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A Study to Evaluate Effect of AZD6234 in Adult Participants With Type 2 Diabetes Mellitus and Obesity or Overweight (SELENE 2)

20 agosto 2026 aggiornato da: AstraZeneca

A Phase III Randomized, Double-Blind, Placebo-Controlled Multicentre Trial to Evaluate the Efficacy and Safety of AZD6234 in Participants With Type 2 Diabetes Mellitus and Obesity or Overweight (SELENE 2)

The study will evaluate how well AZD6234 works and how safe it is in adults with excess weight or obesity. Efficacy of AZD6234 will be compared to placebo in percent body weight change from baseline at 68 weeks of treatment

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

This is a Phase III, global, randomized, parallel-group, double-blind, multicentre study to assess the efficacy and safety of AZD6234 compared with placebo in adults with Type 2 Diabetes Mellitus (T2DM) and obesity or overweight. Eligible participants will be randomized to either receive AZD6234 or matching placebo respectively.

Tipo di studio

Interventistico

Iscrizione (Stimato)

1500

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Argentina
      • CABA, Argentina, C1120AAC
        • Research Site
      • CABA, Argentina, C1425HFA
        • Research Site
      • Ciudad de Buenos Aires, Argentina, C1094AAD
        • Research Site
      • Mendoza, Argentina, 5500
        • Research Site
      • Ramos Mejía, Argentina, B1704ETD
        • Research Site
      • Rosario, Argentina, S2000PBJ
        • Research Site
      • San Nicolás, Argentina, B2900DMH
        • Research Site
  • Australia
      • Botany, Australia, 2019
        • Research Site
      • Helensvale, Australia, 4212
        • Research Site
      • Kotara, Australia, 2289
        • Research Site
      • Malvern, Australia, 3144
        • Research Site
      • Maroubra, Australia, 2035
        • Research Site
      • Waitara, Australia, 2077
        • Research Site
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T3R 1W9
        • Research Site
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Y 3W2
        • Research Site
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1G 1A7
        • Research Site
    • Nova Scotia
      • Truro, Nova Scotia, Canada, B2N 1L2
        • Research Site
    • Ontario
      • Hamilton, Ontario, Canada, L8L 5G8
        • Research Site
      • Markham, Ontario, Canada, L3S 0A2
        • Research Site
      • North York, Ontario, Canada, M6B 3H7
        • Research Site
      • Sarnia, Ontario, Canada, N7T 4X3
        • Research Site
      • Scarborough Village, Ontario, Canada, M1R 0B1
        • Research Site
      • Stoney Creek, Ontario, Canada, L8J 3W2
        • Research Site
      • Stouffville, Ontario, Canada, L4A1H2
        • Research Site
      • Toronto, Ontario, Canada, M6G 1M2
        • Research Site
      • Toronto, Ontario, Canada, M4G3E8
        • Research Site
    • Quebec
      • Joliette, Quebec, Canada, J6E 6A9
        • Research Site
      • Montreal, Quebec, Canada, H4N 2W2
        • Research Site
      • Montreal, Quebec, Canada, H4J 1E3
        • Research Site
      • Québec, Quebec, Canada, G2J 0C4
        • Research Site
      • Trois-Rivières, Quebec, Canada, G9A 4P3
        • Research Site
  • Chile
      • Concepción, Chile, 4070196
        • Research Site
      • Concepción, Chile, 4070060
        • Research Site
      • Concepción, Chile, 4070566
        • Research Site
      • Iquique, Chile, 1111442
        • Research Site
      • Providencia, Chile, 7500504
        • Research Site
      • Santiago, Chile
        • Research Site
      • Santiago, Chile, 7691236
        • Research Site
      • Santiago, Chile, 8331143
        • Research Site
      • Santiago, Chile, 7510187
        • Research Site
  • Cina
