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RECRUITING Phase 3 ClinicalTrials.gov

A Study of Once-daily Oral ASC30 to Evaluate the Efficacy and Safety in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities

Sponsor: Ascletis Pharma (China) Co., Limited • ClinicalTrials.gov ID: NCT07743463

Registry updated: 2026-09-16
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Description

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.

Interventions

  • ASC30 tablets A1 (Drug)
    ASC30 tablets A1 administered orally once daily.
  • Placebo (Drug)
    Matching placebo tablets administered orally once daily.

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 ≥ 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). 3. Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight. Exclusion Criteria: 1. 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. 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 other glucagon-like peptide-1 Receptor Agonists (GLP-1 RA) analogs. 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.

Conditions

Obesity Overweight Chronic Weight Management

Locations

  • AURORA-1 Clinical Site — Birmingham, Alabama, United States
  • AURORA-1 Clinical Site — Huntsville, Alabama, United States
  • AURORA-1 Clinical Site — Phoenix, Arizona, United States
  • AURORA-1 Clinical Site — Tucson, Arizona, United States
  • AURORA-1 Clinical Site — Little Rock, Arkansas, United States
  • AURORA-1 Clinical Site — Banning, California, United States
  • AURORA-1 Clinical Site — Chula Vista, California, United States
  • AURORA-1 Clinical Site — Covina, California, United States
  • AURORA-1 Clinical Site — Gardena, California, United States
  • AURORA-1 Clinical Site — La Mesa, California, United States
  • AURORA-1 Clinical Site — Los Angeles, California, United States
  • AURORA-1 Clinical Site — Tarzana, California, United States
  • AURORA-1 Clinical Site — Tustin, California, United States
  • AURORA-1 Clinical Site — Washington D.C., District of Columbia, United States
  • AURORA-1 Clinical Site — Boca Raton, Florida, United States
  • AURORA-1 Clinical Site — Daytona Beach, Florida, United States
  • AURORA-1 Clinical Site — Jacksonville, Florida, United States
  • AURORA-1 Clinical Site — Leesburg, Florida, United States
  • AURORA-1 Clinical Site — Melbourne, Florida, United States
  • AURORA-1 Clinical Site — South Miami, Florida, United States
  • AURORA-1 Clinical Site — Tampa, Florida, United States
  • AURORA-1 Clinical Site — The Villages, Florida, United States
  • AURORA-1 Clinical Site — Winter Park, Florida, United States
  • AURORA-1 Clinical Site — Canton, Georgia, United States
  • AURORA-1 Clinical Site — Decatur, Georgia, United States
  • AURORA-1 Clinical Site — Union City, Georgia, United States
  • AURORA-1 Clinical Site — Boise, Idaho, United States
  • AURORA-1 Clinical Site — Schaumburg, Illinois, United States
  • AURORA-1 Clinical Site — Evansville, Indiana, United States
  • AURORA-1 Clinical Site — Indianapolis, Indiana, United States
  • AURORA-1 Clinical Site — Valparaiso, Indiana, United States
  • AURORA-1 Clinical Site — Kansas City, Kansas, United States
  • AURORA-1 Clinical Site — Baton Rouge, Louisiana, United States
  • AURORA-1 Clinical Site — Bowie, Maryland, United States
  • AURORA-1 Clinical Site — Rockville, Maryland, United States
  • AURORA-1 Clinical Site — Gulfport, Mississippi, United States
  • AURORA-1 Clinical Site — Jackson, Mississippi, United States
  • AURORA-1 Clinical Site — Olive Branch, Mississippi, United States
  • AURORA-1 Clinical Site — St Louis, Missouri, United States
  • AURORA-1 Clinical Site — Las Vegas, Nevada, United States
  • AURORA-1 Clinical Site — New Windsor, New York, United States
  • AURORA-1 Clinical Site — Charlotte, North Carolina, United States
  • AURORA-1 Clinical Site — Greenville, North Carolina, United States
  • AURORA-1 Clinical Site — Morehead City, North Carolina, United States
  • AURORA-1 Clinical Site — Raleigh, North Carolina, United States
