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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 oppdatert av: 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

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Antatt)

1500

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

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
  • 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
  • Forente stater
    • Alabama
      • Fairhope, Alabama, Forente stater, 36532
        • Research Site
      • Huntsville, Alabama, Forente stater, 35801
        • Research Site
    • Arizona
      • Mesa, Arizona, Forente stater, 85213
        • Research Site
      • Phoenix, Arizona, Forente stater, 85044
        • Research Site
      • Tucson, Arizona, Forente stater, 85715
        • Research Site
    • Arkansas
      • Little Rock, Arkansas, Forente stater, 72205
        • Research Site
    • California
      • Bakersfield, California, Forente stater, 93309
        • Research Site
      • Gardena, California, Forente stater, 90247
        • Research Site
      • Lincoln, California, Forente stater, 95648
        • Research Site
      • Torrance, California, Forente stater, 90503
        • Research Site
      • Walnut Creek, California, Forente stater, 94598
        • Research Site
    • Florida
      • Coral Gables, Florida, Forente stater, 33134
        • Research Site
      • Fleming Island, Florida, Forente stater, 32003
        • Research Site
      • Fort Lauderdale, Florida, Forente stater, 33316
        • Research Site
      • Ocoee, Florida, Forente stater, 34761
        • Research Site
    • Georgia
      • Woodstock, Georgia, Forente stater, 30189
        • Research Site
    • Illinois
      • Chicago, Illinois, Forente stater, 60640
        • Research Site
      • Melrose Park, Illinois, Forente stater, 60160
        • Research Site
    • Kansas
      • Lenexa, Kansas, Forente stater, 66219
        • Research Site
      • Newton, Kansas, Forente stater, 67114
        • Research Site
    • Louisiana
      • Monroe, Louisiana, Forente stater, 71201
        • Research Site
    • Maryland
      • Beltsville, Maryland, Forente stater, 20705
        • Research Site
      • Lanham, Maryland, Forente stater, 20706
        • Research Site
      • Oxon Hill, Maryland, Forente stater, 20745
        • Research Site
    • Massachusetts
      • North Dartmouth, Massachusetts, Forente stater, 02747
        • Research Site
    • Michigan
      • Farmington Hills, Michigan, Forente stater, 48336
        • Research Site
    • Mississippi
      • Fayette, Mississippi, Forente stater, 39069
        • Research Site
    • Missouri
      • Kansas City, Missouri, Forente stater, 64111
        • Research Site
      • St Louis, Missouri, Forente stater, 63141
        • Research Site
    • Nebraska
      • Omaha, Nebraska, Forente stater, 68114
        • Research Site
      • Omaha, Nebraska, Forente stater, 68144
        • Research Site
    • New Jersey
      • Eatontown, New Jersey, Forente stater, 07724
        • Research Site
      • Somerset, New Jersey, Forente stater, 08873
        • Research Site
      • Warren Township, New Jersey, Forente stater, 07059
        • Research Site
    • North Carolina
      • Greensboro, North Carolina, Forente stater, 27408
        • Research Site
      • Monroe, North Carolina, Forente stater, 28112
        • Research Site
    • Ohio
      • Munroe Falls, Ohio, Forente stater, 44262
        • Research Site
    • Pennsylvania
      • Scottdale, Pennsylvania, Forente stater, 15683
        • Research Site
    • Tennessee
      • Franklin, Tennessee, Forente stater, 37067
        • Research Site
      • Knoxville, Tennessee, Forente stater, 37938
        • Research Site
    • Texas
      • DeSoto, Texas, Forente stater, 75115
        • Research Site
      • El Paso, Texas, Forente stater, 79935
        • Research Site
      • Houston, Texas, Forente stater, 77099
        • Research Site
      • Midland, Texas, Forente stater, 79707
        • Research Site
      • Pasadena, Texas, Forente stater, 77504
        • Research Site
      • San Antonio, Texas, Forente stater, 78251
        • Research Site
      • San Antonio, Texas, Forente stater, 78215
        • Research Site
      • San Antonio, Texas, Forente stater, 78207
        • Research Site
    • Virginia
      • Manassas, Virginia, Forente stater, 20110
        • Research Site
      • Norfolk, Virginia, Forente stater, 23504
        • 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
  • 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
  • Slovakia
      • Bratislava, Slovakia, 831 03
        • Research Site
      • Bratislava, Slovakia, 83101
        • Research Site
      • Bratislava, Slovakia, 83106
        • Research Site
      • Košice, Slovakia, 040 01
        • Research Site
      • Košice, Slovakia, 04022
        • Research Site
      • Lučenec, Slovakia, 984 01
        • Research Site
      • Námestovo, Slovakia, 02901
        • Research Site
      • Prievidza, Slovakia, 97101
        • Research Site
      • Rožňava, Slovakia, 048 01
        • Research Site
      • Trebišov, Slovakia, 075 01
        • Research Site
  • Spania
      • A Coruña, Spania, 15006
        • Research Site
      • Alzira, Spania, 46600
        • Research Site
      • Barcelona, Spania, 08035
        • Research Site
      • Ferrol, Spania, 15405
        • Research Site
      • Lleida, Spania, 25198
        • Research Site
      • Málaga, Spania, 29010
        • Research Site
      • Oviedo, Spania, 33011
        • Research Site
      • Segovia, Spania, 40002
        • Research Site
      • Seville, Spania, 41010
        • Research Site
      • Seville, Spania, 41950
        • Research Site
  • Storbritannia
      • Chippenham, Storbritannia, SN15 2SB
        • Research Site
      • Corby, Storbritannia, NN17 2UR
        • Research Site
      • Corby, Storbritannia, NN18 9EZ
        • Research Site
      • Dunfermline, Storbritannia, KY12 0SU
        • Research Site
      • Hull, Storbritannia, HU3 2PA
        • Research Site
      • Northwood, Storbritannia, HA6 2RN
        • Research Site
  • Sør -Korea
      • Busan, Sør -Korea, 48108
        • Research Site
      • Daegu, Sør -Korea, 42601
        • Research Site
      • Daejeon, Sør -Korea, 35233
        • Research Site
      • Incheon, Sør -Korea, 403-720
        • Research Site
      • Seoul, Sør -Korea, 08308
        • Research Site
      • Seoul, Sør -Korea, 06351
        • Research Site
      • Seoul, Sør -Korea, 01830
        • Research Site
      • Seoul, Sør -Korea, 143729
        • Research Site
      • Seoul, Sør -Korea, 150-713
        • Research Site
      • Suwon, Sør -Korea, 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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Placebo komparator: Placebo
Matchende placebo
Legemiddel: Placebo
Placebo matching IMP dose injected subcutaneously, once a week.
Eksperimentell: AZD6234 Dose 1
Legemiddel: AZD6234
IMP injected subcutaneously, once a week. Unit dose strength as per CSP.
Eksperimentell: AZD6234 Dose 2
Legemiddel: AZD6234
IMP injected subcutaneously, once a week. Unit dose strength as per CSP.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

AstraZeneca

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

21. august 2026

Primær fullføring (Antatt)

9. august 2028

Studiet fullført (Antatt)

9. august 2028

Datoer for studieregistrering

Først innsendt

6. august 2026

Først innsendt som oppfylte QC-kriteriene

20. august 2026

Først lagt ut (Faktiske)

25. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

25. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

20. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (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.

Tilgangskriterier for IPD-deling

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 Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere