A Study of Once-daily Oral ASC30 to Evaluate the Efficacy and Safety in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities
Recruiting · NCT07743463 · Interventional (participants receive a specific treatment) · Lead sponsor: Ascletis Pharma (China) Co., Limited
View the official record on ClinicalTrials.gov →Interventions studied
ASC30 tablets A1Placebo
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
60 locations listed across 25 US states.
- 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 - Tempe, 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 - 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 - Bowie, Maryland, United States
- AURORA-1 Clinical Site - Rockville, Maryland, 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 - Pittsburgh, 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 - 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 - Houston, Texas, United States
- AURORA-1 Clinical Site - Mesquite, Texas, United States
- AURORA-1 Clinical Site - San Antonio, Texas, United States
Showing 60 of 120 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →