Once-daily ASC30 for adults who are overweight or obese with weight-related health issues

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 3, global, multicenter, randomized, double-blind, placebo-controlled trial. It compares three maintenance doses of ASC30 taken once daily against placebo over a long-term period to assess efficacy, safety, and tolerability in adults with obesity or overweight and weight-related comorbidities, not diabetes. Eligible participants are adults with BMI 30 or higher (or 27+ with a comorbidity) and a history of weight loss attempts. The trial is conducted at multiple sites, with ASC30 tablets or placebo as the intervention. Primary goals focus on sustained weight management and safety signals across diverse populations.

Why it matters

Who can join: the full rules

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.

Where it's running

• AURORA-1 Clinical Site
  Phoenix, Arizona, United States Recruiting
• AURORA-1 Clinical Site
  Melbourne, Florida, United States Recruiting
• AURORA-1 Clinical Site
  The Villages, Florida, United States Recruiting
• AURORA-1 Clinical Site
  Evansville, Indiana, United States Recruiting
• AURORA-1 Clinical Site
  Austin, Texas, United States Recruiting
• AURORA-1 Clinical Site
  San Antonio, Texas, United States Recruiting

+72 more sites. See ClinicalTrials.gov for the full list.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.