ObesityPhase 2NCT06606483
A Study to Evaluate the Efficacy and Safety of MDR-001 in Subjects Who Are Obesity or Overweight
A Phase 2 study testing MDR-001 in people with Obesity and Overweight and Obesity, run by MindRank AI Ltd at 19 sites in China.
Trial summary
This is a 24 weeks, multicenter, randomized, double-blind, placebo, parallel-controlled Phase IIb trail comparing the efficacy and safety of MDR-001 tablet versus placebo as an adjunct to a reduced calorie diet and increased physical activity in subjects with overweight or obesity, and to explore the optimal dose… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Overweight and 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
- 300 participants
- Where
- 19 sitesChina
- Study dates
- 23 Sep 2024to 30 Sep 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- In accordance with adequate informed consent, the subject voluntarily signs the Informed Consent Form (ICF).
- Male or female participants aged ≥18 and ≤ 65 years, who have signed the Informed Consent Form (ICF)
- Have BMI of
- obesity: ≥28 kg/m2
- overweight: ≥24 kg/m2 and ≤28 kg/m2 with at least 1 of the following weight-related comorbidities
- 1) prediabetes: 6.1 mmol/L (110 mg/dL) ≤FPG≤7.0 mmol/L (126 mg/dL) ; and/or 5.7%≤HbA1c≤6.5% 2）Hypertension: medical record for Hypertension, or diagnosis of hypertension for the first time during screening (with at least three measurements spaced across at least over a period of two days, defining hypertension as a systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg).
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- 3) Dyslipidemia: medical record for dyslipidemia (regardless of medication treatment) or TC≥5.2 mmol/L (200 mg/dl), and/or LDL-C≥3.4 mmol/L (130 mg/dl), and/or HDL-C<1.0 mmol/L (40 mg/d l), and/or TG≥1.7 mmol/L (150 mg/dl) at screening 4) fatty liver disease(FLD): Presence of FLD confirmed by imaging studies within three months prior to screening, or diagnosis of FLD at screening 5) obstructive sleep apnea 6) Presence of weight-bearing joint pain during the screening period or within three months prior to screening. (Acceptance of patient self-description)
- The weight change achieved through dietary and exercise control should not exceed a 5% variation within three months prior to screening. (Acceptance of patient self-description)
- Potential participants with fertility potential (including the partners of male participants) must not have any plans for conception or sperm donation from the screening period until 6 months after the last dose administration, and they should be willing to use at least one effective contraception method.
- The participant must have a thorough understanding of the trial objectives, be able to communicate effectively with the investigators, and be capable of comprehending and adhering to all the requirements of this trial, including following the medication regimen and lifestyle guidance as outlined in the protocol.
Who cannot join
- Have obesity induced by other disorders or drugs, including elevated cortisol hormones (such as Cushing's syndrome), polycystic ovary syndrome, obesity due to pituitary and hypothalamic injuries, etc
- Previous diagnosis of diabetes mellitus (including Type 1 diabetes, Type 2 diabetes, diabetes caused by pancreatic injury, or other types of diabetes) or diagnosis of Type 2 diabetes at the time of screening/randomization, defined as: HbA1c ≥ 6.5%; and/or fasting plasma glucose ≥ 7.0 mmol/L (126 mg/dL); and/or random plasma glucose ≥ 11.1 mmol/L (200 mg/dL).
- A history of at least one episode of hypoglycemia occurring within the 3 months prior to screening, without apparent precipitating causes, is defined as FPG \<2.8 mmol/L (50 mg/dL) and/or the presence of marked symptoms of hypoglycemia.
- A history of psychiatric disorders, addictive diseases, or other conditions that may impair the ability of the participant to provide informed consent.
- A history of suicidal ideation or suicidal behavior.
- Have any of the following major cardiovascular and cerebrovascular conditions within 6 months prior to Screening 1) myocardial infarction(MI), percutaneous coronary intervention(PCI), coronary artery bypass grafting(CABG), heart valve repair/replacement, unstable angina, hemorrhagic stroke (stroke), ischemic stroke (including transient ischemic attack (TIA)); 2) New York Heart Association Functional Classification III or IV congestive heart failure
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- A history of gout within the past six months prior to screening.
- A history of proliferative retinopathy or macular degeneration.
- Have a history of malignancy less than 5 years or diagnosis of malignancy at screening (other than cured basal cell skin cancer, or in situ carcinomas of the cervix)
- Have a known self or family history (first-degree relative) of medullary thyroid carcinoma or multiple endocrine neoplasia type 2
- Have a personal or family history of long QT syndrome, family history of sudden death in a first-degree relative (parents, siblings, or children) before the age of 40 years, and/or a personal history of unexplained syncope within the last year.
- During the screening phase, subjects exhibited thyroid function abnormalities uncontrolled (TSH\>6 mIU/L or \<0.4 mIU/L) by a stable medication regimen (stable dosages for three months or more), Subclinical hypothyroidism requiring no treatment (with TSH levels \<10.0 mIU/L and normal range of FT3 and FT4) is excluded.
- Within the six months preceding screening, subjects experienced severe gastrointestinal disorders (such as active gastric ulcers), or underwent gastrointestinal surgery (Appendectomy, cholecystectomy, or other gastrointestinal endoscopic surgeries deemed by the investigator to have no significant impact on gastrointestinal motility are excluded), or have a known clinically significant gastric emptying abnormality (for example, pyloric obstruction, gastroparesis)
- Amylase/lipase>3 ULN at screening or have had a history of chronic or acute pancreatitis
- Have had a history of chronic or acute hepatitis; or have signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease at screening, or any of the following, as determined by the laboratory during screening 1）ALT or AST ≥3×ULN 2）TBIL≥1.5×ULN 3）ALP≥3×ULN
- Subjects with a history of acute biliary tract disease (cholecystitis, gallstones, or bile duct stones) within one year prior to screening, or suffer from biliary tract disease accompanied by related clinical symptoms which should be treated at screening/randomization, are deemed unsuitable for participation in this clinical trial by the investigator.
- The subjects exhibit hypersensitivity or a suspected hypersensitivity to GLP-1 receptor agonists (GLP-1RAs) or to excipients.
- Have a history of drug or alcohol abuse
- Have a history of alcoholism within the prior 3 months of study screening (750 mL of beer or 250 mL of wine or 50 g of distilled spirits per day)
- Have taken within 3 months prior to screening medications or food intended to affect body weight, including but not limited to:
- 1) Approved/unapproved weight-loss drugs: Orlistat, Sibutramine Hydrochloride, Phentermine Resin Complex, Phentermine-Topiramate, Contrave, Semaglutide, Liraglutide, Phendimetrazine, Methamphetamine, etc.; 2) GLP-1RA or GLP-1R/GCGR or GIPR/GLP-1R or GIPR/GLP-1R/GCGR or DPP-4 inhibitors 3) Hypoglycemic drugs, such as metformin, sodium-glucose cotransporter 2 (SGLT2) inhibitors, thiazolidinediones (TZDs), etc.
- 4) Systemic steroids (including intravenous, oral, intra-articular administration) 5) Tricyclic antidepressants or other antipsychotic or antiepileptic drugs intended to affect body weight (such as: Mirtazapine, Paroxetine, Clozapine, Olanzapine, Risperidone, Paliperidone, Valproic acid, Valproic acid derivatives, lithium salt).
- 21. Have a prior or planned surgical treatment for obesity (excluding acupuncture, cupping, thread lift, liposuction or abdominoplasty, if performed 1 year prior to screening) or planned surgical treatment or acupuncture, cupping, thread lift, liposuction or abdominoplasty during clinical trial 22. Screening within 3 months before the large or medium-sized surgery or serious trauma, severe infection occurred, the investigator judged not suitable for this trial or during the trial period is planned to receive surgery (Outpatient surgeries that are judged by the investigator to have no impact on the safety of the subjects and the results of the trial are excluded) 23. Have had a history of organ transplantation 24. The use of any drugs or foods known to potently or moderately inhibit CYP3A4 and/or P-gp is prohibited within 28 days prior to the first administration of the study drug and throughout the duration of the trial.
