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)
2026年9月15日 更新者：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.
研究概览
研究类型
介入性
注册 (估计的)
3003
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Burlington、加拿大、L7R 1E2
- 尚未招聘
- AURORA-1 Clinical Site
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Athens、希腊、106 76
- 尚未招聘
- AURORA-1 Clinical Site
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Athens、希腊、115 27
- 尚未招聘
- AURORA-1 Clinical Site
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Athens、希腊、115 28
- 尚未招聘
- AURORA-1 Clinical Site
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Larissa、希腊、411 10
- 尚未招聘
- AURORA-1 Clinical Site
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Marousi、希腊、151 23
- 尚未招聘
- AURORA-1 Clinical Site
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Palaió Fáliro、希腊、175 62
- 尚未招聘
- AURORA-1 Clinical Site
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Pylaia、希腊、570 01
- 尚未招聘
- AURORA-1 Clinical Site
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Thessaloniki、希腊、546 36
- 尚未招聘
- AURORA-1 Clinical Site
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Thessaloniki、希腊、546 42
- 尚未招聘
- AURORA-1 Clinical Site
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Berlin、德国、10629
- 尚未招聘
- AURORA-1 Clinical Site
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Berlin、德国、10787
- 尚未招聘
- AURORA-1 Clinical Site
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Essen、德国、45355
- 尚未招聘
- AURORA-1 Clinical Site
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Hanover、德国、30159
- 尚未招聘
- AURORA-1 Clinical Site
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Leipzig、德国、04107
- 尚未招聘
- AURORA-1 Clinical Site
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Pardubice、捷克语、530 02
- 尚未招聘
- AURORA-1 Clinical Site
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Prague、捷克语、120 00
- 尚未招聘
- AURORA-1 Clinical Site
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Prague、捷克语、150 00
- 尚未招聘
- AURORA-1 Clinical Site
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Uherské Hradiště、捷克语、686 01
- 尚未招聘
- AURORA-1 Clinical Site
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Biała Podlaska、波兰、21-500
- 尚未招聘
- AURORA-1 Clinical Site
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Bydgoszcz、波兰、85-092
- 尚未招聘
- AURORA-1 Clinical Site
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Częstochowa、波兰、42-202
- 尚未招聘
- AURORA-1 Clinical Site
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Gdansk、波兰、80-382
- 尚未招聘
- AURORA-1 Clinical Site
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Gdynia、波兰、81-384
- 尚未招聘
- AURORA-1 Clinical Site
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Gdynia、波兰、81-537
- 尚未招聘
- AURORA-1 Clinical Site
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Katowice、波兰、40-040
- 尚未招聘
- AURORA-1 Clinical Site
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Krakow、波兰、31-261
- 尚未招聘
- AURORA-1 Clinical Site
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Krakow、波兰、31-501
- 尚未招聘
- AURORA-1 Clinical Site
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Lodz、波兰、90-127
- 尚未招聘
- AURORA-1 Clinical Site
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Lodz、波兰、91-363
- 尚未招聘
- AURORA-1 Clinical Site
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Lublin、波兰、20-011
- 尚未招聘
- AURORA-1 Clinical Site
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Lublin、波兰、20-362
- 尚未招聘
- AURORA-1 Clinical Site
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Poznan、波兰、60-324
- 尚未招聘
- AURORA-1 Clinical Site
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Poznan、波兰、60-702
- 尚未招聘
- AURORA-1 Clinical Site
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Puławy、波兰、24-100
- 尚未招聘
- AURORA-1 Clinical Site
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Siedlce、波兰、08-110
- 尚未招聘
- AURORA-1 Clinical Site
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Staszów、波兰、28-200
- 尚未招聘
- AURORA-1 Clinical Site
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Torun、波兰、87-100
- 尚未招聘
- AURORA-1 Clinical Site
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Warsaw、波兰、00-215
- 尚未招聘
- AURORA-1 Clinical Site
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Warsaw、波兰、00-710
- 尚未招聘
- AURORA-1 Clinical Site
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Warsaw、波兰、01-696
- 尚未招聘
- AURORA-1 Clinical Site
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Warsaw、波兰、02-672
- 尚未招聘
- AURORA-1 Clinical Site
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Warsaw、波兰、03-291
- 尚未招聘
- AURORA-1 Clinical Site
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Wroclaw、波兰、50-381
- 尚未招聘
- AURORA-1 Clinical Site
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Wroclaw、波兰、53-673
- 尚未招聘
- AURORA-1 Clinical Site
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Alabama
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Birmingham、Alabama、美国、35211-1320
- 尚未招聘
- AURORA-1 Clinical Site
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Huntsville、Alabama、美国、35802
- 尚未招聘
- AURORA-1 Clinical Site
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Arizona
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Phoenix、Arizona、美国、85020
- 招聘中
- AURORA-1 Clinical Site
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接触：
- Ascletis Recruiting
- 邮箱：clinicaltrials@ascletis.com
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Tucson、Arizona、美国、85741
- 尚未招聘
- AURORA-1 Clinical Site
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Arkansas
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Little Rock、Arkansas、美国、72204
- 尚未招聘
- AURORA-1 Clinical Site
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California
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Banning、California、美国、92220-3082
- 尚未招聘
- AURORA-1 Clinical Site
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Chula Vista、California、美国、91910
- 尚未招聘
- AURORA-1 Clinical Site
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Covina、California、美国、91723-1905
- 尚未招聘
- AURORA-1 Clinical Site
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Gardena、California、美国、90247-3583
- 尚未招聘
- AURORA-1 Clinical Site
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La Mesa、California、美国、91942
- 尚未招聘
- AURORA-1 Clinical Site
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Los Angeles、California、美国、91405
- 尚未招聘
- AURORA-1 Clinical Site
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Tarzana、California、美国、91356-3508
- 尚未招聘
- AURORA-1 Clinical Site
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Tustin、California、美国、92780-7074
- 尚未招聘
- AURORA-1 Clinical Site
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District of Columbia
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Washington D.C.、District of Columbia、美国、20016
- 尚未招聘
- AURORA-1 Clinical Site
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Florida
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Boca Raton、Florida、美国、33434
- 尚未招聘
- AURORA-1 Clinical Site
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Daytona Beach、Florida、美国、32114
- 尚未招聘
- AURORA-1 Clinical Site
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Jacksonville、Florida、美国、32205-4785
- 尚未招聘
- AURORA-1 Clinical Site
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Leesburg、Florida、美国、34748-5077
- 尚未招聘
- AURORA-1 Clinical Site
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Melbourne、Florida、美国、32934-8172
- 招聘中
- AURORA-1 Clinical Site
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接触：
- Ascletis Recruiting
- 邮箱：clinicaltrials@ascletis.com
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South Miami、Florida、美国、33143
- 尚未招聘
- AURORA-1 Clinical Site
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Tampa、Florida、美国、33613-1244
- 尚未招聘
- AURORA-1 Clinical Site
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The Villages、Florida、美国、32162
- 招聘中
- AURORA-1 Clinical Site
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接触：
- Ascletis Recruiting
- 邮箱：clinicaltrials@ascletis.com
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Winter Park、Florida、美国、32789-4681
- 尚未招聘
- AURORA-1 Clinical Site
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Georgia
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Canton、Georgia、美国、30115
- 尚未招聘
- AURORA-1 Clinical Site
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Decatur、Georgia、美国、30030-3440
- 尚未招聘
- AURORA-1 Clinical Site
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Union City、Georgia、美国、30291-2085
- 尚未招聘
- AURORA-1 Clinical Site
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Idaho
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Boise、Idaho、美国、83704
- 尚未招聘
- AURORA-1 Clinical Site
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Illinois
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Schaumburg、Illinois、美国、60173
- 尚未招聘
- AURORA-1 Clinical Site
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Indiana
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Evansville、Indiana、美国、47714-7513
- 招聘中
- AURORA-1 Clinical Site
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接触：
- Ascletis Recruiting
- 邮箱：clinicaltrials@ascletis.com
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Indianapolis、Indiana、美国、46254
- 尚未招聘
- AURORA-1 Clinical Site
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Valparaiso、Indiana、美国、46383
- 尚未招聘
