A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes (SELENE-Asia)
A Phase III, Randomised, Double-Blind, Placebo-Controlled, Multicentre Trial to Evaluate the Efficacy and Safety of AZD6234 in Participants With Obesity or Overweight With at Least One Weight Related Comorbidity With or Without Type 2 Diabetes Mellitus (SELENE-Asia)
This study will evaluate the efficacy and safety of AZD6234 compared with placebo in adults who are overweight or obese, with or without type 2 diabetes mellitus.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 3
Contactos y Ubicaciones
Estudio Contacto
- Nombre: AstraZeneca Clinical Study Information Center
- Número de teléfono: 1-877-240-9479
- Correo electrónico: information.center@astrazeneca.com
Ubicaciones de estudio
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Ansārinagar, India, 110 029
- Research Site
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Calicut, India, 673008
- Research Site
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Kolkata, India, 700014
- Research Site
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Ludhiana, India, 141001
- Research Site
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Meerut, India, 250005
- Research Site
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Surat, India, 395002
- Research Site
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Beijing, Porcelana, 100029
- Research Site
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Bozhou, Porcelana, 236000
- Research Site
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Cangzhou, Porcelana, 061002
- Research Site
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Changzhou, Porcelana, 213004
- Research Site
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Chongqing, Porcelana, 402260
- Research Site
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Daqing, Porcelana, 163316
- Research Site
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Ganzhou, Porcelana, 341099
- Research Site
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Guangzhou, Porcelana, 510150
- Research Site
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Guangzhou, Porcelana, 510800
- Research Site
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Jiaxing, Porcelana, 314001
- Research Site
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Jinan, Porcelana, 250031
- Research Site
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Jinan, Porcelana, 250013
- Research Site
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Liuzhou, Porcelana, 545005
- Research Site
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Luoyang, Porcelana, 471003
- Research Site
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Luzhou, Porcelana, 646000
- Research Site
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Sanya, Porcelana, 572000
- Research Site
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Shanghai, Porcelana, 200031
- Research Site
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Shanghai, Porcelana, 310000
- Research Site
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Shanghai, Porcelana, 201700
- Research Site
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Shenyang, Porcelana, 110016
- Research Site
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Shenyang, Porcelana, 110023
- Research Site
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Shiyan, Porcelana, 442099
- Research Site
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Suzhou, Porcelana, 215004
- Research Site
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Wuhan, Porcelana, 430060
- Research Site
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Xi'an, Porcelana, 710068
- Research Site
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Xuancheng, Porcelana, 242000
- Research Site
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Yuncheng, Porcelana, 044099
- Research Site
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Zhengzhou, Porcelana, 450007
- Research Site
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Aged 18 years or older at the time of signing informed consent.
- Body mass index:
- at least 28 kg/m²; or
- at least 24 kg/m² and less than 28 kg/m² with at least one protocol-defined weight-related comorbidity, including type 2 diabetes mellitus, hypertension, dyslipidaemia, obstructive sleep apnoea, cardiovascular disease, heart failure, chronic kidney disease, metabolic dysfunction-associated steatotic liver disease, knee osteoarthritis, or stress urinary incontinence.
- Stable body weight (≤ 5% body weight change) for at least 3 months prior to Randomisation.
- Participants with type 2 diabetes mellitus must:
- have been diagnosed at least 6 months before informed consent;
- have HbA1c between 6.0% and 10.0% at Screening; and
- be managed with diet and exercise alone or with a stable dose of 1 to 3 oral glucose-lowering medications for at least 3 months before Screening.
- At least one previous self-reported unsuccessful attempt to lose body weight.
- Participants of childbearing potential must comply with protocol-defined highly effective contraception requirements and have negative pregnancy tests at Screening and Randomisation.
- Able to provide signed informed consent.
Exclusion Criteria:
- Obesity primarily caused by another endocrine disorder.
- Severe heart failure, defined as New York Heart Association Class IV, or hospitalisation for heart failure within 3 months before Screening.
- Type 1 diabetes mellitus or ketoacidosis or hyperosmolar coma/state within 3 months before Screening.
- Clinically significant gastric-emptying abnormality requiring treatment.
- Significant inflammatory bowel disease or another severe disease or prior surgery affecting the upper gastrointestinal tract.
- Cardiovascular event, percutaneous coronary intervention, or coronary artery bypass graft within 3 months before Screening.
- Previous or planned surgical treatment for obesity.
- Uncontrolled hypothyroidism or hyperthyroidism.
