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About
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.
Enrollment
Sex
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Volunteers
Inclusion criteria
Exclusion criteria
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
History of gout within 6 months prior to screening
History of major cardiovascular or cerebrovascular disease within 6 months prior to screening, defined as:1)Acute myocardial infarction (MI), percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG), heart valve repair/replacement, unstable angina, hemorrhagic stroke (stroke), ischemic stroke (including transient ischemic attack [TIA]).2)Congestive heart failure of New York Heart Association (NYHA) class III or IV.3)Severe arrhythmias
History of malignancy within 5 years prior to screening or newly diagnosed malignancy at screening
Have a family or personal history (parents, children, and siblings of medullary thyroid cancer or Multiple Endocrine Neoplasia Syndrome Type 2 .
Abnormal thyroid function tests at screening not adequately controlled by stable medication doses , or thyroid ultrasound at screening showing thyroid nodules classified as Chinese-thyroid imaging-reporting and data system category 4 or higher.
History of significant gastrointestinal disease or gastrointestinal surgery or clinically significant gastric emptying abnormality within 6 months prior to screening.
History of intestinal disorders deemed clinically significant by the investigator, or acute hemorrhoidal episode within 3 months prior to screening.
History of acute or chronic pancreatitis, or abnormally elevated serum amylase or lipase levels at screening.
revious acute or chronic hepatitis, or symptoms and signs of any other liver disease other than non-alcoholic fatty liver disease, or abnormalities in related laboratory tests at screening
Presence of acute or chronic cholecystitis at screening, or symptomatic or treatment-requiring cholelithiasis/gallbladder polyps at screening, or newly diagnosed cholelithiasis within 6 months before screening
Hypersensitivity or suspected hypersensitivity to glucagon-like peptide 1 receptor agonist (GLP-1RA) drugs or excipients.
History of drug abuse or dependence prior to screening.
Have current or history of treatment with medications that may cause significant weight gain within 3 months prior to screening, including but not limited to:
History of bariatric surgery (excluding acupuncture/cupping/catgut embedding for bariatric surgery, liposuction, and abdominoplasty performed >1 year prior to screening) or plans to undergo bariatric surgery or acupuncture/cupping/catgut embedding, liposuction, abdominoplasty during the study period.
Planned chronic use of medications affecting gastrointestinal motility or scheduled gastric emptying-impairing surgery during the study period.
Major or medium-sized surgery, or severe trauma or serious infection within 3 months prior to screening, which, as assessed by the investigator, would preclude trial participation, or planned surgery during the study period (excluding outpatient procedures deemed by the investigator to have no impact on subject safety or trial outcomes).
History of organ transplant.
Use of any drug or food known to potently or moderately inhibit or induce cytochrome P450 3A4 enzyme (CYP3A4) and/or inhibit P-glycoprotein (P-gp) within 28 days prior to the first dose and throughout the study.
Currently participating in any other clinical study, or if received any investigational product or medical devices within ≤ 3 months or 5 half-lives (t1/2) prior to screening, whichever is longer.
Donation or loss of ≥ 400 mL of blood or transfusion/blood products during this period within 3 months prior to screening, or intention to donate blood during the study.
emale participants during pregnancy or lactation.
The investigator, site personnel, and/or their immediate family members directly related to the study. An immediate family member is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
Participants who may be unable to complete this study for other reasons, or have other conditions that, as assessed by the investigator, will make the participant unsuitable for participation in this study, for example, the participant refuses to use only the weight-loss drugs specified in the protocol during the study.
Primary purpose
Allocation
Interventional model
Masking
738 participants in 3 patient groups, including a placebo group
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Central trial contact
Wei N Jia
Data sourced from clinicaltrials.gov
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