A Study of Once-daily Oral ASC30 to Evaluate the Efficacy and Safety in Adult Participants With Obesity or Overweight With Type 2 Diabetes (AURORA-2)
September 15, 2026 updated by: 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 Type 2 Diabetes Mellitus (AURORA-2)
Study ASC30-302 (AURORA-2) 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 and T2DM.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
1560
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Pardubice, Czechia, 530 02
- Not yet recruiting
- AURORA-2 Clinical Site
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Prague, Czechia, 120 00
- Not yet recruiting
- AURORA-2 Clinical Site
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Prague, Czechia, 150 00
- Not yet recruiting
- AURORA-2 Clinical Site
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Uherské Hradiště, Czechia, 686 01
- Not yet recruiting
- AURORA-2 Clinical Site
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Berlin, Germany, 10629
- Not yet recruiting
- AURORA-2 Clinical Site
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Berlin, Germany, 10787
- Not yet recruiting
- AURORA-2 Clinical Site
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Essen, Germany, 45355
- Not yet recruiting
- AURORA-2 Clinical Site
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Hanover, Germany, 30159
- Not yet recruiting
- AURORA-2 Clinical Site
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Athens, Greece, 106 76
- Not yet recruiting
- AURORA-2 Clinical Site
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Athens, Greece, 115 27
- Not yet recruiting
- AURORA-2 Clinical Site
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Athens, Greece, 115 28
- Not yet recruiting
- AURORA-2 Clinical Site
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Larissa, Greece, 411 10
- Not yet recruiting
- AURORA-2 Clinical Site
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Marousi, Greece, 151 23
- Not yet recruiting
- AURORA-2 Clinical Site
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Palaió Fáliro, Greece, 175 62
- Not yet recruiting
- AURORA-2 Clinical Site
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Pylaia, Greece, 570 01
- Not yet recruiting
- AURORA-2 Clinical Site
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Thessaloniki, Greece, 546 36
- Not yet recruiting
- AURORA-2 Clinical Site
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Thessaloniki, Greece, 546 42
- Not yet recruiting
- AURORA-2 Clinical Site
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Biała Podlaska, Poland, 21-500
- Not yet recruiting
- AURORA-2 Clinical Site
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Bydgoszcz, Poland, 85-092
- Not yet recruiting
- AURORA-2 Clinical Site
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Częstochowa, Poland, 42-202
- Not yet recruiting
- AURORA-2 Clinical Site
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Gdansk, Poland, 80-382
- Not yet recruiting
- AURORA-2 Clinical Site
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Gdynia, Poland, 81-384
- Not yet recruiting
- AURORA-2 Clinical Site
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Gdynia, Poland, 81-537
- Not yet recruiting
- AURORA-2 Clinical Site
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Katowice, Poland, 40-040
- Not yet recruiting
- AURORA-2 Clinical Site
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Krakow, Poland, 31-261
- Not yet recruiting
- AURORA-2 Clinical Site
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Krakow, Poland, 31-501
- Not yet recruiting
- AURORA-2 Clinical Site
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Lodz, Poland, 90-127
- Not yet recruiting
- AURORA-2 Clinical Site
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Lodz, Poland, 91-363
- Not yet recruiting
- AURORA-2 Clinical Site
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Lublin, Poland, 20-011
- Not yet recruiting
- AURORA-2 Clinical Site
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Lublin, Poland, 20-362
- Not yet recruiting
- AURORA-2 Clinical Site
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Poznan, Poland, 60-324
- Not yet recruiting
- AURORA-2 Clinical Site
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Poznan, Poland, 60-702
- Not yet recruiting
- AURORA-2 Clinical Site
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Puławy, Poland, 24-100
- Not yet recruiting
- AURORA-2 Clinical Site
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Siedlce, Poland, 08-110
- Not yet recruiting
- AURORA-2 Clinical Site
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Staszów, Poland, 28-200
- Not yet recruiting
- AURORA-2 Clinical Site
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Torun, Poland, 87-100
- Not yet recruiting
- AURORA-2 Clinical Site
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Warsaw, Poland, 00-215
- Not yet recruiting
- AURORA-2 Clinical Site
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Warsaw, Poland, 00-710
- Not yet recruiting
- AURORA-2 Clinical Site
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Warsaw, Poland, 01-696
- Not yet recruiting
- AURORA-2 Clinical Site
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Warsaw, Poland, 02-672
- Not yet recruiting
- AURORA-2 Clinical Site
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Warsaw, Poland, 03-291
- Not yet recruiting
- AURORA-2 Clinical Site
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Wroclaw, Poland, 50-381
- Not yet recruiting
- AURORA-2 Clinical Site
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Wroclaw, Poland, 53-673
- Not yet recruiting
- AURORA-2 Clinical Site
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Cardiff, United Kingdom, CF15 9SS
- Not yet recruiting
- AURORA-2 Clinical Site
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Edgbaston, United Kingdom, B16 8QQ
- Not yet recruiting
- AURORA-2 Clinical Site
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Glasgow, United Kingdom, ML43NJ
- Not yet recruiting
- AURORA-2 Clinical Site
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London, United Kingdom, E1 1AG
- Not yet recruiting
- AURORA-2 Clinical Site
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Manchester, United Kingdom, M11 1AA
- Not yet recruiting
- AURORA-2 Clinical Site
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Manchester, United Kingdom, M156SE
- Not yet recruiting
- AURORA-2 Clinical Site
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Stoke-on-Trent, United Kingdom, ST1 5SJ
- Not yet recruiting
- AURORA-2 Clinical Site
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Warrington, United Kingdom, WA1 3TZ
- Not yet recruiting
- AURORA-2 Clinical Site
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Alabama
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Birmingham, Alabama, United States, 35211-1320
- Not yet recruiting
- AURORA-2 Clinical Site
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Huntsville, Alabama, United States, 35802
- Not yet recruiting
- AURORA-2 Clinical Site
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Arizona
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Peoria, Arizona, United States, 85382
- Not yet recruiting
- AURORA-2 Clinical Site
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Phoenix, Arizona, United States, 85020
- Recruiting
- AURORA-2 Clinical Site
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Contact:
- Ascletis Recruiting
- Email: clinicaltrials@ascletis.com
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Tucson, Arizona, United States, 85741
- Not yet recruiting
- AURORA-2 Clinical Site
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Arkansas
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Little Rock, Arkansas, United States, 72204
- Not yet recruiting
- AURORA-2 Clinical Site
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California
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Banning, California, United States, 92220-3082
- Not yet recruiting
- AURORA-2 Clinical Site
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Chula Vista, California, United States, 91910
- Not yet recruiting
- AURORA-2 Clinical Site
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Covina, California, United States, 91723-1905
- Not yet recruiting
- AURORA-2 Clinical Site
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Gardena, California, United States, 90247-3583
- Not yet recruiting
- AURORA-2 Clinical Site
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La Mesa, California, United States, 91942
- Not yet recruiting
- AURORA-2 Clinical Site
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Los Angeles, California, United States, 91405
- Not yet recruiting
- AURORA-2 Clinical Site
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Sacramento, California, United States, 95821-2640
- Not yet recruiting
- AURORA-2 Clinical Site
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Tarzana, California, United States, 91356-3508
- Not yet recruiting
- AURORA-2 Clinical Site
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Tustin, California, United States, 92780-7074
- Not yet recruiting
- AURORA-2 Clinical Site
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District of Columbia
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Washington D.C., District of Columbia, United States, 20016
- Not yet recruiting
- AURORA-2 Clinical Site
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Florida
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Boca Raton, Florida, United States, 33434
- Not yet recruiting
- AURORA-2 Clinical Site
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Daytona Beach, Florida, United States, 32114
- Not yet recruiting
- AURORA-2 Clinical Site
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Jacksonville, Florida, United States, 32205-4785
- Not yet recruiting
- AURORA-2 Clinical Site
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Leesburg, Florida, United States, 34748-5077
- Not yet recruiting
- AURORA-2 Clinical Site
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Melbourne, Florida, United States, 32934-8172
- Recruiting
- AURORA-2 Clinical Site
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Contact:
- Ascletis Recruiting
- Email: clinicaltrials@ascletis.com
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South Miami, Florida, United States, 33143
- Not yet recruiting
- AURORA-2 Clinical Site
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Tampa, Florida, United States, 33613-1244
- Not yet recruiting
- AURORA-2 Clinical Site
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The Villages, Florida, United States, 32162
- Recruiting
- AURORA-2 Clinical Site
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Contact:
- Ascletis Recruiting
- Email: clinicaltrials@ascletis.com
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Winter Park, Florida, United States, 32789-4681
- Not yet recruiting
- AURORA-2 Clinical Site
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Georgia
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Canton, Georgia, United States, 30115
- Not yet recruiting
- AURORA-2 Clinical Site
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Decatur, Georgia, United States, 30030-3440
- Not yet recruiting
- AURORA-2 Clinical Site
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Union City, Georgia, United States, 30291-2085
- Not yet recruiting
- AURORA-2 Clinical Site
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Idaho
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Boise, Idaho, United States, 83704
- Not yet recruiting
- AURORA-2 Clinical Site
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Illinois
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Schaumburg, Illinois, United States, 60173
- Not yet recruiting
- AURORA-2 Clinical Site
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Indiana
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Evansville, Indiana, United States, 47714-7513
- Recruiting
- AURORA-2 Clinical Site
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Contact:
- Ascletis Recruiting
- Email: clinicaltrials@ascletis.com
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Indianapolis, Indiana, United States, 46254
- Not yet recruiting
- AURORA-2 Clinical Site
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Valparaiso, Indiana, United States, 46383
- Not yet recruiting
- AURORA-2 Clinical Site
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Kansas
