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A Study to Evaluate the Efficacy and Safety of MDR-001 in Subjects Who Are Obesity or Overweight | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE2

A Study to Evaluate the Efficacy and Safety of MDR-001 in Subjects Who Are Obesity or Overweight

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

NCT06606483•MindRank AI Ltd

View on ClinicalTrials.gov

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 selection to support the subsequent Pivotal trial.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. In accordance with adequate informed consent, the subject voluntarily signs the Informed Consent Form (ICF).
•2. Male or female participants aged ≥18 and ≤ 65 years, who have signed the Informed Consent Form (ICF)
•3. 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).
•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)
•4. 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)
•5. 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.
•6. 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.

Exclusion Criteria

•1. 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
•2. 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).
•3. 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.
•4. A history of psychiatric disorders, addictive diseases, or other conditions that may impair the ability of the participant to provide informed consent.
•5. A history of suicidal ideation or suicidal behavior.
•6. 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
•7. A history of gout within the past six months prior to screening.
•8. A history of proliferative retinopathy or macular degeneration.
•9. 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)
•10. Have a known self or family history (first-degree relative) of medullary thyroid carcinoma or multiple endocrine neoplasia type 2
+22 more criteria

Locations (19)

The Second Hospital Of Anhui Medical University

Hefei, Anhui, China

The People's Hospital of Suancheng City

Xuancheng, Anhui, China

Zibo Central Hospital

Zibo, Anhui, China

Peking University People's Hospital

Beijing, Beijing Municipality, China

The Third People's Hospital of Hainan

Haikou, Hainan, China

The Second Hospital Of Hebe Medical University

Shijiazhuang, Hebei, China

The Fourth Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

The first Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, China

The First Affiliated Hospital of Nanyang Medical College

Nanyang, Henan, China

The First People's Hospital of Chenzhou City

Chenzhou, Hunan, China

Key Dates

Start Date

September 23, 2024

Primary Completion Date

July 30, 2025

Completion Date

September 30, 2025

Last Updated

September 24, 2024

Enrollment

300

ESTIMATED participants

Conditions

ObesityOverweight and Obesity

Interventions

MDR-001

DRUG

Placebo

DRUG

Contacts

Ruowen Guo

CONTACT

+86 0571-85233836 ruowen.guo@mindrank.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 24, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Evaluate the Efficacy and Safety of MDR-001 in Subjects Who Are Obesity or Overweight

Inclusion Criteria

Exclusion Criteria

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