- Significant hepatobiliary disease, including protocol-defined elevations in alanine aminotransferase, aspartate aminotransferase, or total bilirubin.
- Neoplastic disease within 5 years before Screening, except as otherwise permitted by the protocol.
- Clinically important disease or disorder that may place the participant at risk or interfere with study participation.
- Known or suspected drug abuse or alcohol abuse.
- Planned elective surgery requiring discontinuation of study intervention for more than 6 weeks.
- Weight-management treatment within 3 months before Randomisation.
- Treatment with a glucagon-like peptide-1 receptor agonist or another glucagon-like peptide-1-containing medication within 3 months before Randomisation.
- Treatment with a marketed or investigational amylin-based compound within 3 months before Randomisation.
- Use of insulin therapy for type 2 diabetes mellitus.
- Long-term systemic glucocorticoid treatment lasting more than 14 days or use of central nervous system stimulants.
- Concomitant medication that may increase risk, affect study results, or interfere with study participation.
- Unstable major depressive disorder or Patient Health Questionnaire-9 score of 15 or higher.
- History of psychosis or active symptomatic bipolar disorder.
- Active suicidal ideation corresponding to Category 4 or 5 on the Columbia-Suicide Severity Rating Scale, or history of a suicide attempt.
- Participation in another clinical study within 30 days before Screening.
- Known hypersensitivity to AZD6234.
- Involvement in the planning and/or conduct of the study.
- Unlikely or unable to comply with study procedures, restrictions, or requirements.
- Previous randomisation in the present study.
- Currently pregnant or breastfeeding.
- Any other condition that, in the Investigator's judgement, makes participation inappropriate.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: AZD6234 Higher Target-Dose
Participants will receive AZD6234 with dose titration to the higher target dose, followed by a safety follow-up period. |
administered once weekly. |
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Experimental: AZD6234 Lower Target-Dose
Participants will receive AZD6234 with dose titration to the lower target dose, followed by a safety follow-up period. |
administered once weekly. |
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Comparador de placebos: Placebo
Participants will receive matching placebo with dose titration according to the protocol, followed by a safety follow-up period. |
Matching placebo administered once weekly. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Percent change in body weight from baseline at Week 64
Periodo de tiempo: up to 64 weeks
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To evaluate the effect of AZD6234 as compared to placebo in percent body weight change from baseline of treatment. |
up to 64 weeks
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Number of participants achieving at Least a 5% Reduction in Body Weight From Baseline at Week 64
Periodo de tiempo: up to 64 weeks
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To evaluate the effect of AZD6234 as compared to placebo in body weight loss of at least 5% from baseline of treatment. |
up to 64 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number of participants achieving at Least a 10% Reduction in Body Weight From Baseline at Week 64
Periodo de tiempo: up to 64 weeks
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To evaluate the effect of AZD6234 as compared to placebo in body weight loss of at least 10% from baseline of treatment. |
up to 64 weeks
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Change in waist circumference from baseline
Periodo de tiempo: up to 64 weeks
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To evaluate the effect of AZD6234 as compared to placebo in waist circumference change from baseline of treatment. |
up to 64 weeks
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Absolute change in weight from baseline
Periodo de tiempo: up to 64 weeks
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To evaluate the effect of AZD6234 as compared to placebo on absolute change in weight from baseline of treatment. |
up to 64 weeks
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Percent change in triglycerides from baseline
Periodo de tiempo: up to 64 weeks
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To evaluate the effect of AZD6234 as compared to placebo on triglycerides percent change from baseline of treatment. |
up to 64 weeks
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Change in systolic BP from baseline
Periodo de tiempo: up to 64 weeks
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To evaluate the effect of AZD6234 as compared to placebo on systolic BP change from baseline of treatment. |
up to 64 weeks
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Number of Participants With Adverse Events
Periodo de tiempo: From first administration through Week 64 and the 4-week safety follow-up
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Number of participants with prespecified adverse event categories. |
From first administration through Week 64 and the 4-week safety follow-up
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del sistema endocrino
- Trastornos Nutricionales
- Enfermedades metabólicas
- Sobrenutrición
- Peso corporal
- Trastornos del metabolismo de la glucosa
- Diabetes mellitus
- Condiciones Patológicas, Signos y Síntomas
- Enfermedades Nutricionales y Metabólicas
- Signos y síntomas
- Exceso de peso
- Obesidad
- Diabetes Mellitus, Tipo 2
Otros números de identificación del estudio
- D8750C00019
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Marco de tiempo para compartir IPD
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Criterios de acceso compartido de IPD
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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