A Research Study Comparing How Well Different Doses of the Medicine NNC0662-0419 Lower Blood Sugar in People With Type 2 Diabetes

Официальное название

Efficacy and Safety of Once-weekly Subcutaneous NNC0662-0419 in Participants With Type 2 Diabetes - a Dose-finding Study

Обзор

This study is being done to look at the effect and safety of different doses of NNC0662-0419 in people living with type 2 diabetes when compared to placebo or semaglutide. The purpose of this clinical study is to find out if NNC0662-0419 is effective and safe for treating people living with type 2 diabetes. Participants will get either NNC0662-0419, semaglutide or placebo. Which treatment participants get is decided by chance. NNC0662-0419 is a new medicine which cannot be prescribed by doctors but has previously been tested in humans. Semaglutide is an approved medication to treat type 2 diabetes.

Вмешательства

• Препарат NNC0662-0419
  NNC0662-0419 will be administered subcutaneously.
• Препарат Semaglutide
  Semaglutide will be administered subcutaneously.
• Препарат Placebo
  Placebo will be administered subcutaneously.

Первичные конечные точки

• Change in glycated haemoglobin (HbA1c) (week 16) [Срок оценки: From baseline (week 0) to week 16]
• Change in HbA1c (week 28) [Срок оценки: From baseline (week 0) to week 28]
• Change in HbA1c (week 40) [Срок оценки: From baseline (week 0) to week 40]

Вторичные конечные точки (12)

• Relative change in body weight [Срок оценки: From baseline (week 0) to (week 40)]
• Change in body weight [Срок оценки: From baseline (week 0) to (week 40)]
• Change in HbA1c [Срок оценки: From baseline (week 0) to (week 16, 28 and 40)]
• Change in Fasting Plasma Glucose (FPG) [Срок оценки: From baseline (week 0) to (week 16, 28 and 40)]
• Change in Body Mass Index (BMI) [Срок оценки: From baseline (week 0) to (week 40)]
• Change in waist circumference [Срок оценки: From baseline (week 0) to (week 40)]
• Change in high sensitivity C-Reactive Protein (hsCRP) [Срок оценки: From baseline (week 0) to (week 40)]
• Change in total cholesterol [Срок оценки: From baseline (week 0) to (week 40)]
• Change in High-Density Lipoprotein (HDL) cholesterol [Срок оценки: From baseline (week 0) to (week 40)]
• Change in Low-Density Lipoprotein (LDL) cholesterol [Срок оценки: From baseline (week 0) to (week 40)]
• Change in triglycerides [Срок оценки: From baseline (week 0) to (week 40)]
• Change in Urine Albumin Creatinine Ratio (UACR) [Срок оценки: From baseline (week 0) to (week 16, 28 and 40)]

Критерии участия

Критерии включения

• Male or female (sex at birth).
• Age 18-75 years (both inclusive) at the time of signing the informed consent.
• Glycated haemoglobin (HbA1c) of 7.0-10.0 percent (%) (53-86 millimoles per mole \[mmol/mol\]) (both inclusive) as assessed by central laboratory at screening.
• Willingness to obtain a high weight loss (greater than \[>\] 25% of weight at baseline).

Критерии исключения

• Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days and prior insulin treatment for gestational diabetes are allowed.
• Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. 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.

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

США · 23 центра

• First Valley Medical Group — Lancaster
• Torrance Clinical Research Institute, Inc. — Lomita
• Ark Clinical Research — Long Beach
• Pacific Clinical Studies — Los Alamitos
• Wetlin Research Associates, Inc. — San Diego
• Diablo Clinical Research, Inc. — Walnut Creek
• Encore Medical Research LLC — Hollywood
• Bioclinical Research Alliance — Miami
• … и ещё 15 центров

Испания · 6 центров

• ABS La Roca CAP Vicenç_Endocrino — La Roca Del Vallés
• Centro de Salud A Estrada — A Estrada
• Equip D´Atencio Primaria Barcelona Sardenya — Barcelona
• Hospital Vithas Sevilla — Castilleja de la Cuesta
• Clínica Bofill — Girona
• Centro de Saúde Concepción Arenal — Santiago de Compostela

Япония · 5 центров

• Akaicho Clinic_Internal medicine — Chiba-shi, Chiba
• Naka Kinen Clinic_Internal medicine — Ibaraki
• Soka Sugiura Internal Medicine Clinic — Soka-shi, Saitama
• Tokyo-Eki Center-building Clinic_Internal Medicine — Tokyo
• ToCROM Clinic_Internal Medicine — Tokyo

Польша · 5 центров

• "Zdrowie Osteo-Medic" s.c. Lidia i Artur Racewicz, Agnieszka i Jerzy Supronik — Bialystok
• Terpa Sp. z o.o. Sp. k. — Lublin
• Formed 2 Sp. z o.o. — Oświęcim
• PANSTWOWY INSTYTUT MEDYCZNY MSWiA — Warsaw
• Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Szyszko — Zabrze

Таиланд · 5 центров

• Ramathibodi Hospital — Bangkok
• Siriraj Hospital — Bangkok
• Maharaj Nakorn Chiang Mai — Chiang Mai
• Srinagarind Hospital — Khon Kaen
• Maharat Nakhon Ratchasima Hospital — Nakhon Ratchasima

Хорватия · 4 центра

• Opca bolnica Karlovac — Karlovac
• Poliklinika SLAVONIJA OSIJEK — Osijek
• Opca bolnica Varazdin_Endocrinology — Varaždin
• Poliklinika Solmed — Zagreb

Португалия · 4 центра

• Casa De Saúde De Santa Filomena S.A._Unidade de Ensaios Clínicos — Coimbra
• Cardiolima Centro Diagnostico Cardio-Pulmonar De Ponte De Lima Lda — Ponte de Lima
• Hospital Trofa Saude Senhor do Bonfim S.A_Unidade de Ensaios Clínicos — Vila do Conde
• Hospital da Luz Arrábida, S.A_Serviço de Endocrinologia — Vila Nova de Gaia

Словакия · 4 центра

• DIADA, s.r.o. — Bardejov
• Metabol KLINIK s.r.o. — Bratislava
• Diacrin s. r. o. — Bratislava
• SIN AZUCAR s.r.o. — Malacky

South Korea · 4 центра

• Korea University Ansan Hospital_Endocrinology — Ansan-si
• Pusan National University Yangsan Hospital — Yangsan
• Nowon Eulji Medical Center, Eulji University_Endocrinology — Seoul
• Kangbuk Samsung Hospital_Endocrinology — Seoul

Венгрия · 3 центра

• Szegedi Tudomanyegyetem St Györgyi Albert Klinikai Központ — Szeged
• Debreceni Egyetem — Debrecen
• Debreceni Egyetem — Debrecen

Идентификаторы

NCT: NCT07415954 · NN9662-8160 · U1111-1324-0310 · 2025-523260-20

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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