This is a 12 weeks, multicenter, randomized, double-blind, placebo, parallel-controlled Phase Ib trail comparing the efficacy and safety of MDR-001 tablet versus placebo as an adjunct to a reduced calorie diet and increased physical activity in subjects with overweight or obesity, and to explore the optimal dose selection to support the subsequent Pivotal trial.
Have given written informed consent to participate in this study.
Chinese male or female participants who are aged 18-65 (inclusive) years at the time of signing the ICF.
Pre-diabetes: 6.1 mmol/L (110 mg/dL) ≤ FPG < 7.0 mmol/L (126 mg/dL), and/or 5.7% ≤ HbA1c < 6.5%.
Hypertension: Medically documented history of hypertension, or newly diagnosis of hypertension at screening (systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg, measured at least 3 times on different days).
Obesity secondary to underlying medical conditions or drug therapy, including but not limited to hypercortisolism (e.g., Cushing's syndrome), polycystic ovary syndrome, or obesity due to pituitary/hypothalamic damage; OR weight increase attributable to elevated non-fat mass (e.g., edema) at screening or randomization.
Have diabetes mellitus (including type 1 diabetes, type 2 diabetes, diabetes secondary to pancreatic injury, or other types of diabetes) or diagnosed with type 2 diabetes at screening/randomization, defined as HbA1c ≥ 6.5%, and/or fasting plasma glucose ≥ 7.0 mmol/L (126 mg/dL), and/or random plasma glucose ≥ 11.1 mmol/L (200 mg/dL).
One or more episodes of unexplained hypoglycemic events within 3 months prior to screening, defined as FPG < 2.8 mmol/L (50 mg/dL) and/or presence of clinically significant hypoglycemic symptoms (symptoms of sympathetic activation [e.g., palpitations, anxiety, sweating, dizziness, hand tremble, hunger, etc.] and neuroglycopenic symptoms [e.g., altered consciousness, cognitive impairment, convulsions, and coma]).
History of psychiatric disorders, addictive disorders, or other conditions that may compromise the subject's ability to provide informed consent; OR history of unstable anxiety and/or depression that, in the investigator's judgment, remains clinically significant.
Parallel
MDR-001
DrugOral administration of small molecule MDR-001 tablets
Placebo
DrugAdministered orally placebo
Percent Change in Body Weight From Baseline at Week 12
Percent Change in Body Weight From Baseline at Week 12
Change in Body Weight (kg) from Baseline at Week 12
Percentage of Study Participants Who Achieve ≥5% and ≥10% Body Weight Reduction at Week 12
Change in BMI (kg/m2) from Baseline at Week 12
Change in Waist Circumference from Baseline at Week 12
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This trial is not recruiting at the moment. You can still explore other options:
