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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

RecruitingPhase 3Ages 18 Years - anyAllAscletis Pharma (China) Co., Limited
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Participant must be โ‰ฅ18 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 โ‰ฅ 30 kg/m2 or a BMI โ‰ฅ 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.
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What it tests

  • ASC30 tablets A1
  • Placebo
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Where

122 sites
AURORA-1 Clinical Site
Birmingham, United States
AURORA-1 Clinical Site
Huntsville, United States
AURORA-1 Clinical Site
Phoenix, United States
AURORA-1 Clinical Site
Tucson, United States
AURORA-1 Clinical Site
Little Rock, United States
AURORA-1 Clinical Site
Banning, United States
AURORA-1 Clinical Site
Chula Vista, United States
AURORA-1 Clinical Site
Covina, United States

โ€ฆand 114 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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