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Kansas City, Kansas, United States, 66112
- Not yet recruiting
- AURORA-2 Clinical Site
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Louisiana
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Baton Rouge, Louisiana, United States, 70809-3416
- Not yet recruiting
- AURORA-2 Clinical Site
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Metairie, Louisiana, United States, 70006
- Not yet recruiting
- AURORA-2 Clinical Site
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Maryland
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Bowie, Maryland, United States, 20715
- Not yet recruiting
- AURORA-2 Clinical Site
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Rockville, Maryland, United States, 20854-2931
- Not yet recruiting
- AURORA-2 Clinical Site
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Michigan
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Southfield, Michigan, United States, 48076-5412
- Not yet recruiting
- AURORA-2 Clinical Site
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Minnesota
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Mankato, Minnesota, United States, 56001
- Not yet recruiting
- AURORA-2 Clinical Site
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Mississippi
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Gulfport, Mississippi, United States, 39503-2637
- Not yet recruiting
- AURORA-2 Clinical Site
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Jackson, Mississippi, United States, 39206
- Not yet recruiting
- AURORA-2 Clinical Site
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Olive Branch, Mississippi, United States, 38654-3514
- Not yet recruiting
- AURORA-2 Clinical Site
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Missouri
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Columbia, Missouri, United States, 65201
- Not yet recruiting
- AURORA-2 Clinical Site
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St Louis, Missouri, United States, 63141
- Not yet recruiting
- AURORA-2 Clinical Site
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Nevada
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Las Vegas, Nevada, United States, 89113
- Not yet recruiting
- AURORA-2 Clinical Site
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New Jersey
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Jersey City, New Jersey, United States, 07306-4004
- Not yet recruiting
- AURORA-2 Clinical Site
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New York
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East Northport, New York, United States, 11731
- Not yet recruiting
- AURORA-2 Clinical Site
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East Syracuse, New York, United States, 13057
- Not yet recruiting
- AURORA-2 Clinical Site
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New Windsor, New York, United States, 12553-7754
- Not yet recruiting
- AURORA-2 Clinical Site
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North Carolina
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Charlotte, North Carolina, United States, 28262
- Not yet recruiting
- AURORA-2 Clinical Site
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Durham, North Carolina, United States, 27701
- Not yet recruiting
- AURORA-2 Clinical Site
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Greenville, North Carolina, United States, 27834-5051
- Not yet recruiting
- AURORA-2 Clinical Site
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Morehead City, North Carolina, United States, 28557
- Not yet recruiting
- AURORA-2 Clinical Site
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Raleigh, North Carolina, United States, 27610
- Not yet recruiting
- AURORA-2 Clinical Site
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Ohio
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Cincinnati, Ohio, United States, 45246
- Not yet recruiting
- AURORA-2 Clinical Site
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Cleveland, Ohio, United States, 44122-4330
- Not yet recruiting
- AURORA-2 Clinical Site
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Columbus, Ohio, United States, 43212-3122
- Not yet recruiting
- AURORA-2 Clinical Site
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Dayton, Ohio, United States, 45414
- Not yet recruiting
- AURORA-2 Clinical Site
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73118-2872
- Not yet recruiting
- AURORA-2 Clinical Site
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Oregon
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Eugene, Oregon, United States, 97404-3233
- Not yet recruiting
- AURORA-2 Clinical Site
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
- Not yet recruiting
- AURORA-2 Clinical Site
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Pittsburgh, Pennsylvania, United States, 15243-1800
- Not yet recruiting
- AURORA-2 Clinical Site
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South Carolina
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Bluffton, South Carolina, United States, 29910
- Not yet recruiting
- AURORA-2 Clinical Site
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Clemson, South Carolina, United States, 29634
- Not yet recruiting
- AURORA-2 Clinical Site
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Columbia, South Carolina, United States, 29204
- Not yet recruiting
- AURORA-2 Clinical Site
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Gaffney, South Carolina, United States, 29340-4737
- Not yet recruiting
- AURORA-2 Clinical Site
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Tennessee
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Memphis, Tennessee, United States, 38119-4823
- Not yet recruiting
- AURORA-2 Clinical Site
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Texas
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Austin, Texas, United States, 78744-1645
- Recruiting
- AURORA-2 Clinical Site
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Contact:
- Ascletis Recruiting
- Email: clinicaltrials@ascletis.com
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Brownsville, Texas, United States, 78520
- Not yet recruiting
- AURORA-2 Clinical Site
