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Overweight or ObesityPhase 3NCT07274137

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

A Phase 3 study testing MDR-001 in people with Overweight or Obesity, run by MindRank AI Ltd at 45 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Overweight or Obesity
What is being tested?
MDR-001
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
738 participants
Where
45 sitesChina
Study dates
Feb 2026to Jul 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

45 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Wei N Jia contact

18019055108

weina.jia@mindrank.cn

45 sites in 1 country

China45 sites

  • Peking University People's Hospital

    Beijing

    Linong Ji

  • The Second Hospital of Jilin University

    Changchun

    Hanqing Cai

  • The First People's Hospital of Changde City

    Changde

    Haifeng Zhou

  • People's Hospital of Hunan Province

    Changsha

    Xinlan Zhao

  • The Fourth Hospital of Changsha

    Changsha

    Junhua Song

  • The Third People's Hospital of Datong

    Datong

    Yan Liu

  • Dongyang People's Hospital

    Dongyang

    Xiaojia Lou

  • Ganzhou People's Hospital

    Ganzhou

    Shumei Zhong

  • The Second Hospital of Anhui Medical University

    Hefei

    Tianrong Pan

  • The SecondPeople's Hospital of Hefei

    Hefei

    Jun Ye

  • Huizhou Central People's Hospital

    Huizhou

    Zhan Lin

  • Huizhou Third People's Hospital

    Huizhou

    Haixia Liu

  • Huzhou Central Hospital

    Huzhou

    Jianping Yao

  • Central Hospital Affiliated To Shangdong First Medical University

    Jinan

    XiaoLin Dong

  • Central Hospital of Jin zhou

    Jinzhou

    Xueying Wang

  • Jingzhou Hospital Affiliated to Yangtze University

    Jinzhou

    Jiaoe Zeng

  • The Third Affiliated Hospital of Jinzhou Medical University

    Jinzhou

    Yue Xi

  • JiuJiang No.1 people's Hospital

    Jiujiang

    Zhaolan Feng

    Lingling Cao

  • Lianyungang Hospital of TCM

    Lianyungang

    Dongji Wang

  • Liaocheng People's Hospital

    Liaocheng

    Jie Bai

  • Loudi Central Hospital

    Loudi

    Weiping Sun

  • The First Affiliated Hospital of Ningbo University

    Ningbo

    Li Li

  • Pingxiang People's Hospital

    Pingxiang

    Yawei Zhang

  • Sanya Central Hospital (Hainan Third People's Hospital)

    Sanya

    Ling Lin

  • Shenyang Fifth People Hospital

    Shenyang

    Yuzhu Zhao

  • Shenyang Sixth People's Hospital

    Shenyang

    Xiaomei Wang

  • The People's Hospital of liaoning Province

    Shenyang

    Binhong Wen

  • The Second Hospital of Hebei Medical University

    Shijia Zhuang

    lihui Zhang

  • Siping Central People's Hospital

    Siping

    Li Sun

  • The First Affiliated Hospital of Soochow University

    Suzhou

    Bimin Shi

  • First Hospital of Shanxi Medical University

    Taiyuan

    Yan Wang

  • Shanxi Bethune Hospital

    Taiyuan

    Shiwei Liu

  • Taizhou Hospital of Zhejiang province

    Taizhou

    Ting Xu

  • Wuhan Third Hospital•Tongren Hospital of Wuhan University

    Wuhan

    Jun Wu

  • Xuancheng People's Hospital

    Xuancheng

    Chongbing Huang

  • Yichang Central People's Hospital

    Yibin

    Zhaoyang Zeng

  • Yichang Central People's Hospital

    Yichang

    Jun Zeng

  • Yueyang Central Hospital

    Yueyang

    Lu Xu

  • Yueyang People's Hospital

    Yueyang

    Rong Ding

  • The Second Affiliated Hospital of ZhengzhouUniversity

    Zhengzhou

    Qingju Li

  • The Third People's Hospital of Zhengzhou

    Zhengzhou

    Junpei Chang

  • Xiangya Hospital Zhuzhou Central South University

    Zhuzhou

    Lihua Zhou

  • PKUCare Luzhong Hospital

    Zibo

    Qun Liu

  • Zibo Central Hospital

    Zibo

    Xiaodong Zhao

  • Zibo Municipal Hospital

    Zibo

    Hongyan Shu

Other trials in China

About this study

Official title: 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)

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.

