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A Study of Once-daily Oral ASC30 to Evaluate the Efficacy and Safety in Adult Participants With Obesity or Overweight With Type 2 Diabetes

NCT07743450 · Ascletis Pharma Inc
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Official title
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)
About this study
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.
Eligibility criteria
Inclusion Criteria: 1. 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. 2. Have a BMI ≥ 27 kg/m2 at screening. 3. Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight. 4. 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: 1. Have Type 1 Diabetes Mellitus (T1DM), history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except T2DM. 2. Have a self-reported change in body weight \>5 kg (11 pounds) within 3 months prior to screening. 3. Have an estimated glomerular filtration rate (eGFR) \< 15 mL/min/1.73 m2, as determined by the laboratory at screening. 4. Have a history of acute or chronic pancreatitis any time prior to screening. 5. Have known allergies or intolerance to glucagon-like peptide-1 Receptor Agonists (GLP-1 RA). 6. Participants with a personal or family (first-degree relative) history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia (MEN) syndrome type 2. 7. 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 design
Enrollment target: 1560 participants
Allocation: randomized
Masking: triple
Age groups: adult, older_adult
Timeline
Starts: 2026-08-28
Estimated completion: 2028-07
Last updated: 2026-09-16
Interventions
Drug: ASC30 tablets A1Drug: Placebo
Primary outcomes
  • Percent change from baseline in body weight (Baseline to Week 72)
Sponsor
Ascletis Pharma (China) Co., Limited · industry
All locations (135)
AURORA-2 Clinical SiteNot Yet Recruiting
Birmingham, Alabama, United States
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Huntsville, Alabama, United States
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Peoria, Arizona, United States
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Little Rock, Arkansas, United States
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Banning, California, United States
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Chula Vista, California, United States
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Covina, California, United States
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Gardena, California, United States
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La Mesa, California, United States
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Los Angeles, California, United States
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Sacramento, California, United States
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Tarzana, California, United States
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Tustin, California, United States
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Washington D.C., District of Columbia, United States
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Boca Raton, Florida, United States
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Daytona Beach, Florida, United States
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Jacksonville, Florida, United States
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Leesburg, Florida, United States
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Melbourne, Florida, United States
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South Miami, Florida, United States
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Tampa, Florida, United States
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The Villages, Florida, United States
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Winter Park, Florida, United States
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Canton, Georgia, United States
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Decatur, Georgia, United States
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Union City, Georgia, United States
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Boise, Idaho, United States
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Schaumburg, Illinois, United States
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Evansville, Indiana, United States
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Indianapolis, Indiana, United States
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Valparaiso, Indiana, United States
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Kansas City, Kansas, United States
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Baton Rouge, Louisiana, United States
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Metairie, Louisiana, United States
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Bowie, Maryland, United States
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Rockville, Maryland, United States
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Southfield, Michigan, United States
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Mankato, Minnesota, United States
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Gulfport, Mississippi, United States
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Jackson, Mississippi, United States
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Olive Branch, Mississippi, United States
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Columbia, Missouri, United States
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St Louis, Missouri, United States
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Las Vegas, Nevada, United States
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Jersey City, New Jersey, United States
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East Northport, New York, United States
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East Syracuse, New York, United States
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New Windsor, New York, United States
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Charlotte, North Carolina, United States
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Durham, North Carolina, United States
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Greenville, North Carolina, United States
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Morehead City, North Carolina, United States
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Raleigh, North Carolina, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Dayton, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Eugene, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Bluffton, South Carolina, United States
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Clemson, South Carolina, United States
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Columbia, South Carolina, United States
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Gaffney, South Carolina, United States
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Memphis, Tennessee, United States
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Austin, Texas, United States
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Brownsville, Texas, United States
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DeSoto, Texas, United States
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Frisco, Texas, United States
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Houston, Texas, United States
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Mesquite, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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Sugar Land, Texas, United States
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Tomball, Texas, United States
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Waxahachie, Texas, United States
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Weslaco, Texas, United States
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Wichita Falls, Texas, United States
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Salt Lake City, Utah, United States
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Hampton, Virginia, United States
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Seattle, Washington, United States
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Pardubice, Czechia
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Prague, Czechia
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Prague, Czechia
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Uherské Hradiště, Czechia
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Berlin, Germany
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Berlin, Germany
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Essen, Germany
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Hanover, Germany
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Athens, Greece
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Athens, Greece
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Athens, Greece
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Larissa, Greece
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Marousi, Greece
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Palaió Fáliro, Greece
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Pylaia, Greece
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Thessaloniki, Greece
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Thessaloniki, Greece
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Biała Podlaska, Poland
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Bydgoszcz, Poland
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Częstochowa, Poland
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Gdansk, Poland
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Gdynia, Poland
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Gdynia, Poland
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Katowice, Poland
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Krakow, Poland
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Krakow, Poland
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Lodz, Poland
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Lodz, Poland
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Lublin, Poland
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Lublin, Poland
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Poznan, Poland
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Poznan, Poland
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Puławy, Poland
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Siedlce, Poland
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Staszów, Poland
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Torun, Poland
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Warsaw, Poland
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Warsaw, Poland
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Warsaw, Poland
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Warsaw, Poland
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Warsaw, Poland
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Wroclaw, Poland
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Wroclaw, Poland
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Cardiff, United Kingdom
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Edgbaston, United Kingdom
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Glasgow, United Kingdom
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London, United Kingdom
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Manchester, United Kingdom
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Manchester, United Kingdom
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Stoke-on-Trent, United Kingdom
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Warrington, United Kingdom
A Study of Once-daily Oral ASC30 to Evaluate the Efficacy and Safety in Adult Participants With Obesity or Overweight With Type 2 Diabetes · TrialPath