- 25. Have poorly controlled hypertension (mean seated systolic BP ≥160 mm Hg or mean seated diastolic BP ≥100 mm Hg) at screening (Pre-randomization review; seated, at rest for at least 5 minutes, with a second measurement taken to average the values if the difference between the two measurements exceeds ≥5 mmHg, with a third measurement taken if necessary, with at least a one-minute interval between each test. The final test result is the arithmetic mean of the three test results) 26. positive HBsAg or HCV antibodies or HIV antibodies or syphilis antibodies at screening 27. During the screening phase, laboratory examination results meet any of the following criteria:
- calcitonin≥50 ng/L
- estimated eGFR ≤60 mL/min/1.73 m2, calculated by CKD-EPI
- uncontrolled severe dyslipidemia, with triglyceride (TG) levels ≥ 5.65 mmol/L (500 mg/dL) treated by conventional lipid-lowering medications.
- INR\>1.5×ULN
- hemoglobin value \<110 g/L (females) or \<120 g/L (males) 28. Screening for QTcF\>450 ms (males) and QTcF\>470 ms (females) at rest (at least 5 min, repeat measurement once to obtain the average, with a 2 min ± 60 s interval between the two measurements).
- 29. Participating in another clinical trial; or, if on treatment with the investigational drug or device, the time since the last dose or cessation of treatment is ≤3 months or 5 half-lives (t1/2) of the investigational drug (whichever is longer) prior to the first day of this trial screening.
- 30. Have a blood transfusion or severe blood loss ≥500 mL within the prior 3 months of study screening or received blood transfusion before screening 31. Pregnant or lactating females; 32. Parties directly associated with this trial, including but not limited to, the principal investigator(s), staff members of the trial centers, and/or their immediate family members. Immediate family members are defined as spouses, parents, children, or siblings, whether born or legally adopted.
- 33. Inability to complete the trial for reasons unrelated to the study, or any other condition or prior therapy that would make the participant unsuitable for this study (such as participant refusal to adhere to the prescribed weight-loss medication exclusively during the trial period).
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
China19 sites
Peking University People's Hospital
Beijing, Beijing Municipality
Linong Ji
Second Hospital of Jilin University
Changchun, Jilin
Hanqing Cai
The First People's Hospital of Chenzhou City
Chenzhou, Hunan
Weihong Song
Daqing People's Hospital
Daqing, Jilin
Yang Liu
The Third People's Hospital of Hainan
Haikou, Hainan
Ling Lin
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang
Zhifeng Cheng
The Second Hospital Of Anhui Medical University
Hefei, Anhui
Tianrong Pan
Central hospital of Jinan
Jinan, Shandong
Xiaolin Dong
The first Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan
Yujin Ma
The First Affiliated Hospital of Nanyang Medical College
Nanyang, Henan
Dexue Liu
Panjin Liaoyou Gem Flower Hospital
Panjin, Liaoning
Xin Zhang
The Fifth People's Hospital of Shenyang
Shenyang, Liaoning
Yuzhu Zhao
The Second Hospital Of Hebe Medical University
Shijiazhuang, Hebei
Shanxi Bethune Hospital
Taiyuan, Shanxi
Shiwei Liu
Xianyan Hospital of Yanan Univisity
Xianyang, Shanxi
Fang Wang
The People's Hospital of Suancheng City
Xuancheng, Anhui
Chongbing Huang
Yichang Central People's Hospital
Yichang, Sichuan
Jun Zeng
Zhuzhou Central Hospital
Zhuzhou, Hunan
Lihua Zhou
Zibo Central Hospital
Zibo, Anhui
Xiaodong Zhao
About this study
Official title: A 24 Weeks, Multicenter, Randomized, Double-blind, Placebo, Parallel-controlled Phase IIb Trail Comparing the Efficacy and Safety of MDR-001 Tablet Versus Placebo in Subjects With Overweight or Obesity
This is a 24 weeks, multicenter, randomized, double-blind, placebo, parallel-controlled Phase IIb trail comparing the efficacy and safety of MDR-001 tablet versus placebo as an adjunct to a reduced calorie diet and increased physical activity in subjects with overweight or obesity, and to explore the optimal dose selection to support the subsequent Pivotal trial.
- Conditions
- Obesity, Overweight and Obesity
- Being tested
- MDR-001, Placebo
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MDR-001Drug
Oral administration of small molecule MDR-001 tablets
PlaceboDrug
Administered orally placebo
| Study group | Role | What they receive |
|---|---|---|
| 90 mg MDR-001 | Experimental | Drug: MDR-001 Administered orally Receives: Drug: MDR-001 |
| 120 mg MDR-001 | Experimental | Drug: MDR-001 Administered orally Receives: Drug: MDR-001 |
| 150 mg MDR-001 | Experimental | Drug: MDR-001 Administered orally Receives: Drug: MDR-001 |
| 180 mg MDR-001 | Experimental | Drug: MDR-001 Administered orally Receives: Drug: MDR-001 |
| placebo | Placebo comparator | Drug: MDR-001 Administered orally Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Body Weight From Baseline at Week 24
Measured: Baseline, Week 24
Secondary outcomes (8)
Change in Body Weight (kg) from Baseline at Week 24
Measured: Baseline, Week 24
Percentage of Study Participants Who Achieve ≥5% Body Weight Reduction at Week 24
Measured: Baseline, Week 24
Percentage of Study Participants Who Achieve ≥10% Body Weight Reduction at Week 24
Measured: Baseline, Week 24
Change in BMI (kg/m2) from Baseline at Week 24
Measured: Baseline, Week 24
Change in Waist Circumference from Baseline at Week 24
Measured: Baseline, Week 24
Change in hyperlipidemia (TC, TG, LDL-C, HDL-C, nHDL-C) From Baseline at Week 24
Measured: Baseline, Week 24
Change in Blood Pressure (SBP, DBP) from Baseline at Week 24
Measured: Baseline, Week 24
Change in Blood Glucose (HbA1c, FPG) from baseline at Week 24
Measured: Baseline, Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start23 Sep 2024 (estimated)
- Primary completion30 Jul 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MindRank AI Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06606483
- Sponsor's protocol ID
- MDR-001-CN-02
- Status last verified
- Sep 2024
- First submitted
- 16 Sep 2024
- Last updated
- 24 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 24 Weeks, Multicenter, Randomized, Double-blind, Placebo, Parallel-controlled Phase IIb Trail Comparing the Efficacy and Safety of MDR-001 Tablet Versus Placebo in Subjects With Overweight or Obesity
- ClinicalTrials.gov ID
- NCT06606483
- Acronym / sponsor ID
- MDR-001-CN-02
- Conditions
- Obesity, Overweight and Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- MindRank AI LtdIndustry (pharma, biotech, devices)
- Study start
- 23 Sep 2024 (estimated)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 23 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a 24 weeks, multicenter, randomized, double-blind, placebo, parallel-controlled Phase IIb trail comparing the efficacy and safety of MDR-001 tablet versus placebo as an adjunct to a reduced calorie diet and increased physical activity in subjects with overweight or obesity, and to explore the optimal dose selection to support the subsequent Pivotal trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 90 mg MDR-001 | Experimental | Drug: MDR-001Drug: MDR-001 Administered orally |
| 120 mg MDR-001 | Experimental | Drug: MDR-001Drug: MDR-001 Administered orally |
| 150 mg MDR-001 | Experimental | Drug: MDR-001Drug: MDR-001 Administered orally |
| 180 mg MDR-001 | Experimental | Drug: MDR-001Drug: MDR-001 Administered orally |
| placebo | Placebo comparator | Drug: PlaceboDrug: MDR-001 Administered orally |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- In accordance with adequate informed consent, the subject voluntarily signs the Informed Consent Form (ICF).
- Male or female participants aged ≥18 and ≤ 65 years, who have signed the Informed Consent Form (ICF)
- Have BMI of
- 1) prediabetes: 6.1 mmol/L (110 mg/dL) ≤FPG≤7.0 mmol/L (126 mg/dL) ; and/or 5.7%≤HbA1c≤6.5% 2）Hypertension: medical record for Hypertension, or diagnosis of hypertension for the first time during screening (with at least three measurements spaced across at least over a period of two days, defining hypertension as a systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg).
- 3) Dyslipidemia: medical record for dyslipidemia (regardless of medication treatment) or TC≥5.2 mmol/L (200 mg/dl), and/or LDL-C≥3.4 mmol/L (130 mg/dl), and/or HDL-C<1.0 mmol/L (40 mg/d l), and/or TG≥1.7 mmol/L (150 mg/dl) at screening 4) fatty liver disease(FLD): Presence of FLD confirmed by imaging studies within three months prior to screening, or diagnosis of FLD at screening 5) obstructive sleep apnea 6) Presence of weight-bearing joint pain during the screening period or within three months prior to screening. (Acceptance of patient self-description)
Key exclusion criteria (32 listed)
- Have obesity induced by other disorders or drugs, including elevated cortisol hormones (such as Cushing's syndrome), polycystic ovary syndrome, obesity due to pituitary and hypothalamic injuries, etc
- Previous diagnosis of diabetes mellitus (including Type 1 diabetes, Type 2 diabetes, diabetes caused by pancreatic injury, or other types of diabetes) or diagnosis of Type 2 diabetes at the time of screening/randomization, defined as: HbA1c ≥ 6.5%; and/or fasting plasma glucose ≥ 7.0 mmol/L (126 mg/dL); and/or random plasma glucose ≥ 11.1 mmol/L (200 mg/dL).
- A history of at least one episode of hypoglycemia occurring within the 3 months prior to screening, without apparent precipitating causes, is defined as FPG \<2.8 mmol/L (50 mg/dL) and/or the presence of marked symptoms of hypoglycemia.
- A history of psychiatric disorders, addictive diseases, or other conditions that may impair the ability of the participant to provide informed consent.
- A history of suicidal ideation or suicidal behavior.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MDR-001Oral administration of small molecule MDR-001 tablets | Drug | 120 mg MDR-001, 150 mg MDR-001, 180 mg MDR-001, 90 mg MDR-001 |
| PlaceboAdministered orally placebo | Drug | placebo |
Primary outcome
Percent Change in Body Weight From Baseline at Week 24
Time frame: Baseline, Week 24
8 secondary outcomes
Change in Body Weight (kg) from Baseline at Week 24
Time frame: Baseline, Week 24
Percentage of Study Participants Who Achieve ≥5% Body Weight Reduction at Week 24
Time frame: Baseline, Week 24
Percentage of Study Participants Who Achieve ≥10% Body Weight Reduction at Week 24
Time frame: Baseline, Week 24
Change in BMI (kg/m2) from Baseline at Week 24
Time frame: Baseline, Week 24
Change in Waist Circumference from Baseline at Week 24
Time frame: Baseline, Week 24
Change in hyperlipidemia (TC, TG, LDL-C, HDL-C, nHDL-C) From Baseline at Week 24
Time frame: Baseline, Week 24
Change in Blood Pressure (SBP, DBP) from Baseline at Week 24
Time frame: Baseline, Week 24
Change in Blood Glucose (HbA1c, FPG) from baseline at Week 24
Time frame: Baseline, Week 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MDR-001 in people with Obesity and Overweight and Obesity, run by MindRank AI Ltd at 19 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 10 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: status not confirmed, as of the sponsor's last update on 24 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ruowen Guo (+86 0571-85233836, ruowen.guo@mindrank.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change in Body Weight From Baseline at Week 24 (time frame: Baseline, Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Sep 2024; AzTrials last refreshed its copy on 6 Nov 2026.