  • AURORA-1 Clinical Site — Cincinnati, Ohio, United States
  • AURORA-1 Clinical Site — Cleveland, Ohio, United States
  • AURORA-1 Clinical Site — Columbus, Ohio, United States
  • AURORA-1 Clinical Site — Dayton, Ohio, United States
  • AURORA-1 Clinical Site — Eugene, Oregon, United States
  • AURORA-1 Clinical Site — Philadelphia, Pennsylvania, United States
  • AURORA-1 Clinical Site — Bluffton, South Carolina, United States
  • AURORA-1 Clinical Site — Clemson, South Carolina, United States
  • AURORA-1 Clinical Site — Columbia, South Carolina, United States
  • AURORA-1 Clinical Site — Gaffney, South Carolina, United States
  • AURORA-1 Clinical Site — Memphis, Tennessee, United States
  • AURORA-1 Clinical Site — Austin, Texas, United States
  • AURORA-1 Clinical Site — Brownsville, Texas, United States
  • AURORA-1 Clinical Site — DeSoto, Texas, United States
  • AURORA-1 Clinical Site — Frisco, Texas, United States
  • AURORA-1 Clinical Site — Mesquite, Texas, United States
  • AURORA-1 Clinical Site — San Antonio, Texas, United States
  • AURORA-1 Clinical Site — San Antonio, Texas, United States
  • AURORA-1 Clinical Site — Sugar Land, Texas, United States
  • AURORA-1 Clinical Site — Tomball, Texas, United States
  • AURORA-1 Clinical Site — Weslaco, Texas, United States
  • AURORA-1 Clinical Site — Wichita Falls, Texas, United States
  • AURORA-1 Clinical Site — Salt Lake City, Utah, United States
  • AURORA-1 Clinical Site — Hampton, Virginia, United States
  • AURORA-1 Clinical Site — Burlington, Canada
  • AURORA-1 Clinical Site — Pardubice, Czechia
  • AURORA-1 Clinical Site — Prague, Czechia
  • AURORA-1 Clinical Site — Prague, Czechia
  • AURORA-1 Clinical Site — Uherské Hradiště, Czechia
  • AURORA-1 Clinical Site — Berlin, Germany
  • AURORA-1 Clinical Site — Berlin, Germany
  • AURORA-1 Clinical Site — Essen, Germany
  • AURORA-1 Clinical Site — Hanover, Germany
  • AURORA-1 Clinical Site — Leipzig, Germany
  • AURORA-1 Clinical Site — Athens, Greece
  • AURORA-1 Clinical Site — Athens, Greece
  • AURORA-1 Clinical Site — Athens, Greece
  • AURORA-1 Clinical Site — Larissa, Greece
  • AURORA-1 Clinical Site — Marousi, Greece
  • AURORA-1 Clinical Site — Palaió Fáliro, Greece
  • AURORA-1 Clinical Site — Pylaia, Greece
  • AURORA-1 Clinical Site — Thessaloniki, Greece
  • AURORA-1 Clinical Site — Thessaloniki, Greece
  • AURORA-1 Clinical Site — Biała Podlaska, Poland
  • AURORA-1 Clinical Site — Bydgoszcz, Poland
  • AURORA-1 Clinical Site — Częstochowa, Poland
  • AURORA-1 Clinical Site — Gdansk, Poland
  • AURORA-1 Clinical Site — Gdynia, Poland
  • AURORA-1 Clinical Site — Gdynia, Poland
  • AURORA-1 Clinical Site — Katowice, Poland
  • AURORA-1 Clinical Site — Krakow, Poland
  • AURORA-1 Clinical Site — Krakow, Poland
  • AURORA-1 Clinical Site — Lodz, Poland
  • AURORA-1 Clinical Site — Lodz, Poland
  • AURORA-1 Clinical Site — Lublin, Poland
  • AURORA-1 Clinical Site — Lublin, Poland
  • AURORA-1 Clinical Site — Poznan, Poland
  • AURORA-1 Clinical Site — Poznan, Poland
  • AURORA-1 Clinical Site — Puławy, Poland
  • AURORA-1 Clinical Site — Siedlce, Poland
  • AURORA-1 Clinical Site — Staszów, Poland
  • AURORA-1 Clinical Site — Torun, Poland
  • AURORA-1 Clinical Site — Warsaw, Poland
  • AURORA-1 Clinical Site — Warsaw, Poland
  • AURORA-1 Clinical Site — Warsaw, Poland
  • AURORA-1 Clinical Site — Warsaw, Poland
  • AURORA-1 Clinical Site — Warsaw, Poland
  • AURORA-1 Clinical Site — Wroclaw, Poland
  • AURORA-1 Clinical Site — Wroclaw, Poland
  • AURORA-1 Clinical Site — Bellshill, United Kingdom
  • AURORA-1 Clinical Site — Cardiff, United Kingdom
  • AURORA-1 Clinical Site — Edgbaston, United Kingdom
  • AURORA-1 Clinical Site — London, United Kingdom
  • AURORA-1 Clinical Site — Manchester, United Kingdom
  • AURORA-1 Clinical Site — Manchester, United Kingdom
  • AURORA-1 Clinical Site — Stoke-on-Trent, United Kingdom
  • AURORA-1 Clinical Site — Warrington, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record