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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 Weight-Related Comorbidities

NCT07743463

RecruitingPhase 3

Sponsor: Ascletis Pharma (China) Co., Limited

Conditions: Obesity, Overweight, Chronic Weight Management

Interventions: ASC30 tablets A1, Placebo

Countries: United States, Canada, Czechia, Germany, Greece, Poland, United Kingdom

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (120)

Birmingham, Alabama, United States
Huntsville, Alabama, United States
Phoenix, Arizona, United States
Tempe, Arizona, United States
Tucson, Arizona, United States
Little Rock, Arkansas, United States
Banning, California, United States
Chula Vista, California, United States
Covina, California, United States
Gardena, California, United States
Tarzana, California, United States
Tustin, California, United States
Washington D.C., District of Columbia, United States
Boca Raton, Florida, United States
Daytona Beach, Florida, United States
Jacksonville, Florida, United States
Leesburg, Florida, United States
Melbourne, Florida, United States
South Miami, Florida, United States
Tampa, Florida, United States
The Villages, Florida, United States
Winter Park, Florida, United States
Canton, Georgia, United States
Decatur, Georgia, United States
Union City, Georgia, United States
Boise, Idaho, United States
Schaumburg, Illinois, United States
Evansville, Indiana, United States
Indianapolis, Indiana, United States
Valparaiso, Indiana, United States
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