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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. august 2026 opdateret af: 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

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

1500

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • 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
  • Australien
      • Botany, Australien, 2019
        • Research Site
      • Helensvale, Australien, 4212
        • Research Site
      • Kotara, Australien, 2289
        • Research Site
      • Malvern, Australien, 3144
        • Research Site
      • Maroubra, Australien, 2035
        • Research Site
      • Waitara, Australien, 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
  • Det Forenede Kongerige
      • Chippenham, Det Forenede Kongerige, SN15 2SB
        • Research Site
      • Corby, Det Forenede Kongerige, NN17 2UR
        • Research Site
      • Corby, Det Forenede Kongerige, NN18 9EZ
        • Research Site
      • Dunfermline, Det Forenede Kongerige, KY12 0SU
        • Research Site
      • Hull, Det Forenede Kongerige, HU3 2PA
        • Research Site
      • Northwood, Det Forenede Kongerige, HA6 2RN
        • Research Site
  • Forenede Stater
    • Alabama
      • Fairhope, Alabama, Forenede Stater, 36532
        • Research Site
      • Huntsville, Alabama, Forenede Stater, 35801
        • Research Site
    • Arizona
      • Mesa, Arizona, Forenede Stater, 85213
        • Research Site
      • Phoenix, Arizona, Forenede Stater, 85044
        • Research Site
      • Tucson, Arizona, Forenede Stater, 85715
        • Research Site
    • Arkansas
      • Little Rock, Arkansas, Forenede Stater, 72205
        • Research Site
    • California
      • Bakersfield, California, Forenede Stater, 93309
        • Research Site
      • Gardena, California, Forenede Stater, 90247
        • Research Site
      • Lincoln, California, Forenede Stater, 95648
        • Research Site
      • Torrance, California, Forenede Stater, 90503
        • Research Site
      • Walnut Creek, California, Forenede Stater, 94598
        • Research Site
    • Florida
      • Coral Gables, Florida, Forenede Stater, 33134
        • Research Site
      • Fleming Island, Florida, Forenede Stater, 32003
        • Research Site
      • Fort Lauderdale, Florida, Forenede Stater, 33316
        • Research Site
      • Ocoee, Florida, Forenede Stater, 34761
        • Research Site
    • Georgia
      • Woodstock, Georgia, Forenede Stater, 30189
        • Research Site
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60640
        • Research Site
      • Melrose Park, Illinois, Forenede Stater, 60160
        • Research Site
    • Kansas
      • Lenexa, Kansas, Forenede Stater, 66219
        • Research Site
      • Newton, Kansas, Forenede Stater, 67114
        • Research Site
    • Louisiana
      • Monroe, Louisiana, Forenede Stater, 71201
        • Research Site
    • Maryland
      • Beltsville, Maryland, Forenede Stater, 20705
        • Research Site
      • Lanham, Maryland, Forenede Stater, 20706
        • Research Site
      • Oxon Hill, Maryland, Forenede Stater, 20745
        • Research Site
    • Massachusetts
      • North Dartmouth, Massachusetts, Forenede Stater, 02747
        • Research Site
    • Michigan
      • Farmington Hills, Michigan, Forenede Stater, 48336
        • Research Site
    • Mississippi
      • Fayette, Mississippi, Forenede Stater, 39069
        • Research Site
    • Missouri
      • Kansas City, Missouri, Forenede Stater, 64111
        • Research Site
      • St Louis, Missouri, Forenede Stater, 63141
        • Research Site
    • Nebraska
      • Omaha, Nebraska, Forenede Stater, 68114
        • Research Site
      • Omaha, Nebraska, Forenede Stater, 68144
        • Research Site
    • New Jersey
      • Eatontown, New Jersey, Forenede Stater, 07724
        • Research Site
      • Somerset, New Jersey, Forenede Stater, 08873
        • Research Site
      • Warren Township, New Jersey, Forenede Stater, 07059
        • Research Site
    • North Carolina
      • Greensboro, North Carolina, Forenede Stater, 27408
        • Research Site
      • Monroe, North Carolina, Forenede Stater, 28112
        • Research Site
    • Ohio
      • Munroe Falls, Ohio, Forenede Stater, 44262
        • Research Site
    • Pennsylvania
      • Scottdale, Pennsylvania, Forenede Stater, 15683
        • Research Site
    • Tennessee
      • Franklin, Tennessee, Forenede Stater, 37067
        • Research Site
      • Knoxville, Tennessee, Forenede Stater, 37938
        • Research Site
    • Texas
      • DeSoto, Texas, Forenede Stater, 75115
        • Research Site
      • El Paso, Texas, Forenede Stater, 79935
        • Research Site
      • Houston, Texas, Forenede Stater, 77099
        • Research Site
      • Midland, Texas, Forenede Stater, 79707
        • Research Site
      • Pasadena, Texas, Forenede Stater, 77504
        • Research Site
      • San Antonio, Texas, Forenede Stater, 78251
        • Research Site
      • San Antonio, Texas, Forenede Stater, 78215
        • Research Site
      • San Antonio, Texas, Forenede Stater, 78207
        • Research Site
    • Virginia
      • Manassas, Virginia, Forenede Stater, 20110
        • Research Site
      • Norfolk, Virginia, Forenede Stater, 23504
        • Research Site
  • Indien
      • Bangalore, Indien, 560092
        • Research Site
      • Indore, Indien, 452010
        • Research Site
      • Kolkata, Indien, 700014
        • Research Site
      • Nagpur, Indien, 440010
        • Research Site
      • Pune, Indien, 411057
        • Research Site
      • Pune, Indien, 411021
        • Research Site
      • Siliguri, Indien, 734012
        • Research Site
      • Visakhapatnam, Indien, 530002
        • Research Site
  • Japan
      • Aira, Japan, 899-5421
        • Research Site
