of the ESG procedure that could influence weight loss results
  5. Had another weight loss treatment during the 1-year follow-up reported during this study. Weight loss treatment includes but is not limited to appetite suppressants, anti-obesity medications, plastic surgery or body contouring procedures.
  6. Pregnancy during the 1 year following initiation of weight loss management
Boston Scientific Corporation logoボストン・サイエンティフィック136 件のアクティブな治験を探索
試験中央連絡先
連絡先: Katherine Stroud, 617-233-5845, [email protected]
連絡先: Pooja Goswamy, 508-683-4335, [email protected]
3 1カ国の場所

Florida

Bariendo, Miami, Florida, 33179, United States
Pichamol Jirapinyo, MD, MPH, 連絡先, 305-921-4219, [email protected]
募集中

Massachusetts

Brigham & Women's Hospital, Boston, Massachusetts, 02115, United States
Michele Ryan, 連絡先, 617-732-5500, [email protected]
募集準備中

West Virginia

West Virginia University, Morgantown, West Virginia, 26506, United States
Zim Warda Hasan, 連絡先, 364-203-1900, [email protected]
募集準備中