This is a multicenter, randomized, double-blind, placebo-controlled, phase III clinical study to evaluate the efficacy and safety of the oral small molecule MDR-001 Tablets over 52 weeks as an adjunct to a lifestyle intervention in participants with overweight or obesity.The goal of this clinical trial is to determine whether the oral drug MDR-001 can improve weight management in adult participants with overweight or obesity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
738
Percentage change from baseline in body weight (%) at Week 52
(Week 52 body weight-baseline body weight)/baseline weight
Time frame: baseline,Week 52
Percentage (%) of participants who achieve≥5% body weight reduction from baseline at Week 52
(Week 52 body weight-baseline body weight)/baseline body weight, who achieve≥5%
Time frame: baseline,Week 52
Change from baseline in body weight (kg) at Week 52
Week 52 body weight-baseline body weight
Time frame: baseline,Week 52
Percentage (%) of participants who achieve ≥ 10% or ≥ 15% body weight reduction from baseline at Week 52
(Week 52 body weight-baseline body weight)/baseline body weight, who achieve≥ 10% or ≥ 15%
Time frame: Baseline,Week52
Change from baseline in BMI (kg/m2) at Week 52
BMI (kg/m2) = weight (kg)/height (m)2
Time frame: Baseline,Week52
Change from baseline in waist circumference (cm) at Week 52
Week 52 waist circumference-baseline waist circumference
Time frame: Baseline, Week52
Change from baseline in hip circumference (cm) at Week 52
Week 52 hip circumference-baseline hip circumference
Time frame: Baseline,Week 52
Change from baseline in waist-hip ratio (%) at Week 52
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Peking University People's Hospital
Beijing, China
The Second Hospital of Jilin University
Changchun, China
The First People's Hospital of Changde City
Changde, China
People's Hospital of Hunan Province
Changsha, China
The Fourth Hospital of Changsha
Changsha, China
The Third People's Hospital of Datong
Datong, China
Dongyang People's Hospital
Dongyang, China
Ganzhou People's Hospital
Ganzhou, China
The Second Hospital of Anhui Medical University
Hefei, China
The SecondPeople's Hospital of Hefei
Hefei, China
...and 35 more locations
Waist-to-hip ratio = waist circumference (cm) / hip circumference (cm)
Time frame: Baseline,Week52
Change from baseline in Total cholesterol (TC, mmol/L) at Week 52
Week 52 Total cholesterol-baseline Total cholesterol
Time frame: Baseline, Week 52
Change from baseline in Triglycerides (TG, mmol/L) at Week 52
Week 52 Triglycerides-baseline Triglycerides
Time frame: baseline,Week 52
Change from baseline in Low-density lipoprotein cholesterol (LDL-C, mmol/L) at Week 52
Week 52 Low-density lipoprotein cholesterol-baseline Low-density lipoprotein cholesterol
Time frame: baseline,Week 52
Change from baseline in High-density lipoprotein cholesterol (HDL-C,mmol/L) at Week 52
Week 52 High-density lipoprotein cholesterol-baseline High-density lipoprotein cholesterol
Time frame: baseline,Week 52
Change from baseline in Non-high-density lipoprotein cholesterol (nHDL-C, mmol/L) at Week 52
Week 52 Non-high-density lipoprotein cholesterol-baseline Non-high-density lipoprotein cholesterol
Time frame: baseline,Week 52
Change from baseline in Lipoprotein (a) (Lp[a], mg/dL) at Week 52
Week 52 Lipoprotein -baseline Lipoprotein
Time frame: baseline,Week 52
Change from baseline in Systolic blood pressure (SBP, mmHg) at Week 52
Week 52 Systolic blood pressure-baseline Systolic blood pressure
Time frame: baseline,Week 52
Change from baseline in Diastolic blood pressure (DBP, mmHg) at Week 52
Week 52 Diastolic blood pressure-baseline Diastolic blood pressure
Time frame: baseline,Week 52
Change from baseline in Glycosylated hemoglobin (HbA1c, %) at Week 52
Week 52 Glycosylated hemoglobin-baseline Glycosylated hemoglobin
Time frame: baseline,Week 52
Change from baseline in Fasting plasma glucose (FPG, mmol/L) at Week 52
Week 52 Fasting plasma glucose-baseline Fasting plasma glucose
Time frame: baseline,Week 52
Adverse events
Number of participants with treatment-related adverse events as assessed by mild, moderate and severe
Time frame: baseline,Week 52