      • Hachioji-shi, Japan, 192-0071
        • Research Site
      • Izunokuni-shi, Japan, 410-2295
        • Research Site
      • Kumamoto, Japan, 860-0833
        • Research Site
      • Nagoya, Japan, 451-8511
        • Research Site
      • Nagoya, Japan, 467-0806
        • Research Site
      • Nerima-ku, Japan, 177-0051
        • Research Site
      • Osaka, Japan, 540-0006
        • Research Site
      • Osaka, Japan, 537-0014
        • Research Site
      • Saga, Japan, 840-8571
        • Research Site
      • Tanabe-shi, Japan, 646-8558
        • Research Site
  • Kina
      • Beijing, Kina, 100050
        • Research Site
      • Cangzhou, Kina, 061001
        • Research Site
      • Changchun, Kina, 130011
        • Research Site
      • Chengdu, Kina, 610072
        • Research Site
      • Chengdu, Kina, 610021
        • Research Site
      • Danyang, Kina, 212399
        • Research Site
      • Ganzhou, Kina, 341000
        • Research Site
      • Guangzhou, Kina, 510280
        • Research Site
      • Huizhou, Kina, 516002
        • Research Site
      • Huzhou, Kina, 313003
        • Research Site
      • Lanzhou, Kina, 730000
        • Research Site
      • Nanjing, Kina, 210009
        • Research Site
      • Nanjing, Kina, 210008
        • Research Site
      • Panjin, Kina, 124009
        • Research Site
      • Suzhou, Kina, 215006
        • Research Site
      • Xianyang, Kina, 712000
        • Research Site
  • Polen
      • Bialystok, Polen, 15-481
        • Research Site
      • Elblag, Polen, 82-300
        • Research Site
      • Gdynia, Polen, 81-338
        • Research Site
      • Katowice, Polen, 40-081
        • Research Site
      • Katowice, Polen, 40-772
        • Research Site
      • Krakow, Polen, 31-271
        • Research Site
      • Krakow, Polen, 30-105
        • Research Site
      • Legnica, Polen, 59-220
        • Research Site
      • Lodz, Polen, 90-338
        • Research Site
      • Lodz, Polen, 90-132
        • Research Site
      • Poznan, Polen, 60-354
        • Research Site
      • Radzionków, Polen, 41-922
        • Research Site
      • Warsaw, Polen, 03-291
        • Research Site
      • Warsaw, Polen, 00-719
        • Research Site
      • Wroclaw, Polen, 53-673
        • Research Site
  • Slovakiet
      • Bratislava, Slovakiet, 831 03
        • Research Site
      • Bratislava, Slovakiet, 83101
        • Research Site
      • Bratislava, Slovakiet, 83106
        • Research Site
      • Košice, Slovakiet, 040 01
        • Research Site
      • Košice, Slovakiet, 04022
        • Research Site
      • Lučenec, Slovakiet, 984 01
        • Research Site
      • Námestovo, Slovakiet, 02901
        • Research Site
      • Prievidza, Slovakiet, 97101
        • Research Site
      • Rožňava, Slovakiet, 048 01
        • Research Site
      • Trebišov, Slovakiet, 075 01
        • Research Site
  • Spanien
      • A Coruña, Spanien, 15006
        • Research Site
      • Alzira, Spanien, 46600
        • Research Site
      • Barcelona, Spanien, 08035
        • Research Site
      • Ferrol, Spanien, 15405
        • Research Site
      • Lleida, Spanien, 25198
        • Research Site
      • Málaga, Spanien, 29010
        • Research Site
      • Oviedo, Spanien, 33011
        • Research Site
      • Segovia, Spanien, 40002
        • Research Site
      • Seville, Spanien, 41010
        • Research Site
      • Seville, Spanien, 41950
        • Research Site
  • Sydkorea
      • Busan, Sydkorea, 48108
        • Research Site
      • Daegu, Sydkorea, 42601
        • Research Site
      • Daejeon, Sydkorea, 35233
        • Research Site
      • Incheon, Sydkorea, 403-720
        • Research Site
      • Seoul, Sydkorea, 08308
        • Research Site
      • Seoul, Sydkorea, 06351
        • Research Site
      • Seoul, Sydkorea, 01830
        • Research Site
      • Seoul, Sydkorea, 143729
        • Research Site
      • Seoul, Sydkorea, 150-713
        • Research Site
      • Suwon, Sydkorea, 16247
        • 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
  • Tyskland
      • Berlin, Tyskland, 10117
        • Research Site
      • Berlin, Tyskland, 10629
        • Research Site
      • Bochum, Tyskland, 44789
        • Research Site
      • Bünde, Tyskland, 32257
        • Research Site
      • Dresden, Tyskland, 01069
        • Research Site
      • Frankfurt, Tyskland, 60596
        • Research Site
      • Frankfurt, Tyskland, 60590
        • Research Site
      • Freiburg im Breisgau, Tyskland, 79106
        • Research Site
      • Göttingen, Tyskland, 37075
        • Research Site
      • Hamburg, Tyskland, 20253
        • Research Site
      • Hamburg, Tyskland, 20095
        • Research Site
      • Hanover, Tyskland, 30159
        • Research Site
      • Homburg, Tyskland, 66421
        • Research Site
      • Jerichow, Tyskland, 39319
        • Research Site
      • Karlsruhe, Tyskland, 76137
        • Research Site
      • Leipzig, Tyskland, 04177
        • Research Site
      • Magdeburg, Tyskland, 39110
        • Research Site
      • Mainz, Tyskland, 55128
        • Research Site
      • München, Tyskland, 80339
        • Research Site
      • Offenbach, Tyskland, 63065
        • Research Site
  • Ungarn
      • Balatonfüred, Ungarn, 8230
        • Research Site
      • Budapest, Ungarn, 1036
        • Research Site
      • Budapest, Ungarn, 1138
        • Research Site
      • Budapest, Ungarn, 1132
        • Research Site
      • Budapest, Ungarn, 1024
        • Research Site
      • Debrecen, Ungarn, 4032
        • Research Site
      • Debrecen, Ungarn, 4031
        • Research Site
      • Miskolc, Ungarn, 3530
        • Research Site
      • Nyíregyháza-Sóstóhegy, Ungarn, 4481
        • Research Site
      • Szeged, Ungarn, 6725
        • Research Site
      • Szolnok, Ungarn, 5000
        • Research Site

