A Study to Evaluate Effect of AZD6234 as an Adjunct to Incretin-based Therapies in Adult Participants With Obesity or Overweight With Weight-related Comorbidity With or Without Type 2 Diabetes Mellitus (SELENE 3)
8. september 2026 opdateret af: AstraZeneca
A Phase III Randomised, Double-Blind, Placebo-Controlled Multicentre Trial to Evaluate the Efficacy and Safety of AZD6234 as an Adjunct to Incretin-based Therapies in Participants With Obesity or Overweight With at Least One Weight-Related Comorbidity With or Without Type 2 Diabetes Mellitus (SELENE 3)
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
Rekruttering
Intervention / Behandling
Detaljeret beskrivelse
This is a Phase III, global, randomised, parallel-group, double-blind, multicentre study to assess the efficacy and safety of AZD6234 as an adjunct to incretin-based therapies, compared with placebo in adults with obesity or overweight with at least one weight-related comorbidity and with or without Type 2 Diabetes Mellitus (T2DM).
Eligible participants will be randomised to either receive AZD6234 or matching placebo respectively.
Study treatment (AZD6234 or placebo) will be added on to the participant's stable dose of background incretin-based therapies.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
500
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: AstraZeneca Clinical Study Information Center
- Telefonnummer: 1-877-240-9479
- E-mail: information.center@astrazeneca.com
Studiesteder
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Buenos Aires, Argentina, C1120AAC
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CABA, Argentina, C1425HFA
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Ciudad de Buenos Aires, Argentina, C1094AAD
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Ramos Mejía, Argentina, B1704ETD
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Rosario, Argentina, S2000PBJ
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San Nicolás, Argentina, B2900DMH
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Belo Horizonte, Brasilien, 30150-320
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Campinas, Brasilien, 13060-080
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Campinas, Brasilien, 13060-803
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São Paulo, Brasilien, 01236-030
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São Paulo, Brasilien, 04266-010
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São Paulo, Brasilien, 04039-002
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Alberta
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Calgary, Alberta, Canada, T2V 4J2
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Calgary, Alberta, Canada, T3R 1W9
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British Columbia
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Surrey, British Columbia, Canada, V3T 4G8
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Vancouver, British Columbia, Canada, V5Y 3W2
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Ontario
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Guelph, Ontario, Canada, N1H 1B1
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Hamilton, Ontario, Canada, L8L 5G8
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Stouffville, Ontario, Canada, L4A1H2
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Toronto, Ontario, Canada, M4G3E8
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Quebec
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Joliette, Quebec, Canada, J6E 6A9
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Montreal, Quebec, Canada, H4J 1E3
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Aarhus N, Danmark, 8200
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Gandrup, Danmark, 9362
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Herlev, Danmark, 2730
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Herlev, Danmark, 2730
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Holbæk, Danmark, 4300
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Hvidovre, Danmark, 2650
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Middelfart, Danmark, 5500
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Odense, Danmark, 5000
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Vejle, Danmark, 7100
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Airdrie, Det Forenede Kongerige, ML6 0JS
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Chippenham, Det Forenede Kongerige, SN14 6GT
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Hull, Det Forenede Kongerige, HU3 2PA
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Llandough, Det Forenede Kongerige, CF64 2XX
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Rotherham, Det Forenede Kongerige, S65 1DA
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California
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Escondido, California, Forenede Stater, 92025
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Lincoln, California, Forenede Stater, 95648
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Walnut Creek, California, Forenede Stater, 94598
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Florida
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Fleming Island, Florida, Forenede Stater, 32003
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Jacksonville, Florida, Forenede Stater, 32205
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Georgia
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Stockbridge, Georgia, Forenede Stater, 30281
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Woodstock, Georgia, Forenede Stater, 30189
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Illinois
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Champaign, Illinois, Forenede Stater, 61822
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Chicago, Illinois, Forenede Stater, 60640
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Maryland
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Beltsville, Maryland, Forenede Stater, 20705
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Oxon Hill, Maryland, Forenede Stater, 20745
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Missouri
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Kansas City, Missouri, Forenede Stater, 64111
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89101
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New Jersey
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Somerset, New Jersey, Forenede Stater, 08873
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North Carolina
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Statesville, North Carolina, Forenede Stater, 28625
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North Dakota
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Fargo, North Dakota, Forenede Stater, 58104
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Ohio
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Columbus, Ohio, Forenede Stater, 43215
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Portland, Oregon, Forenede Stater, 97202
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Pennsylvania
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Smithfield, Pennsylvania, Forenede Stater, 15478
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Tennessee
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Franklin, Tennessee, Forenede Stater, 37067
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Texas
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Houston, Texas, Forenede Stater, 77043