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DeSoto, Texas, United States, 75115-2043
- Not yet recruiting
- AURORA-2 Clinical Site
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Frisco, Texas, United States, 75033-4133
- Not yet recruiting
- AURORA-2 Clinical Site
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Houston, Texas, United States, 77024
- Not yet recruiting
- AURORA-2 Clinical Site
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Mesquite, Texas, United States, 75149
- Not yet recruiting
- AURORA-2 Clinical Site
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San Antonio, Texas, United States, 78229-3272
- Recruiting
- AURORA-2 Clinical Site
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Contact:
- Ascletis Recruiting
- Email: clinicaltrials@ascletis.com
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San Antonio, Texas, United States, 78229-3539
- Not yet recruiting
- AURORA-2 Clinical Site
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Sugar Land, Texas, United States, 77478
- Not yet recruiting
- AURORA-2 Clinical Site
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Tomball, Texas, United States, 77375
- Not yet recruiting
- AURORA-2 Clinical Site
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Waxahachie, Texas, United States, 75165-1430
- Not yet recruiting
- AURORA-2 Clinical Site
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Weslaco, Texas, United States, 78596-7288
- Not yet recruiting
- AURORA-2 Clinical Site
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Wichita Falls, Texas, United States, 76301
- Not yet recruiting
- AURORA-2 Clinical Site
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Utah
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Salt Lake City, Utah, United States, 84124-3543
- Not yet recruiting
- AURORA-2 Clinical Site
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Virginia
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Hampton, Virginia, United States, 23666
- Not yet recruiting
- AURORA-2 Clinical Site
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Washington
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Seattle, Washington, United States, 98122
- Not yet recruiting
- AURORA-2 Clinical Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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 ≥ 27 kg/m2 at screening.
- Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.
- Have a diagnosis of T2D according to the WHO classification or other locally applicable standards, with HbA1c > 6.5% (48 mmol/mol) to ≤10.5% (91 mmol/mol) at screening.
Exclusion Criteria:
- Have Type 1 Diabetes Mellitus (T1DM), history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except T2DM.
- 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 glucagon-like peptide-1 Receptor Agonists (GLP-1 RA).
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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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Experimental: 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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Placebo Comparator: 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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Experimental: ASC30 Cohort 3
Participants will receive oral ASC30 tabletsA1.
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ASC30 tablets A1 administered orally once daily.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Percent change from baseline in body weight
Time Frame: Baseline to Week 72
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Baseline to Week 72
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Percent change from baseline in fasting non-HDL cholesterol
Time Frame: Baseline to Week 72
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Baseline to Week 72
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Change from baseline in HbA1c (%)
Time Frame: Baseline to Week 72
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Baseline to Week 72
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Change from baseline in fasting serum glucose (mg/dL)
Time Frame: Baseline to Week 72
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Baseline to Week 72
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Change from baseline in systolic blood pressure (SBP) (mmHg)
Time Frame: Baseline to Week 72
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Baseline to Week 72
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Percent change from baseline in fasting triglycerides
Time Frame: Baseline to Week 72
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Baseline to Week 72
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Change from baseline in BMI (kg/m²)
Time Frame: Baseline to Week 72
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Baseline to Week 72
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Change from baseline in fasting insulin (pmol/L)
Time Frame: Baseline to Week 72
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Baseline to Week 72
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Change from baseline in waist circumference (cm)
Time Frame: Baseline to Week 72
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Baseline to Week 72
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Change from baseline in diastolic blood pressure (DBP) (mmHg)
Time Frame: Baseline to Week 72
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Baseline to Week 72
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Percent change from baseline in fasting total cholesterol
Time Frame: Baseline to Week 72
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Baseline to Week 72
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 28, 2026
Primary Completion (Estimated)
July 1, 2028
Study Completion (Estimated)
July 1, 2028
Study Registration Dates
First Submitted
July 29, 2026
First Submitted That Met QC Criteria
July 29, 2026
First Posted (Actual)
August 3, 2026
Study Record Updates
Last Update Posted (Actual)
September 16, 2026
Last Update Submitted That Met QC Criteria
September 15, 2026
Last Verified
September 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ASC30-302
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.