- AURORA-1 Clinical Site
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Kansas
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Kansas City、Kansas、美国、66112
- 尚未招聘
- AURORA-1 Clinical Site
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Louisiana
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Baton Rouge、Louisiana、美国、70809-3416
- 尚未招聘
- AURORA-1 Clinical Site
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Maryland
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Bowie、Maryland、美国、20715
- 尚未招聘
- AURORA-1 Clinical Site
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Rockville、Maryland、美国、20854-2931
- 尚未招聘
- AURORA-1 Clinical Site
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Mississippi
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Gulfport、Mississippi、美国、39503-2637
- 尚未招聘
- AURORA-1 Clinical Site
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Jackson、Mississippi、美国、39206
- 尚未招聘
- AURORA-1 Clinical Site
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Olive Branch、Mississippi、美国、38654-3514
- 尚未招聘
- AURORA-1 Clinical Site
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Missouri
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St Louis、Missouri、美国、63141
- 尚未招聘
- AURORA-1 Clinical Site
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Nevada
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Las Vegas、Nevada、美国、89113
- 尚未招聘
- AURORA-1 Clinical Site
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New York
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New Windsor、New York、美国、12553-7754
- 尚未招聘
- AURORA-1 Clinical Site
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North Carolina
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Charlotte、North Carolina、美国、28262
- 尚未招聘
- AURORA-1 Clinical Site
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Greenville、North Carolina、美国、27834-5051
- 尚未招聘
- AURORA-1 Clinical Site
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Morehead City、North Carolina、美国、28557
- 尚未招聘
- AURORA-1 Clinical Site
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Raleigh、North Carolina、美国、27610
- 尚未招聘
- AURORA-1 Clinical Site
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Ohio
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Cincinnati、Ohio、美国、45246
- 尚未招聘
- AURORA-1 Clinical Site
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Cleveland、Ohio、美国、44122-4330
- 尚未招聘
- AURORA-1 Clinical Site
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Columbus、Ohio、美国、43212-3122
- 尚未招聘
- AURORA-1 Clinical Site
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Dayton、Ohio、美国、45414
- 尚未招聘
- AURORA-1 Clinical Site
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Oregon
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Eugene、Oregon、美国、97404-3233
- 尚未招聘
- AURORA-1 Clinical Site
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19107
- 尚未招聘
- AURORA-1 Clinical Site
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South Carolina
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Bluffton、South Carolina、美国、29910
- 尚未招聘
- AURORA-1 Clinical Site
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Clemson、South Carolina、美国、29634
- 尚未招聘
- AURORA-1 Clinical Site
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Columbia、South Carolina、美国、29204
- 尚未招聘
- AURORA-1 Clinical Site
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Gaffney、South Carolina、美国、29340-4737
- 尚未招聘
- AURORA-1 Clinical Site
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Tennessee
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Memphis、Tennessee、美国、38119-4823
- 尚未招聘
- AURORA-1 Clinical Site
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Texas
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Austin、Texas、美国、78744-1645
- 招聘中
- AURORA-1 Clinical Site
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接触：
- Ascletis Recruiting
- 邮箱：clinicaltrials@ascletis.com
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Brownsville、Texas、美国、78520
- 尚未招聘
- AURORA-1 Clinical Site
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DeSoto、Texas、美国、75115-2043
- 尚未招聘
- AURORA-1 Clinical Site
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Frisco、Texas、美国、75033-4133
- 尚未招聘
- AURORA-1 Clinical Site
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Mesquite、Texas、美国、75149
- 尚未招聘
- AURORA-1 Clinical Site
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San Antonio、Texas、美国、78229-3272
- 招聘中
- AURORA-1 Clinical Site
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接触：
- Ascletis Recruiting
- 邮箱：clinicaltrials@ascletis.com
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San Antonio、Texas、美国、78229-3539
- 尚未招聘
- AURORA-1 Clinical Site
