Effectiveness and Safety of Tirzepatide Among Participants With Obesity With or Without Type 2 Diabetes Mellitus (T2DM)

Официальное название

A Study of Real-World Effectiveness and Safety of Tirzepatide Among Participants With Obesity With or Without Type 2 Diabetes Mellitus (T2DM) in Bangladesh

Обзор

This is a prospective, multicenter, real-world study conducted in Bangladesh to assess the effectiveness and safety of Tirzepatide compared to structured lifestyle interventions, including dietary modifications and exercise, in obese adults with or without Type 2 Diabetes Mellitus (T2DM). The study aims to determine whether treatment with Tirzepatide results in superior weight reduction outcomes compared to lifestyle-based approaches. Adult participants (≥18 years) with a body mass index (BMI) ≥25 kg/m² and no prior exposure to GLP-1 receptor agonists will be enrolled at the discretion of the treating physician. Eligible participants will receive either once-weekly Tirzepatide or participate in lifestyle intervention programs aligned with standard clinical care.

Вмешательства

• Препарат Tirzepatide
  Exposure
• Поведенческое Life Style Modification
  Referent group - Lifestyle interventions, exercise, and diet control

Первичные конечные точки

• Percentage change in body weight at Week 24 in both treatment groups. [Срок оценки: Baseline to 24 Weeks]
• Percentage of participants withdrawn from the study due to adverse events by Week 24 [Срок оценки: Up to Week 24]

Вторичные конечные точки (9)

• Absolute change in body weight at Week 24 across both treatment groups [Срок оценки: Baseline to 24 weeks]
• Change from baseline in Body Mass Index (BMI) and waist circumference at Week 24 across both treatment groups [Срок оценки: Baseline to Week 24]
• Percentage of participants achieving ≥15% reduction in body weight from baseline to Week 24 [Срок оценки: Baseline to Week 24]
• Percent change from baseline in Hemoglobin A1c (HbA1c) at Week 24 [Срок оценки: Baseline to Week 24]
• Percentage of diabetic participants achieving HbA1c <7% at Week 24 [Срок оценки: Week 24]
• Percentage of participants achieving the highest dose of Tirzepatide by Week 24 [Срок оценки: Up to Week 24]
• Frequency of adverse events (AEs) and serious adverse events (SAEs) reported by Week 24 [Срок оценки: Up to Week 24]
• Number of hypoglycemic events reported by Week 24 [Срок оценки: Up to Week 24]
• Number of self-reported gastrointestinal (GI) adverse events by Week 24 [Срок оценки: Up to Week 24]

Критерии участия

Критерии включения

• Adult patients of both sexes, aged ≥18 years.
• Body mass index (BMI) ≥25 kg/m².
• Naïve to glucagon-like peptide-1 receptor agonist (GLP-1 RA) therapy.
• Self-reported stable body weight (change ≤5 kg) over the past 3 months.

Критерии исключения

• Diagnosis of diabetes other than Type 2 Diabetes Mellitus.
• History of chronic or acute pancreatitis.
• Presence of acute medical conditions, including acute hepatitis, myocardial infarction, stroke, heart failure, febrile illness, or acute diarrheal disease.
• Evidence of significant, uncontrolled endocrine disorders (e.g., Cushing's syndrome, thyroid disorders, adrenal insufficiency, congenital adrenal hyperplasia).
• History or presence of malignancy.
• Active gallbladder disease.
• Female participants who are pregnant, breastfeeding, planning pregnancy, or of childbearing potential, not using adequate contraceptive methods.
• Prior or planned surgical treatment for obesity.
• Use of weight-loss products (including prescription medications, over-the-counter drugs, or herbal preparations) within 3 months prior to screening.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Bangladesh · 3 центра

• Trauma Centre, Cumilla. — Comilla
• Dhaka Medical College Hospital, Dhaka — Dhaka
• Rajshahi Medical College Hospital, Rajshahi — Rajshahi

Публикации

• Ruze R, Liu T, Zou X, Song J, Chen Y, Xu R, Yin X, Xu Q. Obesity and type 2 diabetes mellitus: connections in epidemiology, pathogenesis, and treatments. Front Endocrinol (Lausanne). 2023 Apr 21;14:1161521. doi: 10.3389/fendo.2023.1161521. eCollection 2023. PMID 37152942
• Forzano I, Varzideh F, Avvisato R, Jankauskas SS, Mone P, Santulli G. Tirzepatide: A Systematic Update. Int J Mol Sci. 2022 Nov 23;23(23):14631. doi: 10.3390/ijms232314631. PMID 36498958
• Wadden TA, Chao AM, Machineni S, Kushner R, Ard J, Srivastava G, Halpern B, Zhang S, Chen J, Bunck MC, Ahmad NN, Forrester T. Tirzepatide after intensive lifestyle intervention in adults with overweight or obesity: the SURMOUNT-3 phase 3 trial. Nat Med. 2023 Nov;29(11):2909-2918. doi: 10.1038/s41591-023-02597-w. Epub 2023 Oct 15. PMID 37840095
• Jastreboff AM, Aronne LJ, Ahmad NN, Wharton S, Connery L, Alves B, Kiyosue A, Zhang S, Liu B, Bunck MC, Stefanski A; SURMOUNT-1 Investigators. Tirzepatide Once Weekly for the Treatment of Obesity. N Engl J Med. 2022 Jul 21;387(3):205-216. doi: 10.1056/NEJMoa2206038. Epub 2022 Jun 4. PMID 35658024

Идентификаторы

NCT: NCT07099742 · Bex-2502004

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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