Being tested
MDR-001, Placebo
Medical subject headings
Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MDR-001Drug

    Participants will Receive Small Molecule MDR-001 Tablets Administered Orally

  • PlaceboDrug

    Participants will Receive Placebo

Study groups in NCT07274137
Study groupRoleWhat they receive
MDR-001 Dose 1ExperimentalNot described
Receives: Drug: MDR-001
MDR-001 Dose 2ExperimentalNot described
Receives: Drug: MDR-001
placeboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage change from baseline in body weight (%) at Week 52

    (Week 52 body weight-baseline body weight)/baseline weight

    Measured: baseline,Week 52

  2. 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%

    Measured: baseline,Week 52

Secondary outcomes (17)

  1. Change from baseline in body weight (kg) at Week 52

    Week 52 body weight-baseline body weight

    Measured: baseline,Week 52

  2. 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%

    Measured: Baseline,Week52

  3. Change from baseline in BMI (kg/m2) at Week 52

    BMI (kg/m2) = weight (kg)/height (m)2

    Measured: Baseline,Week52

  4. Change from baseline in waist circumference (cm) at Week 52

    Week 52 waist circumference-baseline waist circumference

    Measured: Baseline, Week52

  5. Change from baseline in hip circumference (cm) at Week 52

    Week 52 hip circumference-baseline hip circumference

    Measured: Baseline,Week 52

  6. Change from baseline in waist-hip ratio (%) at Week 52

    Waist-to-hip ratio = waist circumference (cm) / hip circumference (cm)

    Measured: Baseline,Week52

  7. Change from baseline in Total cholesterol (TC, mmol/L) at Week 52

    Week 52 Total cholesterol-baseline Total cholesterol

    Measured: Baseline, Week 52

  8. Change from baseline in Triglycerides (TG, mmol/L) at Week 52

    Week 52 Triglycerides-baseline Triglycerides

    Measured: baseline,Week 52

  9. 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

    Measured: baseline,Week 52

  10. 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

    Measured: baseline,Week 52

  11. 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

    Measured: baseline,Week 52

  12. Change from baseline in Lipoprotein (a) (Lp[a], mg/dL) at Week 52

    Week 52 Lipoprotein -baseline Lipoprotein

    Measured: baseline，Week 52

  13. Change from baseline in Systolic blood pressure (SBP, mmHg) at Week 52

    Week 52 Systolic blood pressure-baseline Systolic blood pressure

    Measured: baseline，Week 52

  14. Change from baseline in Diastolic blood pressure (DBP, mmHg) at Week 52

    Week 52 Diastolic blood pressure-baseline Diastolic blood pressure

    Measured: baseline，Week 52

  15. Change from baseline in Glycosylated hemoglobin (HbA1c, %) at Week 52

    Week 52 Glycosylated hemoglobin-baseline Glycosylated hemoglobin

    Measured: baseline，Week 52

  16. Change from baseline in Fasting plasma glucose (FPG, mmol/L) at Week 52

    Week 52 Fasting plasma glucose-baseline Fasting plasma glucose

    Measured: baseline，Week 52

  17. Adverse events

    Number of participants with treatment-related adverse events as assessed by mild, moderate and severe

    Measured: baseline，Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2025
  2. Study startFeb 2026 (estimated)
  3. Primary completionJun 2027 (estimated)
  4. Study completionJul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
738 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07274137
Sponsor's protocol ID
MDR-001-CN-05
Status last verified
Nov 2025
First submitted
18 Nov 2025
Last updated
22 Dec 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MDR-001 in people with Overweight or Obesity, run by MindRank AI Ltd at 45 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Wei N Jia (18019055108, weina.jia@mindrank.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage change from baseline in body weight (%) at Week 52 (time frame: baseline,Week 52). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07274137.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025; AzTrials last refreshed its copy on 1 Nov 2026.

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