A Study of Once-daily Oral ASC30 to Evaluate the Efficacy and Safety in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities (AURORA-1)
15. september 2026 opdateret af: Ascletis Pharma (China) Co., Limited
A Phase III, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Once-Daily Oral ASC30 in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities (AURORA-1)
Study ASC30-301 (AURORA-1) is a Phase III, global, multicenter, randomized, double-blind, placebo-controlled study to investigate the long-term efficacy, safety, and tolerability of three maintenance doses of once-daily oral ASC30 compared with placebo in participants with obesity or overweight without T2DM.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
3003
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Burlington, Canada, L7R 1E2
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Bellshill, Det Forenede Kongerige, ML4 3NJ
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Cardiff, Det Forenede Kongerige, CF15 9SS
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Edgbaston, Det Forenede Kongerige, B16 8QQ
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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London, Det Forenede Kongerige, E1 1AG
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Manchester, Det Forenede Kongerige, M11 1AA
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Manchester, Det Forenede Kongerige, M156SE
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Stoke-on-Trent, Det Forenede Kongerige, ST1 5SJ
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Warrington, Det Forenede Kongerige, WA1 3TZ
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Alabama
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Birmingham, Alabama, Forenede Stater, 35211-1320
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Huntsville, Alabama, Forenede Stater, 35802
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Arizona
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Phoenix, Arizona, Forenede Stater, 85020
- Rekruttering
- AURORA-1 Clinical Site
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Kontakt:
- Ascletis Recruiting
- E-mail: clinicaltrials@ascletis.com
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Tucson, Arizona, Forenede Stater, 85741
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Arkansas
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Little Rock, Arkansas, Forenede Stater, 72204
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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California
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Banning, California, Forenede Stater, 92220-3082
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Chula Vista, California, Forenede Stater, 91910
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Covina, California, Forenede Stater, 91723-1905
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Gardena, California, Forenede Stater, 90247-3583
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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La Mesa, California, Forenede Stater, 91942
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Los Angeles, California, Forenede Stater, 91405
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Tarzana, California, Forenede Stater, 91356-3508
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Tustin, California, Forenede Stater, 92780-7074
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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District of Columbia
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Washington D.C., District of Columbia, Forenede Stater, 20016
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Florida
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Boca Raton, Florida, Forenede Stater, 33434
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Daytona Beach, Florida, Forenede Stater, 32114
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Jacksonville, Florida, Forenede Stater, 32205-4785
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Leesburg, Florida, Forenede Stater, 34748-5077
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Melbourne, Florida, Forenede Stater, 32934-8172
- Rekruttering
- AURORA-1 Clinical Site
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Kontakt:
- Ascletis Recruiting
- E-mail: clinicaltrials@ascletis.com
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South Miami, Florida, Forenede Stater, 33143
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Tampa, Florida, Forenede Stater, 33613-1244
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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The Villages, Florida, Forenede Stater, 32162
- Rekruttering
- AURORA-1 Clinical Site
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Kontakt:
- Ascletis Recruiting
- E-mail: clinicaltrials@ascletis.com
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Winter Park, Florida, Forenede Stater, 32789-4681
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Georgia
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Canton, Georgia, Forenede Stater, 30115
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Decatur, Georgia, Forenede Stater, 30030-3440
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Union City, Georgia, Forenede Stater, 30291-2085
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Idaho
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Boise, Idaho, Forenede Stater, 83704
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Illinois
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Schaumburg, Illinois, Forenede Stater, 60173
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Indiana
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Evansville, Indiana, Forenede Stater, 47714-7513
- Rekruttering
- AURORA-1 Clinical Site
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Kontakt:
- Ascletis Recruiting
- E-mail: clinicaltrials@ascletis.com
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Indianapolis, Indiana, Forenede Stater, 46254
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Valparaiso, Indiana, Forenede Stater, 46383
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Kansas
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Kansas City, Kansas, Forenede Stater, 66112
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Louisiana
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Baton Rouge, Louisiana, Forenede Stater, 70809-3416
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Maryland
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Bowie, Maryland, Forenede Stater, 20715
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Rockville, Maryland, Forenede Stater, 20854-2931
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Mississippi
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Gulfport, Mississippi, Forenede Stater, 39503-2637
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Jackson, Mississippi, Forenede Stater, 39206
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Olive Branch, Mississippi, Forenede Stater, 38654-3514
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Missouri
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St Louis, Missouri, Forenede Stater, 63141
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89113
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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New York
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New Windsor, New York, Forenede Stater, 12553-7754