      • Beijing, Cina, 100050
        • Research Site
      • Cangzhou, Cina, 061001
        • Research Site
      • Changchun, Cina, 130011
        • Research Site
      • Chengdu, Cina, 610072
        • Research Site
      • Chengdu, Cina, 610021
        • Research Site
      • Danyang, Cina, 212399
        • Research Site
      • Ganzhou, Cina, 341000
        • Research Site
      • Guangzhou, Cina, 510280
        • Research Site
      • Huizhou, Cina, 516002
        • Research Site
      • Huzhou, Cina, 313003
        • Research Site
      • Lanzhou, Cina, 730000
        • Research Site
      • Nanjing, Cina, 210009
        • Research Site
      • Nanjing, Cina, 210008
        • Research Site
      • Panjin, Cina, 124009
        • Research Site
      • Suzhou, Cina, 215006
        • Research Site
      • Xianyang, Cina, 712000
        • Research Site
  • Corea del Sud
      • Busan, Corea del Sud, 48108
        • Research Site
      • Daegu, Corea del Sud, 42601
        • Research Site
      • Daejeon, Corea del Sud, 35233
        • Research Site
      • Incheon, Corea del Sud, 403-720
        • Research Site
      • Seoul, Corea del Sud, 08308
        • Research Site
      • Seoul, Corea del Sud, 06351
        • Research Site
      • Seoul, Corea del Sud, 01830
        • Research Site
      • Seoul, Corea del Sud, 143729
        • Research Site
      • Seoul, Corea del Sud, 150-713
        • Research Site
      • Suwon, Corea del Sud, 16247
        • Research Site
  • Germania
      • Berlin, Germania, 10117
        • Research Site
      • Berlin, Germania, 10629
        • Research Site
      • Bochum, Germania, 44789
        • Research Site
      • Bünde, Germania, 32257
        • Research Site
      • Dresden, Germania, 01069
        • Research Site
      • Frankfurt, Germania, 60596
        • Research Site
      • Frankfurt, Germania, 60590
        • Research Site
      • Freiburg im Breisgau, Germania, 79106
        • Research Site
      • Göttingen, Germania, 37075
        • Research Site
      • Hamburg, Germania, 20253
        • Research Site
      • Hamburg, Germania, 20095
        • Research Site
      • Hanover, Germania, 30159
        • Research Site
      • Homburg, Germania, 66421
        • Research Site
      • Jerichow, Germania, 39319
        • Research Site
      • Karlsruhe, Germania, 76137
        • Research Site
      • Leipzig, Germania, 04177
        • Research Site
      • Magdeburg, Germania, 39110
        • Research Site
      • Mainz, Germania, 55128
        • Research Site
      • München, Germania, 80339
        • Research Site
      • Offenbach, Germania, 63065
        • Research Site
  • Giappone
      • Aira, Giappone, 899-5421
        • Research Site
      • Hachioji-shi, Giappone, 192-0071
        • Research Site
      • Izunokuni-shi, Giappone, 410-2295
        • Research Site
      • Kumamoto, Giappone, 860-0833
        • Research Site
      • Nagoya, Giappone, 451-8511
        • Research Site
      • Nagoya, Giappone, 467-0806
        • Research Site
      • Nerima-ku, Giappone, 177-0051
        • Research Site
      • Osaka, Giappone, 540-0006
        • Research Site
      • Osaka, Giappone, 537-0014
        • Research Site
      • Saga, Giappone, 840-8571
        • Research Site
      • Tanabe-shi, Giappone, 646-8558
        • Research Site
  • India
      • Bangalore, India, 560092
        • Research Site
      • Indore, India, 452010
        • Research Site
      • Kolkata, India, 700014
        • Research Site
      • Nagpur, India, 440010
        • Research Site
      • Pune, India, 411057
        • Research Site
      • Pune, India, 411021
        • Research Site
      • Siliguri, India, 734012
        • Research Site
      • Visakhapatnam, India, 530002
        • Research Site
  • Polonia
