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.
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.
Have a BMI ≥ 27 kg/m2 at screening.
Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.
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.
Have Type 1 Diabetes Mellitus (T1DM), history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except T2DM.
Have a self-reported change in body weight >5 kg (11 pounds) within 3 months prior to screening.
Have an estimated glomerular filtration rate (eGFR) < 15 mL/min/1.73 m2, as determined by the laboratory at screening.
Have a history of acute or chronic pancreatitis any time prior to screening.
Parallel
ASC30 tablets A1
DrugASC30 tablets A1 administered orally once daily.
Placebo
DrugMatching placebo tablets administered orally once daily.
Percent change from baseline in body weight
Change from baseline in HbA1c (%)
Change from baseline in fasting serum glucose (mg/dL)
Change from baseline in systolic blood pressure (SBP) (mmHg)
Percent change from baseline in fasting non-HDL cholesterol
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