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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North Carolina
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Charlotte, North Carolina, Forenede Stater, 28262
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Greenville, North Carolina, Forenede Stater, 27834-5051
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Morehead City, North Carolina, Forenede Stater, 28557
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Raleigh, North Carolina, Forenede Stater, 27610
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Ohio
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Cincinnati, Ohio, Forenede Stater, 45246
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Cleveland, Ohio, Forenede Stater, 44122-4330
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Columbus, Ohio, Forenede Stater, 43212-3122
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Dayton, Ohio, Forenede Stater, 45414
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Oregon
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Eugene, Oregon, Forenede Stater, 97404-3233
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19107
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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South Carolina
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Bluffton, South Carolina, Forenede Stater, 29910
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Clemson, South Carolina, Forenede Stater, 29634
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Columbia, South Carolina, Forenede Stater, 29204
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Gaffney, South Carolina, Forenede Stater, 29340-4737
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Tennessee
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Memphis, Tennessee, Forenede Stater, 38119-4823
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Texas
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Austin, Texas, Forenede Stater, 78744-1645
- Rekruttering
- AURORA-1 Clinical Site
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Kontakt:
- Ascletis Recruiting
- E-mail: clinicaltrials@ascletis.com
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Brownsville, Texas, Forenede Stater, 78520
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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DeSoto, Texas, Forenede Stater, 75115-2043
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Frisco, Texas, Forenede Stater, 75033-4133
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Mesquite, Texas, Forenede Stater, 75149
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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San Antonio, Texas, Forenede Stater, 78229-3272
- Rekruttering
- AURORA-1 Clinical Site
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Kontakt:
- Ascletis Recruiting
- E-mail: clinicaltrials@ascletis.com
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San Antonio, Texas, Forenede Stater, 78229-3539
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Sugar Land, Texas, Forenede Stater, 77478
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Tomball, Texas, Forenede Stater, 77375
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Weslaco, Texas, Forenede Stater, 78596-7288
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Wichita Falls, Texas, Forenede Stater, 76301
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Utah
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Salt Lake City, Utah, Forenede Stater, 84124-3543
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Virginia
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Hampton, Virginia, Forenede Stater, 23666
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Athens, Grækenland, 106 76
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Athens, Grækenland, 115 27
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Athens, Grækenland, 115 28
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Larissa, Grækenland, 411 10
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Marousi, Grækenland, 151 23
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Palaió Fáliro, Grækenland, 175 62
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Pylaia, Grækenland, 570 01
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Thessaloniki, Grækenland, 546 36
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Thessaloniki, Grækenland, 546 42
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Biała Podlaska, Polen, 21-500
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Bydgoszcz, Polen, 85-092
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Częstochowa, Polen, 42-202
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Gdansk, Polen, 80-382
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Gdynia, Polen, 81-384
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Gdynia, Polen, 81-537
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Katowice, Polen, 40-040
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Krakow, Polen, 31-261
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Krakow, Polen, 31-501
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Lodz, Polen, 90-127
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Lodz, Polen, 91-363
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Lublin, Polen, 20-011
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Lublin, Polen, 20-362
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Poznan, Polen, 60-324
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Poznan, Polen, 60-702
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Puławy, Polen, 24-100
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Siedlce, Polen, 08-110
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Staszów, Polen, 28-200
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Torun, Polen, 87-100
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Warsaw, Polen, 00-215
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Warsaw, Polen, 00-710
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Warsaw, Polen, 01-696
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Warsaw, Polen, 02-672
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Warsaw, Polen, 03-291
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Wroclaw, Polen, 50-381
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Wroclaw, Polen, 53-673
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Pardubice, Tjekkiet, 530 02
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Prague, Tjekkiet, 120 00
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Prague, Tjekkiet, 150 00
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Uherské Hradiště, Tjekkiet, 686 01
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Berlin, Tyskland, 10629
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Berlin, Tyskland, 10787
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Essen, Tyskland, 45355
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Hanover, Tyskland, 30159
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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Leipzig, Tyskland, 04107
- Ikke rekrutterer endnu
- AURORA-1 Clinical Site
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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:
- Participant must be ≥18 years of age inclusive, or the legal age of consent in the jurisdiction in which the study is taking place at screening.
