AMAZE 8: A Research Study Investigating How Well the Medicine NNC0487-0111 Compared to Semaglutide Helps People With Excess Body Weight and Type 2 Diabetes Lose Weight

Официальное название

Efficacy and Safety of NNC0487-0111 s.c. Once-weekly Compared to Semaglutide s.c. Once-weekly in Participants With Overweight or Obesity, and Type 2 Diabetes (AMAZE 8)

Обзор

The purpose of this clinical study is to find out if NNC0487-0111 is safe and effective for treating people who have excess body weight and type 2 diabetes. Participant will receive 2 injections every week: an active medicine and a placebo, both taken as injections under the skin once a week. The placebo is a treatment with no active medicine in it and will be given to all participants. In addition to placebo, participants will receive either of the active medicine NNC0487-0111 (the treatment being tested) or Semaglutide (an approved and commonly prescribed treatment used as comparator). Which treatment participants get is decided by chance.

Вмешательства

• Препарат NNC0487-0111
  NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.
• Препарат Semaglutide
  Semaglutide will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.
• Препарат Placebo (matched to NNC0487-0111)
  Placebo matched to NNC0487-0111 will be administered subcutaneously using pre- filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.
• Препарат Placebo (matched to semaglutide)
  Placebo matched to semaglutide will be administered subcutaneously using pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.

Первичные конечные точки

• Relative change in body weight [Срок оценки: From baseline (week 0) to week 84]

Вторичные конечные точки (12)

• Change in waist circumference [Срок оценки: From baseline (week 0) to week 84]
• Change in systolic blood pressure (SBP) [Срок оценки: From baseline (week 0) to week 84]
• Change in body weight [Срок оценки: From baseline (week 0) to week 84 and week 104]
• Change in body mass index (BMI) [Срок оценки: From baseline (week 0) to week 84 and week 104]
• Number of participants with achievement of in haemoglobin A1c (HbA1c) < 7.0 percent (%) (yes/no) [Срок оценки: From baseline (week 0) to week 84]
• Number of participants with achievement of HbA1c ≤ 6.5% (yes/no) [Срок оценки: From baseline (week 0) to week 84]
• Number of participants with achievement of HbA1c < 5.7% (yes/no) [Срок оценки: From baseline (week 0) to week 84]
• Change in fasting plasma glucose (FPG) measured as millimole per liter (mmol/L) [Срок оценки: From baseline (week 0) to week 84]
• Change in FPG measured as milligrams per deciliter (mg/dL) [Срок оценки: From baseline (week 0) to week 84]
• Ratio to baseline: change in fasting insulin [Срок оценки: From baseline (week 0) to week 84]
• Ratio to baseline: change in urinary albumin-to-creatinine ratio (UACR) [Срок оценки: From baseline (week 0) to week 84]
• Change in diastolic blood pressure (DBP) [Срок оценки: From baseline (week 0) to week 84]

Критерии участия

Критерии включения

• Male or female (sex at birth).
• Age 18 years or above at the time of signing informed consent.
• Diagnosed with type 2 diabetes mellitus ≥ 180 days before screening.
• Haemoglobin A1c (HbA1c) 7-10 percentage (%) (53-86 millimole per mole \[mmol/mol\]) (both inclusive) as measured by the central laboratory at screening.
• Treatment with lifestyle intervention, and/or 0-3 marketed oral antidiabetic drugs (OAD)s (metformin, α-glucosidase inhibitors (AGI), glinides, sodium-glucose cotransporter 2 inhibitor (SGLT2i), thiazolidinediones, or sulfonylureas (SU) as a single agent or in combination) according to local label. Treatment with oral antidiabetic drugs should be stable (same drug(s), dose and dosing frequency) before screening.

Критерии исключения

• Renal impairment with estimated Glomerular Filtration Rate (eGFR) < 30 milliliter (mL)/ minute (min)/1.73 meter squared (m\^2) (2021 Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] formula), at screening.
• Participant with diabetic retinopathy or maculopathy who received treatment with retinal photocoagulation, vitrectomy or anti-Vascular Endothelial Growth Factor (anti-VEGF) within 180 days before screening or are expected to require treatment within 180 days after screening. Diabetic retinopathy or maculopathy must be verified by an eye examination performed within 90 days before screening or in the period between screening and randomization. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
• Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire question 8.
• Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator.
• Treatment with glucagon-like peptide-1 (GLP-1) receptor agonists (RA), dual GLP-1/gastric inhibitory peptide (GIP) RAs (or any other GLP-1 based treatment), or amylin analogues before screening.