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Virginia
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Manassas, Virginia, Forenede Stater, 20110
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Washington
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Renton, Washington, Forenede Stater, 98057
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Holon, Israel, 5822012
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Jerusalem, Israel, 91120
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Kfar Saba, Israel, 4428164
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Petah Tikva, Israel, 49100
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Petah Tikva, Israel, 4937211
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Tel Aviv, Israel, 64239
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Chūōku, Japan, 103-0002
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Ichinomiya-shi, Japan, 491-8558
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Izunokuni-shi, Japan, 410-2295
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Kamakura-shi, Japan, 247-0056
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Kawagoe-shi, Japan, 350-0851
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Kitakyushu-shi, Japan, 802-0077
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Kyoto, Japan, 612-8555
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Kyoto, Japan, 607-8062
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Mito, Japan, 311-4153
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Nishinomiya-shi, Japan, 662-0971
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Yokohama, Japan, 230-8765
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Ōmihachiman, Japan, 523-0082
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Beijing, Kina, 100034
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Changchun, Kina, 130041
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Chengdu, Kina, 610072
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Chengdu, Kina, 611130
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Guangzhou, Kina, 510280
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Huzhou, Kina, 313003
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Nanjing, Kina, 210008
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Nanjing, Kina, 210009
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Ningbo, Kina, 315000
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Linköping, Sverige, 58213
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Lund, Sverige, 222 22
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Mölndal, Sverige, 43153
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Stockholm, Sverige, 113 61
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Örebro, Sverige, 703 62
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Ankara, Tyrkiet (Türkiye), 06100
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Ankara, Tyrkiet (Türkiye), 06800
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Antalya, Tyrkiet (Türkiye), 07059
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Center, Tyrkiet (Türkiye), 23200
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Istanbul, Tyrkiet (Türkiye), 34384
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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 ≥ 30 kg/m2 OR BMI ≥ 27 kg/m2 with at least one of the following weight-related comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea, cardiovascular disease, heart failure, chronic kidney disease, metabolic dysfunction associated steatotic liver disease, osteoarthritis of the knee, or stress urinary incontinence
For participants with T2DM only:
- Diagnosed with T2DM ≥ 90 days prior to Screening
- HbA1c value at Screening of ≥6.0% (42 mmol/mol) and ≤9.0% (75 mmol/mol) managed with diet and exercise alone or with a stable dose of any oral glycaemic-lowering agent and/or incretin-based medication
- Receiving a stable dose of incretin- based medications at a dose level that is sufficient for chronic weight management for at least 3 months prior to Screening and Randomisation.
- Stable body weight (≤ 3% 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 their lifetime
Exclusion Criteria:
- Obesity primarily caused by other endocrine disorders
- Type 1 diabetes mellitus
Significant hepatobiliary disease and/or any of the following results at Screening:
- ALT ≥ 3.0 × ULN
- AST ≥ 3.0 × ULN
- TBL > 1.5 × ULN (except for cases of known Gilbert's Syndrome)
- 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
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Placebo matching IMP dose injected subcutaneously, once a week.
|
|
Eksperimentel: AZD6234
|
IMP injected subcutaneously, once a week.
|
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 as compared to placebo as an adjunct to incretin-based therapies in percent body weight change
|
68 weeks
|
Sekundære 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 as compared to placebo as an adjunct to incretin-based therapies in percent body weight change in the T2DM and non-T2DM sub-populations separately
|
68 weeks
|
|
Absolute change in weight (kg) from baseline at 68 weeks of treatment
Tidsramme: 68 weeks
|
To evaluate the effect of AZD6234 as compared to placebo as an adjunct to incretin-based therapies on the absolute change in weight in the full population and in the T2DM and non-T2DM sub-populations separately
|
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 as compared to placebo as an adjunct to incretin-based therapies in body weight loss of at least 5% in the full population and in the T2DM and non T2DM sub-populations separately
|
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 as compared to placebo as an adjunct to incretin-based therapies in body weight loss of at least 10% in the full population and in the T2DM and non T2DM sub-populations separately
|
68 weeks
|
|
Change in waist circumference (cm) from baseline at 68 weeks of treatment
Tidsramme: 68 weeks
|
To evaluate whether AZD6234 as an adjunct to incretin-based therapies on the waist circumference in the full population and in the T2DM and non-T2DM sub-populations separately
|
68 weeks
|
|
Percent change in triglycerides from baseline at 68 weeks of treatment
Tidsramme: 68 weeks
|
To evaluate the effect of AZD6234 as compared to placebo as an adjunct to incretin-based therapies 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 as compared to placebo as an adjunct to incretin-based therapies on the systolic blood pressure change
|
68 weeks
|
|
Change in HbA1c from baseline at 68 weeks of treatment
Tidsramme: 68 weeks
|
For participants with T2DM only: to evaluate the effect of AZD6234 as an adjunct to incretin-based therapies on HbA1c change in the T2DM sub population only
|
68 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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 (Faktiske)
24. august 2026
Primær færdiggørelse (Anslået)
9. august 2028
Studieafslutning (Anslået)
9. august 2028
Datoer for studieregistrering
Først indsendt
10. august 2026
Først indsendt, der opfyldte QC-kriterier
17. august 2026
Først opslået (Faktiske)
20. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
10. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. september 2026
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- D8750C00011
- 2025 (U.S. NIH-bevilling/kontrakt: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
- 2025-523295-23-00 (Ctis)
- 159494 (Registry Identifier: IND Number)
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 .