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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 3
Contatti e Sedi
Contatto studio
- Nome: AstraZeneca Clinical Study Information Center
- Numero di telefono: 1-877-240-9479
- Email: information.center@astrazeneca.com
Luoghi di studio
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Beijing, Cina, 100029
- Research Site
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Bozhou, Cina, 236000
- Research Site
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Cangzhou, Cina, 061002
- Research Site
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Changzhou, Cina, 213004
- Research Site
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Chongqing, Cina, 402260
- Research Site
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Daqing, Cina, 163316
- Research Site
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Ganzhou, Cina, 341099
- Research Site
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Guangzhou, Cina, 510150
- Research Site
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Guangzhou, Cina, 510800
- Research Site
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Jiaxing, Cina, 314001
- Research Site
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Jinan, Cina, 250031
- Research Site
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Jinan, Cina, 250013
- Research Site
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Liuzhou, Cina, 545005
- Research Site
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Luoyang, Cina, 471003
- Research Site
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Luzhou, Cina, 646000
- Research Site
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Sanya, Cina, 572000
- Research Site
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Shanghai, Cina, 200031
- Research Site
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Shanghai, Cina, 310000
- Research Site
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Shanghai, Cina, 201700
- Research Site
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Shenyang, Cina, 110016
- Research Site
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Shenyang, Cina, 110023
- Research Site
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Shiyan, Cina, 442099
- Research Site
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Suzhou, Cina, 215004
- Research Site
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Wuhan, Cina, 430060
- Research Site
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Xi'an, Cina, 710068
- Research Site
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Xuancheng, Cina, 242000
- Research Site
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Yuncheng, Cina, 044099
- Research Site
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Zhengzhou, Cina, 450007
- Research Site
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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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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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. |
|
Sperimentale: 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. |
|
Comparatore placebo: 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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Percent change in body weight from baseline at Week 64
Lasso di tempo: 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
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Number of participants achieving at Least a 10% Reduction in Body Weight From Baseline at Week 64
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: From first administration through Week 64 and the 4-week safety follow-up
|
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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Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- D8750C00019
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano 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.
Periodo di condivisione 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.
Criteri di accesso alla condivisione 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 di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .