A Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes Who Observe Ramadan Fasting

Официальное название

A Phase 3b, Multicenter, Multi-Country, Open-Label, Single-Arm Study to Investigate the Efficacy and Safety of Orforglipron in Adult Participants With Type 2 Diabetes Who Observe Ramadan Fasting (ACHIEVE-RAM)

Обзор

The purpose of this study is to test the efficacy and safety of orforglipron in participants with T2D (type 2 diabetes) who participate in fasting during Ramadan. For each participant, the study will last up to 48 weeks with a minimum of 7 in clinic visits and 4 virtual visits.

Вмешательства

• Препарат Orforglipron
  Administered orally

Первичные конечные точки

• Change from Baseline in Hemoglobin A1C (HbA1c) [Срок оценки: Baseline, up to 8 Weeks after Start of Ramadan]

Вторичные конечные точки (6)

• Percentage of Participants with an HbA1c of less than (<) 7 Percent (%) (53 millimeters per mole (mmol/mol)) [Срок оценки: Baseline, Up to 8 Weeks after Start of Ramadan]
• Change From Baseline in Fasting Serum Glucose (FSG) [Срок оценки: Baseline, Up to 8 Weeks after Start of Ramadan]
• Percent Change from Baseline in Body Weight [Срок оценки: Baseline, Up to 8 Weeks after Start of Ramadan]
• Change in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Index [Срок оценки: Baseline, Up to 8 Weeks after Start of Ramadan]
• Percent Change in HbA1c [Срок оценки: 4 Weeks Prior to Ramadan, Up to Week 8 after Start of Ramadan]]
• Percent Change in Body Weight [Срок оценки: 4 Weeks Prior to Ramadan, Up to Week 8 after Start of Ramadan]]

Критерии участия

Критерии включения

• Have a clinical diagnosis of T2D based on the World Health Organization (WHO) classification or other locally applicable diagnostic standards.
• Have an HbA1c value of at least 7.0% (53 millimoles per mole (mmol/mol)) to less than 9.5% (91 mmol/mol) at screening.
• Intend to be compliant with the fast during the Ramadan period.
• Have had stable body weight self-reported change of 5 kilograms (kg) or lower during the 90 days prior to screening.
• Have body mass index (BMI) of 25 kilograms per meter square (kg/m2) or higher at screening.

Критерии исключения

• Have any form of diabetes other than T2D, including type 1 diabetes (T1D), gestational diabetes, latent autoimmune diabetes, maturity-onset diabetes of the young, and medication-induced diabetes
• Have a family (first-degree relative) or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2.
• Have a history of chronic or acute pancreatitis any time prior to screening
• Have evidence of a significant, uncontrolled endocrine abnormality, for example, thyrotoxic or adrenal crises, in the opinion of the investigator
• Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years.
• Have a history of cholecystectomy (surgically removed gallbladder)
• Have New York Heart Association Functional Classification IV congestive heart-failure.

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

ЮАР · 14 центров

• JOSHA Research — Bloemfontein
• TREAD Research — Cape Town
• TASK Central — Cape Town
• Tiervlei Trial Centre — Cape Town
• Synopsis Research — Cape Town
• Synergy Biomed Research Institute (SBRI) — East London
• Aliwal Shoal Medical Centre — eMkhomazi
• Fola Health — Johannesburg
• … и ещё 6 центров

Индия · 9 центров

• Sarojini Naidu Medical College — Agra
• Osmania General Hospital — Hyderabad
• Brij Medical Centre Pvt. Ltd. — Kanpur
• Apollo Multispeciality Hospitals limited — Kolkata
• KGN Diabetes and Endocrinology Centre — Mumbai
• Mysore Medical College and Research Institute — Mysore
• Supe Heart & Diabetes Hospital & Research Centre — Nashik
• Diabetes Clinic — Nellore
• … и ещё 1 центр

Саудовская Аравия · 9 центров

• King Abdulaziz University for Health Sciences Ministry of National Guard Health Affairs — Al-Ahsa
• King Fahad Specialist Hospital — Dammam
• National Guard Health Affairs: King Abdulaziz Medical City — Jeddah
• Dr. Soliman Fakeeh Hospital — Jeddah
• King Abdulaziz University Hospital — Jeddah
• King Fahad Armed Forces Hospital Jeddah — Jeddah
• King Saud University Medical City — Riyadh
• Dr. Soliman Fakeeh Hospital — Riyadh
• … и ещё 1 центр

ОАЭ · 5 центров

• Sheikh Khalifa Medical City — Abu Dhabi
• NMC Abu Dhabi — Abu Dhabi
• Tawam Hospital — Al Ain City
• Emirates Hospital Dubai — Dubai
• Dubai Hospital — Dubai

Идентификаторы

NCT: NCT07613307 · 27746 · J2A-MC-GZPV

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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