      • Bialystok, Polonia, 15-481
        • Research Site
      • Elblag, Polonia, 82-300
        • Research Site
      • Gdynia, Polonia, 81-338
        • Research Site
      • Katowice, Polonia, 40-081
        • Research Site
      • Katowice, Polonia, 40-772
        • Research Site
      • Krakow, Polonia, 31-271
        • Research Site
      • Krakow, Polonia, 30-105
        • Research Site
      • Legnica, Polonia, 59-220
        • Research Site
      • Lodz, Polonia, 90-338
        • Research Site
      • Lodz, Polonia, 90-132
        • Research Site
      • Poznan, Polonia, 60-354
        • Research Site
      • Radzionków, Polonia, 41-922
        • Research Site
      • Warsaw, Polonia, 03-291
        • Research Site
      • Warsaw, Polonia, 00-719
        • Research Site
      • Wroclaw, Polonia, 53-673
        • Research Site
  • Regno Unito
      • Chippenham, Regno Unito, SN15 2SB
        • Research Site
      • Corby, Regno Unito, NN17 2UR
        • Research Site
      • Corby, Regno Unito, NN18 9EZ
        • Research Site
      • Dunfermline, Regno Unito, KY12 0SU
        • Research Site
      • Hull, Regno Unito, HU3 2PA
        • Research Site
      • Northwood, Regno Unito, HA6 2RN
        • Research Site
  • Slovacchia
      • Bratislava, Slovacchia, 831 03
        • Research Site
      • Bratislava, Slovacchia, 83101
        • Research Site
      • Bratislava, Slovacchia, 83106
        • Research Site
      • Košice, Slovacchia, 040 01
        • Research Site
      • Košice, Slovacchia, 04022
        • Research Site
      • Lučenec, Slovacchia, 984 01
        • Research Site
      • Námestovo, Slovacchia, 02901
        • Research Site
      • Prievidza, Slovacchia, 97101
        • Research Site
      • Rožňava, Slovacchia, 048 01
        • Research Site
      • Trebišov, Slovacchia, 075 01
        • Research Site
  • Spagna
      • A Coruña, Spagna, 15006
        • Research Site
      • Alzira, Spagna, 46600
        • Research Site
      • Barcelona, Spagna, 08035
        • Research Site
      • Ferrol, Spagna, 15405
        • Research Site
      • Lleida, Spagna, 25198
        • Research Site
      • Málaga, Spagna, 29010
        • Research Site
      • Oviedo, Spagna, 33011
        • Research Site
      • Segovia, Spagna, 40002
        • Research Site
      • Seville, Spagna, 41010
        • Research Site
      • Seville, Spagna, 41950
        • Research Site
  • Stati Uniti
    • Alabama
      • Fairhope, Alabama, Stati Uniti, 36532
        • Research Site
      • Huntsville, Alabama, Stati Uniti, 35801
        • Research Site
    • Arizona
      • Mesa, Arizona, Stati Uniti, 85213
        • Research Site
      • Phoenix, Arizona, Stati Uniti, 85044
        • Research Site
      • Tucson, Arizona, Stati Uniti, 85715
        • Research Site
    • Arkansas
      • Little Rock, Arkansas, Stati Uniti, 72205
        • Research Site
    • California
      • Bakersfield, California, Stati Uniti, 93309
        • Research Site
      • Gardena, California, Stati Uniti, 90247
        • Research Site
      • Lincoln, California, Stati Uniti, 95648
        • Research Site
      • Torrance, California, Stati Uniti, 90503
        • Research Site
      • Walnut Creek, California, Stati Uniti, 94598
        • Research Site
    • Florida
      • Coral Gables, Florida, Stati Uniti, 33134
        • Research Site
      • Fleming Island, Florida, Stati Uniti, 32003
        • Research Site
      • Fort Lauderdale, Florida, Stati Uniti, 33316
        • Research Site
      • Ocoee, Florida, Stati Uniti, 34761
        • Research Site
    • Georgia
      • Woodstock, Georgia, Stati Uniti, 30189
        • Research Site
    • Illinois
      • Chicago, Illinois, Stati Uniti, 60640
        • Research Site
      • Melrose Park, Illinois, Stati Uniti, 60160
