This randomized, double-blind, placebo-controlled phase IIa study is designed to evaluate the efficacy, safety, and tolerability of ASC30 Tablets and ASC30 Tablets A1.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
125
Drug: ASC30 tablets or ASC30 tablets A1 administered orally daily Drug: Placebo administered orally daily
Ascletis Clinical Site
Rogers, Arkansas, United States
Ascletis Clinical Site
Fort Myers, Florida, United States
Ascletis Clinical Site
Miami, Florida, United States
Ascletis Clinical Site
Columbus, Ohio, United States
Percent change in body weight from Baseline up to Week 13
Time frame: Baseline and Week 13
Change in body weight (absolute) from Baseline up to Week 13
Time frame: Baseline and Week 13
Change in waist circumference from Baseline up to Week 13
Time frame: Baseline and Week 13
Change in body mass index from Baseline to Week 13
Time frame: Baseline and Week 13
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Time frame: Baseline and Week 13
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Ascletis Clinical Site
Bellaire, Texas, United States
Ascletis Clinical Site
San Antonio, Texas, United States