Activo, sin reclutamientoNCT07400107Registro de ClinicalTrials.gov

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

Obesity · Overweight · Diabetes Mellitus, Type 2

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LO ESENCIAL

De qué trata este estudio

El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.

Tipo de estudio: De intervención
Fase: Fase 3
Rango de edad: 18 años - No especificado
Sexo admitido: Todos los sexos
Voluntarios sanos: No aceptados
Participantes: 985 Real

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

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.

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

Key Inclusion Criteria:

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.

Key Exclusion Criteria:

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.

Entiende la evaluación inicial

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación: Asignación al azar
Enmascaramiento: Enmascaramiento cuádruple

NNC0487-0111

Participants will receive NNC0487-0111 and placebo matched to semaglutide subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.

Drug: NNC0487-0111 · Drug: Placebo (matched to semaglutide)

Semaglutide

Participants will receive semaglutide and placebo matched to NNC0487-0111 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.

Drug: Semaglutide · Drug: Placebo (matched to NNC0487-0111)

NNC0487-0111 DRUG

NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.

Semaglutide DRUG

Semaglutide will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.

Placebo (matched to NNC0487-0111) DRUG

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.

Placebo (matched to semaglutide) DRUG

Placebo matched to semaglutide will be administered subcutaneously using pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.

Prepara tus preguntas

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Relative change in body weight

Plazo: From baseline (week 0) to week 84

Measured as percentage of body weight.

Medidas secundarias

Change in waist circumference

Plazo: From baseline (week 0) to week 84

Measured as centimeter (cm).

Change in systolic blood pressure (SBP)

Plazo: From baseline (week 0) to week 84

Measured as millimeter of mercury (mmHg).

Change in body weight

Plazo: From baseline (week 0) to week 84 and week 104

Measured as kilograms (kg).

Change in body mass index (BMI)

Plazo: From baseline (week 0) to week 84 and week 104

Measured as kilograms per meter squared (kg/m\^2).

Number of participants with achievement of in haemoglobin A1c (HbA1c) < 7.0 percent (%) (yes/no)

Plazo: From baseline (week 0) to week 84

Measured as count of participants.

Number of participants with achievement of HbA1c ≤ 6.5% (yes/no)

Plazo: From baseline (week 0) to week 84

Measured as count of participants.

Number of participants with achievement of HbA1c < 5.7% (yes/no)

Plazo: From baseline (week 0) to week 84

Measured as count of participants.

Change in fasting plasma glucose (FPG) measured as millimole per liter (mmol/L)

Plazo: From baseline (week 0) to week 84

Measured as mmol/L.

Change in FPG measured as milligrams per deciliter (mg/dL)

Plazo: From baseline (week 0) to week 84

Measured as mg/dL.

Ratio to baseline: change in fasting insulin

Plazo: From baseline (week 0) to week 84

Measured as ratio.

Ratio to baseline: change in urinary albumin-to-creatinine ratio (UACR)

Plazo: From baseline (week 0) to week 84

Measured as ratio.

Change in diastolic blood pressure (DBP)

Plazo: From baseline (week 0) to week 84

Measured as mmHg.

Ratio to baseline: change in total cholesterol

Plazo: From baseline (week 0) to week 84

Measured as ratio.

Ratio to baseline: change in high-density lipoprotein (HDL) cholesterol

Plazo: From baseline (week 0) to week 84

Measured as ratio.

Ratio to baseline: change in low-density lipoprotein (LDL) cholesterol

Plazo: From baseline (week 0) to week 84

Measured as ratio.

Ratio to baseline: change in very low-density lipoprotein (VLDL) cholesterol

Plazo: From baseline (week 0) to week 84

Measured as ratio.

Ratio to baseline: change in non-HDL cholesterol

Plazo: From baseline (week 0) to week 84

Measured as ratio.

Ratio to baseline: change in triglycerides

Plazo: From baseline (week 0) to week 84

Measured as ratio.

Ratio to baseline: change in high-sensitivity C-reactive protein (hsCRP)

Plazo: From baseline (week 0) to week 84

Measured as ratio.

Number of Treatment Emergent Adverse Events (TEAEs)

Plazo: From baseline (week 0) to week 84 and week 109

Measured as events.

Number of Treatment Emergent Serious Adverse Events (TESAEs)

Plazo: From baseline (week 0) to week 84 and week 109

Measured as events.

Number of TEAEs leading to permanent treatment discontinuation

Plazo: From baseline (week 0) to week 84 and week 109

Measured as events.

Number of treatment-emergent clinically significant hypoglycaemic episodes (level 2) (< 3.0 millimole per liter [mmol/L] (54 milligrams per deciliter [mg/dL]), confirmed by a blood glucose (BG) meter)

Plazo: From baseline (week 0) to week 84 and week 109

Measured as episodes.

Number of treatment-emergent severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold

Plazo: From baseline (week 0) to week 84 and week 109

Measured as episodes.

El registro no indica resultados publicados.

Revisa las tablas completas y sus limitaciones en el registro oficial.

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Centros de investigación (122)

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122 centros

Encore Medical Research LLCHollywood, Florida, United StatesEstado desconocido

De qué trata este estudio

Acerca de la investigación

¿Quién podría participar?

Tratamiento, grupos y participación

Qué evalúan los investigadores

Medidas principales

Medidas secundarias

Centros de investigación (122)

Equipo y fechas

Contactos oficiales del estudio

Consulta a Wellness Clinical Research