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Sugar Land、Texas、美国、77478
- 尚未招聘
- AURORA-1 Clinical Site
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Tomball、Texas、美国、77375
- 尚未招聘
- AURORA-1 Clinical Site
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Weslaco、Texas、美国、78596-7288
- 尚未招聘
- AURORA-1 Clinical Site
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Wichita Falls、Texas、美国、76301
- 尚未招聘
- AURORA-1 Clinical Site
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Utah
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Salt Lake City、Utah、美国、84124-3543
- 尚未招聘
- AURORA-1 Clinical Site
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Virginia
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Hampton、Virginia、美国、23666
- 尚未招聘
- AURORA-1 Clinical Site
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Bellshill、英国、ML4 3NJ
- 尚未招聘
- AURORA-1 Clinical Site
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Cardiff、英国、CF15 9SS
- 尚未招聘
- AURORA-1 Clinical Site
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Edgbaston、英国、B16 8QQ
- 尚未招聘
- AURORA-1 Clinical Site
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London、英国、E1 1AG
- 尚未招聘
- AURORA-1 Clinical Site
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Manchester、英国、M11 1AA
- 尚未招聘
- AURORA-1 Clinical Site
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Manchester、英国、M156SE
- 尚未招聘
- AURORA-1 Clinical Site
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Stoke-on-Trent、英国、ST1 5SJ
- 尚未招聘
- AURORA-1 Clinical Site
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Warrington、英国、WA1 3TZ
- 尚未招聘
- AURORA-1 Clinical Site
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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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实验性的：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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实验性的：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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安慰剂比较：Placebo Cohort 4
Participants will receive matching placebo tablets orally once daily.
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Matching placebo tablets administered orally once daily.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Percent change in body weight from baseline to Week 72
大体时间：Baseline to Week 72
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Baseline to Week 72
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次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Change in waist circumference from baseline
大体时间：Baseline to Week 72
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Baseline to Week 72
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Change in systolic blood pressure (SBP) from baseline
大体时间：Baseline to Week 72
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Baseline to Week 72
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Percent change in fasting triglycerides from baseline
大体时间：Baseline to Week 72
|
Baseline to Week 72
|
|
Change in body mass index (BMI) from baseline (kg/m²)
大体时间：Baseline to Week 72
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Baseline to Week 72
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Change in HbA1c from baseline (%)
大体时间：Baseline to Week 72
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Baseline to Week 72
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Percent change from baseline in fasting non-HDL cholesterol
大体时间：Baseline to Week 72
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Baseline to Week 72
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Change in fasting glucose from baseline (mg/dL)
大体时间：Baseline to Week 72
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Baseline to Week 72
|
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Change in fasting insulin from baseline (pmol/L)
大体时间：Baseline to Week 72
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Baseline to Week 72
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Change in diastolic blood pressure (DBP) from baseline
大体时间：Baseline to Week 72
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Baseline to Week 72
|
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Percent change in fasting total cholesterol from baseline
大体时间：Baseline to Week 72
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Baseline to Week 72
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年8月31日
初级完成 (估计的)
2028年7月1日
研究完成 (估计的)
2028年7月1日
研究注册日期
首次提交
2026年7月29日
首先提交符合 QC 标准的
2026年7月29日
首次发布 (实际的)
2026年8月3日
研究记录更新
最后更新发布 (实际的)
2026年9月16日
上次提交的符合 QC 标准的更新
2026年9月15日
最后验证
2026年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.