Have a BMI ≥ 30 kg/m2 or a BMI ≥ 27 kg/m2 and presence of at least 1 of the following weight-related comorbidities (treated or untreated) at screening:
- Hypertension
- Dyslipidemia
- Obstructive sleep apnea
- Cardiovascular disease (for example, ischemic cardiovascular disease, New York Heart Association Functional Class I-III heart failure).
- Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.
Exclusion Criteria:
- Have any prior diagnosis of diabetes mellitus (T1DM or T2DM), or any other types of diabetes, history of ketoacidosis, or hyperosmolar state/coma. Participants with a history of gestational diabetes are eligible to participate in this trial.
- Have a self-reported change in body weight >5 kg (11 pounds) within 3 months prior to screening.
- Have an estimated glomerular filtration rate (eGFR) < 15 mL/min/1.73 m2, as determined by the laboratory at screening.
- Have a history of acute or chronic pancreatitis any time prior to screening.
- Have known allergies or intolerance to other glucagon-like peptide-1 Receptor Agonists (GLP-1 RA) analogs.
- Participants with a personal or family (first-degree relative) history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia (MEN) syndrome type 2.
- Are currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study at the investigator's discretion.
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: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: ASC30 Cohort 1
Participants will receive oral ASC30 tablets A1.
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ASC30 tablets A1 administered orally once daily.
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Eksperimentel: ASC30 Cohort 2
Participants will receive oral ASC30 tablets A1.
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ASC30 tablets A1 administered orally once daily.
|
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Eksperimentel: ASC30 Cohort 3
Participants will receive oral ASC30 tablets A1.
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ASC30 tablets A1 administered orally once daily.
|
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Placebo komparator: Placebo Cohort 4
Participants will receive matching placebo tablets orally once daily.
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Matching placebo tablets administered orally once daily.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Percent change in body weight from baseline to Week 72
Tidsramme: Baseline to Week 72
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Baseline to Week 72
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Change in waist circumference from baseline
Tidsramme: Baseline to Week 72
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Baseline to Week 72
|
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Change in systolic blood pressure (SBP) from baseline
Tidsramme: Baseline to Week 72
|
Baseline to Week 72
|
|
Percent change in fasting triglycerides from baseline
Tidsramme: Baseline to Week 72
|
Baseline to Week 72
|
|
Change in body mass index (BMI) from baseline (kg/m²)
Tidsramme: Baseline to Week 72
|
Baseline to Week 72
|
|
Change in HbA1c from baseline (%)
Tidsramme: Baseline to Week 72
|
Baseline to Week 72
|
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Percent change from baseline in fasting non-HDL cholesterol
Tidsramme: Baseline to Week 72
|
Baseline to Week 72
|
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Change in fasting glucose from baseline (mg/dL)
Tidsramme: Baseline to Week 72
|
Baseline to Week 72
|
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Change in fasting insulin from baseline (pmol/L)
Tidsramme: Baseline to Week 72
|
Baseline to Week 72
|
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Change in diastolic blood pressure (DBP) from baseline
Tidsramme: Baseline to Week 72
|
Baseline to Week 72
|
|
Percent change in fasting total cholesterol from baseline
Tidsramme: Baseline to Week 72
|
Baseline to Week 72
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
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)
31. august 2026
Primær færdiggørelse (Anslået)
1. juli 2028
Studieafslutning (Anslået)
1. juli 2028
Datoer for studieregistrering
Først indsendt
29. juli 2026
Først indsendt, der opfyldte QC-kriterier
29. juli 2026
Først opslået (Faktiske)
3. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
16. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
15. september 2026
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ASC30-301
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 .