A Phase III Study to Evaluate the Efficacy and Safety of MDR-001 in Adult Participants With Overweight or Obesity (MOBILE）
NCT ID: NCT07274137
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
738 participants
INTERVENTIONAL
2026-02-28
2027-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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MDR-001 Dose 1
MDR-001
Participants will Receive Small Molecule MDR-001 Tablets Administered Orally
MDR-001 Dose 2
MDR-001
Participants will Receive Small Molecule MDR-001 Tablets Administered Orally
placebo
Placebo
Participants will Receive Placebo
Interventions
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MDR-001
Participants will Receive Small Molecule MDR-001 Tablets Administered Orally
Placebo
Participants will Receive Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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:
1. Approved/unapproved marketed weight-loss drugs: orlistat, sibutramine hydrochloride, phentermine, phentermine-topiramate, naltrexone-amfebutamone, tirzepatide, semaglutide, liraglutide, beinaglutide, phendimetrazine, methylamphetamine, etc.
2. 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.
3. Hypoglycemic drugs, such as metformin, sodium-glucose cotransporter 2 (SGLT2) inhibitors, thiazolidinediones (TZDs) or dipeptidyl peptidase 4 (DPP-4) inhibitors.
4. Systemic steroid therapy (including intravenous, oral, intra-articular).
5. 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.
18 Years
65 Years
ALL
No
Sponsors
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MindRank AI Ltd
INDUSTRY
Responsible Party
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Locations
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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
Huizhou Central People's Hospital
Huizhou, , China
Huizhou Third People's Hospital
Huizhou, , China
Huzhou Central Hospital
Huzhou, , China
Central Hospital Affiliated To Shangdong First Medical University
Jinan, , China
Central Hospital of Jin zhou
Jinzhou, , China
Jingzhou Hospital Affiliated to Yangtze University
Jinzhou, , China
The Third Affiliated Hospital of Jinzhou Medical University
Jinzhou, , China
JiuJiang No.1 people's Hospital
Jiujiang, , China
Lianyungang Hospital of TCM
Lianyungang, , China
Liaocheng People's Hospital
Liaocheng, , China
Loudi Central Hospital
Loudi, , China
The First Affiliated Hospital of Ningbo University
Ningbo, , China
Pingxiang People's Hospital
Pingxiang, , China
Sanya Central Hospital (Hainan Third People's Hospital)
Sanya, , China
Shenyang Fifth People Hospital
Shenyang, , China
Shenyang Sixth People's Hospital
Shenyang, , China
The People's Hospital of liaoning Province
Shenyang, , China
The Second Hospital of Hebei Medical University
Shijia Zhuang, , China
Siping Central People's Hospital
Siping, , China
The First Affiliated Hospital of Soochow University
Suzhou, , China
First Hospital of Shanxi Medical University
Taiyuan, , China
Shanxi Bethune Hospital
Taiyuan, , China
Taizhou Hospital of Zhejiang province
Taizhou, , China
Wuhan Third Hospital•Tongren Hospital of Wuhan University
Wuhan, , China
Xuancheng People's Hospital
Xuancheng, , China
Yichang Central People's Hospital
Yibin, , China
Yichang Central People's Hospital
Yichang, , China
Yueyang Central Hospital
Yueyang, , China
Yueyang People's Hospital
Yueyang, , China
The Second Affiliated Hospital of ZhengzhouUniversity
Zhengzhou, , China
The Third People's Hospital of Zhengzhou
Zhengzhou, , China
Xiangya Hospital Zhuzhou Central South University
Zhuzhou, , China
PKUCare Luzhong Hospital
Zibo, , China
Zibo Central Hospital
Zibo, , China
Zibo Municipal Hospital
Zibo, , China
Countries
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Central Contacts
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Facility Contacts
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Linong Ji
Role: primary
Hanqing Cai
Role: primary
Haifeng Zhou
Role: primary
Xinlan Zhao
Role: primary
Junhua Song
Role: primary
Yan Liu
Role: primary
Xiaojia Lou
Role: primary
Shumei Zhong
Role: primary
Tianrong Pan
Role: primary
Jun Ye
Role: primary
Zhan Lin
Role: primary
Haixia Liu
Role: primary
Jianping Yao
Role: primary
XiaoLin Dong
Role: primary
Xueying Wang
Role: primary
Jiaoe Zeng
Role: primary
Yue Xi
Role: primary
Zhaolan Feng
Role: primary
Lingling Cao
Role: backup
Dongji Wang
Role: primary
Jie Bai
Role: primary
Weiping Sun
Role: primary
Li Li
Role: primary
Yawei Zhang
Role: primary
Ling Lin
Role: primary
Yuzhu Zhao
Role: primary
Xiaomei Wang
Role: primary
Binhong Wen
Role: primary
lihui Zhang
Role: primary
Li Sun
Role: primary
Bimin Shi
Role: primary
Yan Wang
Role: primary
Shiwei Liu
Role: primary
Ting Xu
Role: primary
Jun Wu
Role: primary
Chongbing Huang
Role: primary
Zhaoyang Zeng
Role: primary
Jun Zeng
Role: primary
Lu Xu
Role: primary
Rong Ding
Role: primary
Qingju Li
Role: primary
Junpei Chang
Role: primary
Lihua Zhou
Role: primary
Qun Liu
Role: primary
Xiaodong Zhao
Role: primary
Hongyan Shu
Role: primary
Other Identifiers
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MDR-001-CN-05
Identifier Type: -
Identifier Source: org_study_id