A Phase III Study to Evaluate the Efficacy and Safety of MDR-001 in Adult Participants With Overweight or Obesity (MOBILE）

Официальное название

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Clinical Study to Evaluate the Efficacy and Safety of MDR-001 Administered Orally Over 52 Weeks in Participants With Overweight or Obesity (MOBILE)

Обзор

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.

Вмешательства

• Препарат MDR-001
  Participants will Receive Small Molecule MDR-001 Tablets Administered Orally
• Препарат Placebo
  Participants will Receive Placebo

Первичные конечные точки

• Percentage change from baseline in body weight (%) at Week 52 [Срок оценки: baseline,Week 52]
• Percentage (%) of participants who achieve≥5% body weight reduction from baseline at Week 52 [Срок оценки: baseline,Week 52]

Вторичные конечные точки (12)

• Change from baseline in body weight (kg) at Week 52 [Срок оценки: baseline,Week 52]
• Percentage (%) of participants who achieve ≥ 10% or ≥ 15% body weight reduction from baseline at Week 52 [Срок оценки: Baseline,Week52]
• Change from baseline in BMI (kg/m2) at Week 52 [Срок оценки: Baseline,Week52]
• Change from baseline in waist circumference (cm) at Week 52 [Срок оценки: Baseline, Week52]
• Change from baseline in hip circumference (cm) at Week 52 [Срок оценки: Baseline,Week 52]
• Change from baseline in waist-hip ratio (%) at Week 52 [Срок оценки: Baseline,Week52]
• Change from baseline in Total cholesterol (TC, mmol/L) at Week 52 [Срок оценки: Baseline, Week 52]
• Change from baseline in Triglycerides (TG, mmol/L) at Week 52 [Срок оценки: baseline,Week 52]
• Change from baseline in Low-density lipoprotein cholesterol (LDL-C, mmol/L) at Week 52 [Срок оценки: baseline,Week 52]
• Change from baseline in High-density lipoprotein cholesterol (HDL-C，mmol/L) at Week 52 [Срок оценки: baseline,Week 52]
• Change from baseline in Non-high-density lipoprotein cholesterol (nHDL-C, mmol/L) at Week 52 [Срок оценки: baseline,Week 52]
• Change from baseline in Lipoprotein (a) (Lp[a], mg/dL) at Week 52 [Срок оценки: baseline，Week 52]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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:

• Approved/unapproved marketed weight-loss drugs: orlistat, sibutramine hydrochloride, phentermine, phentermine-topiramate, naltrexone-amfebutamone, tirzepatide, semaglutide, liraglutide, beinaglutide, phendimetrazine, methylamphetamine, etc.
• Investigational products of weight-loss: Glucagon-like peptide 1 receptor (GLP-1R) agonists, GLP-1R/glucagon receptor (GCGR) agonists, glucose-dependent insulinotropic polypeptide receptor (GIPR)/GLP-1R agonists, GIPR/GLP-1R/GCGR agonists,GLP-1R agonists/activin type II receptor (ActRII) inhibitors, GLP-1R/GIPR/fibroblast growth factor 21 receptor (FGF21R) agonists or FGF21R/GCGR/GLP-1R agonists.
• Hypoglycemic drugs, such as metformin, sodium-glucose cotransporter 2 (SGLT2) inhibitors, thiazolidinediones (TZDs) or dipeptidyl peptidase 4 (DPP-4) inhibitors.
• Systemic steroid therapy (including intravenous, oral, intra-articular).
• Tricyclic antidepressants or other antipsychotic or antiepileptic drugs affecting body weight (e.g., mirtazapine, paroxetine, clozapine, olanzapine, risperidone, quetiapine, paliperidone, valproic acid, valproic acid derivatives, lithium).
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 45 центров

• Peking University People's Hospital — Пекин
• The Second Hospital of Jilin University — Changchun
• The First People's Hospital of Changde City — Changde
• People's Hospital of Hunan Province — Чанша
• The Fourth Hospital of Changsha — Чанша
• The Third People's Hospital of Datong — Datong
• Dongyang People's Hospital — Dongyang
• Ganzhou People's Hospital — Ganzhou
• … и ещё 37 центров

Идентификаторы

NCT: NCT07274137 · MDR-001-CN-05

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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