A Phase III Study to Investigate the Efficacy and Safety of Elecoglipron Alone or in Combination With Dapagliflozin Compared With Placebo in Adults With Type 2 Diabetes Mellitus (Eluminate-1)
18. juni 2026 opdateret af: AstraZeneca
A Randomized, Double-blind, Parallel-group Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Elecoglipron Alone or in Combination With Dapagliflozin Compared With Placebo in Adults With Type 2 Diabetes Mellitus (Eluminate-1)
The purpose of this study is to evaluate the efficacy, safety, and tolerability of elecoglipron alone or in combination with dapagliflozin compared with placebo in adults with type 2 diabetes mellitus (T2DM) inadequately managed with lifestyle management alone or treated with other background glucose-lowering medication.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
800
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, C1425AGC
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CABA, Argentina, C1120AAC
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Caba, Argentina, C1128AAF
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Ciudad de Buenos Aires, Argentina, C1094AAD
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Mar del Plata, Argentina, B7600GNY
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San Nicolás, Argentina, B2900DMH
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San Vicente, Argentina, 5006
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Santa Fe, Argentina, S3000FWO
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Gandrup, Danmark, 9362
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Herlev, Danmark, 2730
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Hillerød, Danmark, 3400
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Hvidovre, Danmark, 2650
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Alabama
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Birmingham, Alabama, Forenede Stater, 35233
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Daphne, Alabama, Forenede Stater, 36526
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California
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Lomita, California, Forenede Stater, 90717
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Los Alamitos, California, Forenede Stater, 90720
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San Diego, California, Forenede Stater, 92111
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Walnut Creek, California, Forenede Stater, 94598
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Colorado
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Englewood, Colorado, Forenede Stater, 80110
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Connecticut
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Bridgeport, Connecticut, Forenede Stater, 06606
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Florida
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Jacksonville, Florida, Forenede Stater, 32256
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Orlando, Florida, Forenede Stater, 32801
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Georgia
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Conyers, Georgia, Forenede Stater, 30094
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Decatur, Georgia, Forenede Stater, 30030
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Hinesville, Georgia, Forenede Stater, 31313
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Kansas
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El Dorado, Kansas, Forenede Stater, 67042
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Newton, Kansas, Forenede Stater, 67114
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Kentucky
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Lexington, Kentucky, Forenede Stater, 40509
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Louisiana
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Covington, Louisiana, Forenede Stater, 70433
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Maryland
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Michigan
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Southfield, Michigan, Forenede Stater, 48075
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Missouri
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Kansas City, Missouri, Forenede Stater, 64111
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St Louis, Missouri, Forenede Stater, 63141
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89119
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South Carolina
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Anderson, South Carolina, Forenede Stater, 29621
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Tennessee
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Knoxville, Tennessee, Forenede Stater, 37909
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Texas
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Irving, Texas, Forenede Stater, 75061
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Washington
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Renton, Washington, Forenede Stater, 98057
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Athens, Grækenland, 10676
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Athens, Grækenland, 11526
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Athens, Grækenland, 15125
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Athens, Grækenland, 12131
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Heraklion, Grækenland, 71500
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Piraeus, Grækenland, 18454
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Thessaloniki, Grækenland, 57010
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Thessaloniki, Grækenland, 54636
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Thessaloniki, Grækenland, 57001
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Amagasaki-shi, Japan, 660-8550
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Chiba, Japan, 261-0004
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Chūōku, Japan, 1040031
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Minatoku, Japan, 105-0004
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Okayama, Japan, 701-1192
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Shinjuku-ku, Japan, 169-0072
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Zentsuji-shi, Japan, 765-0071
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Baotou, Kina, 014030
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Binzhou, Kina, 256606
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Cangzhou, Kina, 061002
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Changsha, Kina, 430033
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Chengdu, Kina, 610081
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Ganzhou, Kina, 341099
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Haikou, Kina, 570208
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Hangzhou, Kina, 310006
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Huangshi, Kina, 435000
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Huzhou, Kina, 313003
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Jinan, Kina, 250013
