Once-daily ASC30 to See if it helps adults with obesity or overweight and Type 2 diabetes

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 evaluating long-term efficacy, safety, and tolerability of three maintenance doses of ASC30 given once daily in adults with obesity or overweight and Type 2 diabetes. Participants are randomly assigned to ASC30 or placebo and followed to assess weight change and metabolic outcomes while monitoring adverse events. The study aims to determine whether ASC30 provides meaningful weight management benefits in addition to standard diabetes care. Enrollment targets adults aged 18 and older with BMI ≥27 kg/m2 and HbA1c between 6.5% and 10.5%.

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 ≥ 27 kg/m2 at screening.
3. Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.
4. Have a diagnosis of T2D according to the WHO classification or other locally applicable standards, with HbA1c \> 6.5% (48 mmol/mol) to ≤10.5% (91 mmol/mol) at screening.

Exclusion Criteria:

1. Have Type 1 Diabetes Mellitus (T1DM), history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except T2DM.
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 glucagon-like peptide-1 Receptor Agonists (GLP-1 RA).
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-2 Clinical Site
  Phoenix, Arizona, United States Recruiting
• AURORA-2 Clinical Site
  Melbourne, Florida, United States Recruiting
• AURORA-2 Clinical Site
  The Villages, Florida, United States Recruiting
• AURORA-2 Clinical Site
  Evansville, Indiana, United States Recruiting
• AURORA-2 Clinical Site
  Austin, Texas, United States Recruiting
• AURORA-2 Clinical Site
  San Antonio, Texas, United States Recruiting

+85 more sites. See ClinicalTrials.gov for the full list.

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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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.