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Набира участници Фаза 4 NCT07438444

A Study of Tirzepatide (LY3298176) in Adult Participants in India With Either Type 2 Diabetes Mellitus or Obesity

Фаза 4 – наблюдение след одобрението на пазара
Заболявания: Diabetes Mellitus, Type 2 Obesity Overweight

Спонсор: Eli Lilly and Company

Налично на: БГ
Обобщение
The main purpose of this study is to measure the safety and efficacy of tirzepatide in adult participants in India who have type 2 diabetes or who have obesity or overweight without type 2 diabetes. Participation in the study will last about 46 weeks.
Кой може да участва
Inclusion Criteria: Participants with Type 2 Diabetes: * Have had type 2 diabetes for at least one year * Insulin naive * Have HbA1c ≥7.5% and ≤10% at screening * Have body mass index (BMI) ≥23 kilograms per square meter (kg/m2) Participants with Obesity or Overweight without Type 2 Diabetes: * Have a BMI * Greater than or equal to 30 kg/m2 OR * Greater than or equal to 27 kg/m2 AND previously diagnosed with at least one of the following weight-related comorbidities: high blood pressure, lipid disorder, obstructive sleep apnea, heart disease Exclusion Criteria: Participants with Type 2 Diabetes: * Have type 1 diabetes * Have had any of the following heart conditions within 6 months prior to screening: * heart attack * stroke * hospitalization due to heart failure * Have New York Heart Association Functional Classification Class III or IV congestive heart failure (CHF) * Have type 2 diabetes along with morbid obesity and being considered for bariatric surgery or any other procedure intended for weight loss Participants with Obesity or Overweight without Type 2 Diabetes: * Have type 1 diabetes or type 2 diabetes * Have a self-reported change in body weight greater than 5 kilograms (kg) (11 pounds) within 3 months prior to screening * Have a prior or planned surgical treatment for obesity * Have had any of the following heart conditions within 6 months prior to screening: * heart attack * stroke * hospitalization due to heart failure * Have New York Heart Association Functional Classification Class III or IV CHF * Have taken any medications or alternative remedies for weight loss within 3 months prior to screening
Интервенции
Tirzepatide
DRUG
Места на провеждане 21
Индия (21)
B. J. Medical College & Civil Hospital
Ahmedabad
V.S. General Hospital
Ahmedabad
NOT_YET_RECRUITING
Gujarat Endocrine Center
Ahmedabad
Jawahar Lal Nehru Medical College
Ajmer
NOT_YET_RECRUITING
Motilal Nehru Medical College Hospital
Allahābād
Lifecare Hospital and Research Centre
Bengaluru
AIIMS, Bhubaneshwar
Bhubaneswar
NOT_YET_RECRUITING
Sri Ramachandra MedicaL College & Research Institute
Chennai
Kovai Diabetes Speciality Center and Hospital
Coimbatore
Apollo Excelcare Hospital
Guwahati
Osmania Medical College & Hospital
Hyderabad
Eternal Heart Care Center and Research Institute
Jaipur
K care Hospital
Kanpur
Brij Medical Centre Private Limited
Kanpur
NOT_YET_RECRUITING
ILS Hospitals
Kolkata
Government Medical College, Kozhikode
Kozhikode
Wockhardt Hospitals
Mumbai
NOT_YET_RECRUITING
Shri Krishna Hrudayalaya & Critical Care Centre
Nagpur
Sahyadri Super Speciality Hospital
Pune
All India Institute of Medical Sciences
Raipur
NOT_YET_RECRUITING
King George Hospital, Andhra Medical College
Visakhapatnam
NOT_YET_RECRUITING
Технически детайли
Статус
Набира участници
Фаза
Фаза 4
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
27.02.2026
Крайна дата
01.10.2027
Регистрационен номер
NCT07438444
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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