        • Research Site
    • Kansas
      • Lenexa, Kansas, Stati Uniti, 66219
        • Research Site
      • Newton, Kansas, Stati Uniti, 67114
        • Research Site
    • Louisiana
      • Monroe, Louisiana, Stati Uniti, 71201
        • Research Site
    • Maryland
      • Beltsville, Maryland, Stati Uniti, 20705
        • Research Site
      • Lanham, Maryland, Stati Uniti, 20706
        • Research Site
      • Oxon Hill, Maryland, Stati Uniti, 20745
        • Research Site
    • Massachusetts
      • North Dartmouth, Massachusetts, Stati Uniti, 02747
        • Research Site
    • Michigan
      • Farmington Hills, Michigan, Stati Uniti, 48336
        • Research Site
    • Mississippi
      • Fayette, Mississippi, Stati Uniti, 39069
        • Research Site
    • Missouri
      • Kansas City, Missouri, Stati Uniti, 64111
        • Research Site
      • St Louis, Missouri, Stati Uniti, 63141
        • Research Site
    • Nebraska
      • Omaha, Nebraska, Stati Uniti, 68114
        • Research Site
      • Omaha, Nebraska, Stati Uniti, 68144
        • Research Site
    • New Jersey
      • Eatontown, New Jersey, Stati Uniti, 07724
        • Research Site
      • Somerset, New Jersey, Stati Uniti, 08873
        • Research Site
      • Warren Township, New Jersey, Stati Uniti, 07059
        • Research Site
    • North Carolina
      • Greensboro, North Carolina, Stati Uniti, 27408
        • Research Site
      • Monroe, North Carolina, Stati Uniti, 28112
        • Research Site
    • Ohio
      • Munroe Falls, Ohio, Stati Uniti, 44262
        • Research Site
    • Pennsylvania
      • Scottdale, Pennsylvania, Stati Uniti, 15683
        • Research Site
    • Tennessee
      • Franklin, Tennessee, Stati Uniti, 37067
        • Research Site
      • Knoxville, Tennessee, Stati Uniti, 37938
        • Research Site
    • Texas
      • DeSoto, Texas, Stati Uniti, 75115
        • Research Site
      • El Paso, Texas, Stati Uniti, 79935
        • Research Site
      • Houston, Texas, Stati Uniti, 77099
        • Research Site
      • Midland, Texas, Stati Uniti, 79707
        • Research Site
      • Pasadena, Texas, Stati Uniti, 77504
        • Research Site
      • San Antonio, Texas, Stati Uniti, 78251
        • Research Site
      • San Antonio, Texas, Stati Uniti, 78215
        • Research Site
      • San Antonio, Texas, Stati Uniti, 78207
        • Research Site
    • Virginia
      • Manassas, Virginia, Stati Uniti, 20110
        • Research Site
      • Norfolk, Virginia, Stati Uniti, 23504
        • Research Site
  • Taiwan
      • Changhua, Taiwan, 500
        • Research Site
      • Kaohsiung City, Taiwan, 80756
        • Research Site
      • Taichung, Taiwan, 402
        • Research Site
      • Taichung, Taiwan, 404
        • Research Site
      • Taichung, Taiwan, 407219
        • Research Site
      • Taichung, Taiwan, 433004
        • Research Site
      • Tainan, Taiwan, 704
        • Research Site
      • Tainan, Taiwan, 710
        • Research Site
      • Taipei, Taiwan, 10002
        • Research Site
      • Taipei, Taiwan, 11490
        • Research Site
      • Zhubei, Taiwan, 302
        • Research Site
  • Ungheria
      • Balatonfüred, Ungheria, 8230
        • Research Site
      • Budapest, Ungheria, 1036
        • Research Site
      • Budapest, Ungheria, 1138
        • Research Site
      • Budapest, Ungheria, 1132
        • Research Site
      • Budapest, Ungheria, 1024
        • Research Site
      • Debrecen, Ungheria, 4032
        • Research Site
      • Debrecen, Ungheria, 4031
        • Research Site
      • Miskolc, Ungheria, 3530
        • Research Site
      • Nyíregyháza-Sóstóhegy, Ungheria, 4481
        • Research Site
      • Szeged, Ungheria, 6725
        • Research Site
      • Szolnok, Ungheria, 5000
        • Research Site