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Jinzhou, Kina, 121002
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Lanzhou, Kina, 730000
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Lianyungang, Kina, 222023
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Liaocheng, Kina, 252000
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Liuzhou, Kina, 545006
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Loudi, Kina, 417099
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Luoyang, Kina, 471003
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Luoyang, Kina, 471001
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Nanchang, Kina, 330006
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Nanjing, Kina, 211100
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Nanjing, Kina, 2100008
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Nanyang, Kina, 473000
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Ningbo, Kina, 315010
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Panjin, Kina, 124000
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Qingdao, Kina, 266035
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Sanmenxia, Kina, 472000
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Shanghai, Kina, 200040
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Suining Shi, Kina, 629000
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Tonghua, Kina, 134000
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Xi'an, Kina, 710077
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Xiangtan, Kina, 411100
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Xuancheng, Kina, 242000
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Yibin, Kina, 610500
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Yichang, Kina, 443003
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Yuncheng, Kina, 044099
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Zhengzhou, Kina, 450012
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Zhengzhou, Kina, 450002
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Zhenjiang, Kina, 212002
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Barcelona, Spanien, 08035
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Barcelona, Spanien, 08016
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Barcelona, Spanien, 08020
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Barcelona, Spanien, 08930
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Figueres, Spanien, 17600
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Seville, Spanien, 41003
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Seville, Spanien, 41950
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Brackenfell, Sydafrika, 7560
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Cape Town, Sydafrika, 7570
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Cape Town, Sydafrika, 7500
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Claremont, Sydafrika, 7708
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Durban, Sydafrika, 4093
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Johannesburg, Sydafrika, 1827
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KwaDukuza, Sydafrika, 4449
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Paarl, Sydafrika, 7646
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Pretoria, Sydafrika, 2
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eMkhomazi, Sydafrika, 4170
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Jongno-gu, Sydkorea, 110-746
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Seongnam-si, Sydkorea, 463-712
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Seoul, Sydkorea, 03080
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Seoul, Sydkorea, 5505
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Changhua, Taiwan, 500
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Kaohsiung City, Taiwan, 80756
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Kaohsiung City, Taiwan, 813
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New Taipei City, Taiwan, 220
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Taichung, Taiwan, 40705
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Taichung, Taiwan, 40201
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Taichung, Taiwan, 433004
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Tainan, Taiwan, 70403
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Tainan County, Taiwan, 71044
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Taipei, Taiwan, 10002
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Adana, Tyrkiet (Türkiye), 01060
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Ankara, Tyrkiet (Türkiye), 06530
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Ankara, Tyrkiet (Türkiye), 06560
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Bursa, Tyrkiet (Türkiye), 16310
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Izmir, Tyrkiet (Türkiye), 35340
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Kayseri, Tyrkiet (Türkiye), 38039
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Samsun, Tyrkiet (Türkiye), 55139
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Budapest, Ungarn, 1036
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Budapest, Ungarn, 1027
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Budapest, Ungarn, 1138
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Debrecen, Ungarn, 4032
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Dunaújváros, Ungarn, 2400
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Szeged, Ungarn, 6725
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Szolnok, Ungarn, 5000
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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:
- Diagnosed with Type 2 Diabetes Mellitus (T2DM) for at least 90 days prior to screening
- T2DM inadequately managed with lifestyle management alone or on stable treatment with other background glucose-lowering medication
- HbA1c value of ≥ 7% to ≤ 10.5% (53 to 91.3 mmol/mol)
- Body mass index (BMI) of ≥ 23 kg/m2 at screening
- Stable body weight (self-reported or documented) for 90 days prior to screening
Exclusion Criteria:
- Type 1 diabetes, secondary forms of diabetes (including congenital forms), or history of ketoacidosis or hyperosmolar coma
- Currently receiving or anticipated to receive, therapeutic intervention for diabetic retinopathy and/or macular edema
- Have had more than one episode of severe hypoglycemia within 180 days prior to screening or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms
- Clinically significant condition affecting the upper GI tract or chronic use of any medication that affects gastric motility or gastric emptying
- History of acute or chronic pancreatitis
- Severe congestive heart failure (New York Heart Association IV)
- History/family history of medullary thyroid cancer or multiple endocrine neoplasia type 2
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 |
|---|---|
|
Eksperimentel: Elecoglipron dose level 1 + dapagliflozin-matched placebo
Participants will receive elecoglipron at dose level 1 and dapagliflozin-matched placebo, administered orally once daily.
|
Elecoglipron is administered orally once daily.
