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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
1,560
ASC30 tablets A1 administered orally once daily.
Matching placebo tablets administered orally once daily.
AURORA-2 Clinical Site
Birmingham, Alabama, United States
NOT_YET_RECRUITINGAURORA-2 Clinical Site
Huntsville, Alabama, United States
NOT_YET_RECRUITINGAURORA-2 Clinical Site
Peoria, Arizona, United States
NOT_YET_RECRUITINGAURORA-2 Clinical Site
Phoenix, Arizona, United States
RECRUITINGPercent change from baseline in body weight
Time frame: Baseline to Week 72
Change from baseline in HbA1c (%)
Time frame: Baseline to Week 72
Change from baseline in fasting serum glucose (mg/dL)
Time frame: Baseline to Week 72
Change from baseline in systolic blood pressure (SBP) (mmHg)
Time frame: Baseline to Week 72
Percent change from baseline in fasting non-HDL cholesterol
Time frame: Baseline to Week 72
Percent change from baseline in fasting triglycerides
Time frame: Baseline to Week 72
Change from baseline in BMI (kg/m²)
Time frame: Baseline to Week 72
Change from baseline in fasting insulin (pmol/L)
Time frame: Baseline to Week 72
Change from baseline in waist circumference (cm)
Time frame: Baseline to Week 72
Change from baseline in diastolic blood pressure (DBP) (mmHg)
Time frame: Baseline to Week 72
Percent change from baseline in fasting total cholesterol
Time frame: Baseline to Week 72
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AURORA-2 Clinical Site
Tucson, Arizona, United States
NOT_YET_RECRUITINGAURORA-2 Clinical Site
Little Rock, Arkansas, United States
NOT_YET_RECRUITINGAURORA-2 Clinical Site
Banning, California, United States
NOT_YET_RECRUITINGAURORA-2 Clinical Site
Chula Vista, California, United States
NOT_YET_RECRUITINGAURORA-2 Clinical Site
Covina, California, United States
NOT_YET_RECRUITINGAURORA-2 Clinical Site
Gardena, California, United States
NOT_YET_RECRUITING...and 125 more locations