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

Четверное слепое

Основная цель

Лечение

Центры проведения

Польша · 20 центров

• Gabinety Medyczne MATUSZEK Beata Matyjaszek-Matuszek Prywatna Praktyka Specjalistyczna — Lublin
• EKAMED sp. z o.o. — Lublin
• Przychodnie Grudziadz Sp. z o. o. — Grudziądz
• Legeartis Poradnie Specjalistyczne Sp. z o.o. — Bialystok
• NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Małgorzata Arciszewska — Bialystok
• NZOZ Vita-Diabetica Malgorzata Buraczyk — Bialystok
• Centrum Kliniczno-Badawcze J.Brzezicki B.Gornikiewicz-Brzezicka Lekarze sp.p. — Elblag
• Specjalistyczny Gabinet Diabetologiczny Radoslaw Rumianowski — Gorzów Wielkopolski
• … и ещё 12 центров

Индия · 18 центров

• Endolife Specialty Hospitals — Guntur
• Nirmal Hospital Pvt. Ltd. — Surat
• SSG Hospital, Baroda — Vadodara
• Diacon Hospital Private Limited — Bangalore
• Lifecare Hospital and Research Centre — Bengaluru
• Amrita Institute Of Medical Sciences & Research Centre — Kochi
• TOTALL Diabetes Hormone Institute — Indore
• BSES MG hospital — Mumbai
• … и ещё 10 центров

Болгария · 11 центров

• Dr. Tatyana Metalova - AIPSMCE EOOD — Gotse Delchev
• Medical centre Zdrave 1 OOD — Kozloduy
• UMHAT Pulmed OOD - Pazardzhik, Department of Internal Diseases — Pazardzhik
• MHAT Heart and Brain EAD - Pleven, Endocrinology and Metabolic Diseases — Pleven
• DCC I- Pleven EOOD Endocrinology — Pleven
• MHAT Knyaginya Klementina - Sofia EAD — Sofia
• MHAT Sveta Sofia EOOD, Department of Endocrinology and Metabolic diseases — Sofia
• Acibadem City Clinic UMHAT Tokuda EAD, Endocrinology — Sofia
• … и ещё 3 центра

США · 10 центров

• Encore Medical Research LLC — Hollywood
• Optimal Research Sites — Orange City
• Encore Medical Research of Weston — Weston
• Endocrine Research Solutions, Inc — Roswell
• Elite Clinical Trials — Blackfoot
• Endo And Metab Cons — Rockville
• Arcturus Healthcare, PLC. — Troy
• Velocity Clin Res, Dallas — Dallas
• … и ещё 2 центра

Германия · 10 центров

• Herz- und Diabeteszentrum NRW - Bad Oeynhausen — Bad Oeynhausen
• Zentrum fuer klinische Studien Suedbrandenburg GmbH — Elsterwerda
• Praxis am Markt Dr. Becker — Essen
• MVZ im Altstadt-Carree Fulda GmbH - Zentrum für klinische Studien — Fulda
• Diabetes-Zentrum-Wilhelmsburg GbR — Hamburg
• Diabetologische Gemeinschaftspraxis Dr. Staudenmeyer und Dr. Schiwietz — Lingen
• SMO.MD GmbH - Zentrum für klinische Studien — Magdeburg
• Institut für Diabetesforschung Osnabrück — Osnabrück
• … и ещё 2 центра

Хорватия · 8 центров

• Poliklinika Medikol Zagreb — Grad Zagreb
• Opca bolnica Karlovac — Karlovac
• Specijalna Bolnica za medicinsku rehabilitaciju Krapinske Toplice_Endocrinology — Krapinske Toplice
• Poliklinika SLAVONIJA OSIJEK — Osijek
• Clinical Hospital Centre Rijeka_Endocrinology — Rijeka
• General Hospital Dr. Josip Bencevic_Diabetic department — Slavonski Brod
• Opca bolnica Varazdin_Endocrinology — Varaždin
• Poliklinika Solmed — Zagreb

Португалия · 8 центров

Список центров уточняется — проверьте первичный протокол.

Румыния · 8 центров

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Turkey (Türkiye) · 7 центров

Список центров уточняется — проверьте первичный протокол.

Венгрия · 5 центров

• Debreceni Egyetem — Debrecen
• Komáromi Selye János Kórház — Komárom
• Óbudai Egészségügyi Centrum — Budapest
• Borbánya Praxis E.Ü. Kft. — Nyíregyháza
• Békés Vármegyei Központi Kórház — Gyula

Таиланд · 5 центров

Список центров уточняется — проверьте первичный протокол.

Бразилия · 4 центра

• Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda. — Porto Alegre
• i9 Pesquisas Clínicas — Campinas
• CPQuali Pesquisa Clínica Ltda — São Paulo
• BR Trials - Ensaios Clínicos e Consultoria Ltda. — São Paulo

Аргентина · 3 центра

• Centro de Investigaciones Metabólicas — Capital Federal
• Centro Médico CIMEL — Lanús Este
• Centro Médico Privado San Vicente Diabetes — Córdoba

Мексика · 3 центра

• Diseño y Planeación en Investigación Médica S.C. — Guadalajara
• Alliance CEINV Salud S.A. de C.V. — Monterrey
• Centro de Estudios de Investigación Metabólicos y Cardio — Ciudad Madero

Идентификаторы

NCT: NCT07400107 · NN9490-8028 · U1111-1313-8017 · 2024-520446-31

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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