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.
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.
Hypertension
Dyslipidemia
Obstructive sleep apnea
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.
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 in body weight from baseline to Week 72
Change in waist circumference from baseline
Change in systolic blood pressure (SBP) from baseline
Percent change in fasting triglycerides from baseline
Change in body mass index (BMI) from baseline (kg/m²)
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