A Phase III, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Once-Daily Oral ASC30 in Adult Participants With Obesity or Overweight With Type 2 Diabetes Mellitus (AURORA-2)
Ascletis Pharma (China) Co., Limited
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. 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. 2. Have a BMI ≥ 27 kg/m2 at screening. 3. Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight. 4. 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. Exclusion Criteria: 1. Have Type 1 Diabetes Mellitus (T1DM), history of ketoacidosis or hyperosmolar state/coma, or any ot…