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • Males & females (inclusive of all gender identities) age ≥18 years
  • BMI ≥27 kg/m2
  • Diagnosed with T2DM ≥90 days prior to Screening
  • HbA1c value at Screening of ≥6.0% (42 mmol/mol) and ≤10% (86 mmol/mol) managed with diet and exercise alone or with a stable dose of any oral glycaemic-lowering agent (as per local labelling)
  • Stable body weight (≤5% body weight change) for at least 3 months prior to Randomisation
  • History of at least one self-reported unsuccessful attempt to lose body weight in lifetime

Exclusion Criteria:

  • Obesity primarily caused by other endocrine disorders
  • Type 1 diabetes mellitus (or any other diabetes mellitus that is not clearly Type 2 diabetes), OR have history of ketoacidosis or hyperosmolar coma/state within 3 months prior to Screening

  • Significant hepatobiliary disease and/or any of the following results at Screening:

    • ALT ≥ 3.0 X ULN
    • AST ≥ 3.0 X ULN
    • TBL > 1.5 X ULN (except for cases of known Gilbert's Syndrome)
  • Has received treatment with a GLP-1 receptor agonist or GLP-1 containing medication for any indication within 3 months before Randomisation
  • Use of insulin therapy for T2DM within 3 months prior to screening

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore placebo: Placebo
Placebo corrispondente
Droga: Placebo
Placebo matching IMP dose injected subcutaneously, once a week.
Sperimentale: AZD6234 Dose 1
Droga: AZD6234
IMP injected subcutaneously, once a week. Unit dose strength as per CSP.
Sperimentale: AZD6234 Dose 2
Droga: AZD6234
IMP injected subcutaneously, once a week. Unit dose strength as per CSP.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percent change in body weight from baseline at 68 weeks of treatment.
Lasso di tempo: 68 weeks
To evaluate the effect of AZD6234 compared to placebo in percent body weight change
68 weeks

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Absolute change in weight (kg) from baseline at 68 weeks of treatment
Lasso di tempo: 68 weeks
To evaluate the effect of AZD6234 compared to placebo on absolute change in weight
68 weeks
Achievement of at least 5 % body weight loss from baseline at 68 weeks of treatment
Lasso di tempo: 68 weeks
To evaluate the effect of AZD6234 compared to placebo in body weight loss of at least 5%
68 weeks
Achievement of at least 10 % body weight loss from baseline at 68 weeks of treatment
Lasso di tempo: 68 weeks
To evaluate the effect of AZD6234 compared to placebo in body weight loss of at least 10%
68 weeks
Change in haemoglobin A1C from baseline at 68 weeks of treatment
Lasso di tempo: 68 weeks
To evaluate the effect of AZD6234 on haemoglobin A1C change
68 weeks
Change in waist circumference (cm) from baseline at 68 weeks of treatment
Lasso di tempo: 68 weeks
To evaluate the effect of AZD6234 compared to placebo on waist circumference change
68 weeks
Percent change in triglycerides from baseline at 68 weeks of treatment
Lasso di tempo: 68 weeks
To evaluate the effect of AZD6234 compared to placebo on triglycerides percent change
68 weeks
Change in systolic blood pressure (mmHg) from baseline at 68 weeks of treatment
Lasso di tempo: 68 weeks
To evaluate the effect of AZD6234 compared to placebo on systolic blood pressure change
68 weeks
Percent change in fat mass from baseline at 68 weeks of treatment measured by DXA in the DXA Sub-Study subset
Lasso di tempo: 68 weeks
Body Composition Sub-study: To evaluate the effect of AZD6234 compared to placebo on body composition change in the DXA subset of participants
68 weeks

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

AstraZeneca

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

21 agosto 2026

Completamento primario (Stimato)

9 agosto 2028

Completamento dello studio (Stimato)

9 agosto 2028

Date di iscrizione allo studio

Primo inviato

6 agosto 2026

Primo inviato che soddisfa i criteri di controllo qualità

20 agosto 2026

Primo Inserito (Effettivo)

25 agosto 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

25 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

20 agosto 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • D8750C00012
  • 2025 (Sovvenzione/contratto NIH degli Stati Uniti: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • 159494 (Identificatore di registro: IND Number)
  • 2025-524616-11-00 (Ctis)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

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

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

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 .

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