RecruitingObesityOverweightChronic Weight Management

A Study of Once-daily Oral ASC30 to Evaluate the Efficacy and Safety in Adult Participants With Obesity or Overweight With Type 2 Diabetes

Eligible age

18+ yrs

Accepts

All genders

Locations

31 states

Healthy volunteers

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About this study

Study ASC30-302 (AURORA-2) 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 and T2DM.

Sponsor: Ascletis Pharma (China) Co., Limited

You may qualify if…

✓ 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.

You may not qualify if…

✕ 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.