A placebo matching dapagliflozin, administered orally once daily.
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|
Eksperimentel: Elecoglipron dose level 2 + dapagliflozin-matched placebo
Participants will receive elecoglipron at dose level 2 and dapagliflozin-matched placebo, administered orally once daily.
|
Elecoglipron is administered orally once daily.
A placebo matching dapagliflozin, administered orally once daily.
|
|
Eksperimentel: Elecoglipron (one of the studied dose levels) + dapagliflozin
Participants will receive elecoglipron at one of the study dose levels in combination with dapagliflozin, administered orally once daily.
|
Elecoglipron is administered orally once daily.
Dapagliflozin administered orally once daily.
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Placebo komparator: Elecoglipron-matched placebo + dapagliflozin-matched placebo
Participants will receive elecoglipron-matched placebo and dapagliflozin-matched placebo, administered orally once daily.
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A placebo matching dapagliflozin, administered orally once daily.
A placebo matching elecoglipron, administered orally once daily.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Change from baseline in Hemoglobin A1c (HbA1c)
Tidsramme: Baseline to Week 40
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Baseline to Week 40
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Achievement of HbA1c < 7% (53 mmol/mol)
Tidsramme: Week 40
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Week 40
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Achievement of HbA1c ≤ 6.5% (48 mmol/mol)
Tidsramme: Week 40
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Week 40
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Percent change in body weight
Tidsramme: Baseline to Week 40
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Baseline to Week 40
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Change from baseline in body weight
Tidsramme: Baseline to Week 40
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Baseline to Week 40
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Change from baseline in Systolic Blood Pressure (SBP)
Tidsramme: Baseline to Week 40
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Baseline to Week 40
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Time to initiation of rescue medication over 40 weeks
Tidsramme: Baseline to Week 40
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Baseline to Week 40
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Change from baseline in Diastolic Blood Pressure (DBP)
Tidsramme: Baseline to Week 40
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Baseline to Week 40
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Achievement of ≥5% weight loss from baseline
Tidsramme: Baseline to Week 40
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Baseline to Week 40
|
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 (Anslået)
6. juli 2026
Primær færdiggørelse (Anslået)
14. juli 2028
Studieafslutning (Anslået)
14. juli 2028
Datoer for studieregistrering
Først indsendt
18. juni 2026
Først indsendt, der opfyldte QC-kriterier
18. juni 2026
Først opslået (Faktiske)
23. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
23. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
18. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- D7261C00002
- 2025-523936-37-00 (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 .
Kliniske forsøg med Type 2 diabetes mellitus
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Instituto Nacional de Ciencias Medicas y Nutricion...Aktiv, ikke rekrutterende
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Endogenex, Inc.Ikke rekrutterer endnuDiabetes mellitus, type 2 | Diabetes | Type 2 diabetes | Type 2 diabetes mellitus (T2DM) | Type 2 Diabetes
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ENBIOSIS BIOTECHNOLOGIESAydin Adnan Menderes University; Izmir University of Economics; Buca Seyfi... og andre samarbejdspartnereRekrutteringType 2 diabetes | Diabetes mellitus type 2Tyrkiet (Türkiye)
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Endogenex, Inc.Ikke rekrutterer endnuDiabetes mellitus, type 2 | Diabetes | Type 2 diabetes mellitus | Type 2 diabetes | Type 2 diabetes
-
El Katib HospitalIkke rekrutterer endnuType 2 diabetes mellitus (T2DM)
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He Eye HospitalIkke rekrutterer endnu
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Diabetes Solutions InternationalDexCom, Inc.; Tidepool; MAVEN ProjectRekrutteringType 2 diabetes mellitus (T2DM)Forenede Stater
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Global Institute of Stem Cell Therapy and ResearchIkke rekrutterer endnu
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Daewoong Pharmaceutical Co. LTD.Ikke rekrutterer endnuT2DM (Type 2 Diabetes Mellitus)
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Zhongda HospitalRekrutteringType 2 diabetes mellitus (T2DM)Kina
Kliniske forsøg med Elecoglipron
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AstraZenecaParexelRekrutteringSunde deltagereForenede Stater