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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
3,003
ASC30 tablets A1 administered orally once daily.
Matching placebo tablets administered orally once daily.
AURORA-1 Clinical Site
Birmingham, Alabama, United States
NOT_YET_RECRUITINGAURORA-1 Clinical Site
Huntsville, Alabama, United States
NOT_YET_RECRUITINGAURORA-1 Clinical Site
Phoenix, Arizona, United States
RECRUITINGAURORA-1 Clinical Site
Tucson, Arizona, United States
Percent change in body weight from baseline to Week 72
Time frame: Baseline to Week 72
Change in waist circumference from baseline
Time frame: Baseline to Week 72
Change in systolic blood pressure (SBP) from baseline
Time frame: Baseline to Week 72
Percent change in fasting triglycerides from baseline
Time frame: Baseline to Week 72
Change in body mass index (BMI) from baseline (kg/m²)
Time frame: Baseline to Week 72
Change in HbA1c from baseline (%)
Time frame: Baseline to Week 72
Percent change from baseline in fasting non-HDL cholesterol
Time frame: Baseline to Week 72
Change in fasting glucose from baseline (mg/dL)
Time frame: Baseline to Week 72
Change in fasting insulin from baseline (pmol/L)
Time frame: Baseline to Week 72
Change in diastolic blood pressure (DBP) from baseline
Time frame: Baseline to Week 72
Percent change in fasting total cholesterol from baseline
Time frame: Baseline to Week 72
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AURORA-1 Clinical Site
Little Rock, Arkansas, United States
NOT_YET_RECRUITINGAURORA-1 Clinical Site
Banning, California, United States
NOT_YET_RECRUITINGAURORA-1 Clinical Site
Chula Vista, California, United States
NOT_YET_RECRUITINGAURORA-1 Clinical Site
Covina, California, United States
NOT_YET_RECRUITINGAURORA-1 Clinical Site
Gardena, California, United States
NOT_YET_RECRUITINGAURORA-1 Clinical Site
La Mesa, California, United States
NOT_YET_RECRUITING...and 112 more locations