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Placebo
Matchende placebo
Medicin: Placebo
Placebo matching IMP dose injected subcutaneously, once a week.
Eksperimentel: AZD6234 Dose 1
Medicin: AZD6234
IMP injected subcutaneously, once a week. Unit dose strength as per CSP.
Eksperimentel: AZD6234 Dose 2
Medicin: AZD6234
IMP injected subcutaneously, once a week. Unit dose strength as per CSP.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percent change in body weight from baseline at 68 weeks of treatment.
Tidsramme: 68 weeks
To evaluate the effect of AZD6234 compared to placebo in percent body weight change
68 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Absolute change in weight (kg) from baseline at 68 weeks of treatment
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

AstraZeneca

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

21. august 2026

Primær færdiggørelse (Anslået)

9. august 2028

Studieafslutning (Anslået)

9. august 2028

Datoer for studieregistrering

Først indsendt

6. august 2026

Først indsendt, der opfyldte QC-kriterier

20. august 2026

Først opslået (Faktiske)

25. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

25. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • D8750C00012
  • 2025 (U.S. NIH-bevilling/kontrakt: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • 159494 (Registry Identifier: IND Number)
  • 2025-524616-11-00 (Ctis)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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.

IPD-delingstidsramme

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.

IPD-delingsadgangskriterier

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.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner