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.
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
Participants who are obesity (BMI ≥ 28.0 kg/m2), or overweight (24.0 kg/m2 ≤ BMI < 28.0 kg/m2) with at least one of the the following weight-related comorbidities at screening:1) Pre-diabetes. 2) Hypertension.3) Dyslipidemia.4) Fatty liver.5) Obstructive sleep apnea syndrome.6) Complaint of weight-bearing joint pain.
Participants had a stable weight maintenance during the 3 months of dietary and physical activity prior to screening (participant-reported data acceptable) and no more than 5% weight fluctuation
Obesity induced by secondary diseases or drug
Have diabetes mellitus
Have any lifetime history of a suicidal attempt or suicidal behavior
Have a history of depressive disorder
Parallel
MDR-001
DrugParticipants will Receive Small Molecule MDR-001 Tablets Administered Orally
Placebo
DrugParticipants will Receive Placebo
Percentage change from baseline in body weight (%) at Week 52
(Week 52 body weight-baseline body weight)/baseline weight
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%
Change from baseline in body weight (kg) at Week 52
Week 52 body weight-baseline body weight
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%
Change from baseline in BMI (kg/m2) at Week 52
BMI (kg/m2) = weight (kg)/height (m)2
Change from baseline in waist circumference (cm) at Week 52
Week 52 waist circumference-baseline waist circumference
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This trial is not recruiting at the moment. You can still explore other options:
