Phase Ib Clinical Study on the Efficacy and Safety of MDR-001 in Patients Who Are Obesity or Overweight

NCT07110766 | Not Yet Recruiting Phase 1

• 1 other identifier: MDR-001-CN-04
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This is a 12 weeks, multicenter, randomized, double-blind, placebo, parallel-controlled Phase Ib 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 &Amp; Overweight

Outcome Measures

Primary Outcomes (1)

• Percent Change in Body Weight From Baseline at Week 12

  Percent Change in Body Weight From Baseline at Week 12

  Baseline, Week 12

Secondary Outcomes (8)

• Change in Body Weight (kg) from Baseline at Week 12

  Baseline, Week 12

• Percentage of Study Participants Who Achieve ≥5% and ≥10% Body Weight Reduction at Week 12

  Baseline, Week 12

• Change in BMI (kg/m2) from Baseline at Week 12

  Baseline, Week 12

• Change in Waist Circumference from Baseline at Week 12

  Baseline, Week 12

• Change in hyperlipidemia (TC, TG, LDL-C, HDL-C, nHDL-C) From Baseline at Week 12

  Baseline, Week 12

Study Arms (2)

MDR-001

EXPERIMENTAL

MDR-001 Administered orally

Drug: MDR-001

Placebo

EXPERIMENTAL

Administered orally placebo

Drug: Placebo

Interventions

MDR-001 DRUG

Oral administration of small molecule MDR-001 tablets

MDR-001

Placebo DRUG

Administered orally placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 following weight-related comorbidities at screening:
• Pre-diabetes: 6.1 mmol/L (110 mg/dL) ≤ FPG \< 7.0 mmol/L (126 mg/dL), and/or 5.7% ≤ HbA1c \< 6.5%.
• Hypertension: Medically documented history of hypertension, or newly diagnosis of hypertension at screening (systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg, measured at least 3 times on different days).
• Dyslipidemia: Medically documented history of dyslipidemia (with or without medication), or at screening 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/dl), and/or TG ≥ 1.7 mmol/L (150 mg/dl).
• Fatty liver disease: Evidence of fatty liver confirmed by imaging within 3 months prior to screening or newly diagnosed at screening.
• Obstructive sleep apnea syndrome.
• Complaint of weight-bearing joint pain (during or within 3 months prior to screening).
• 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, which is calculated as: (maximum weight - minimum weight during the 3 months of dietary and exercise control prior to screening)/maximum weight \*100%.
• Female participants of childbearing potential (including female partners of male participants) who have no plans to father a child or donate sperm from screening until 6 months after the last dose, and are willing to use at least one effective contraception.
• Participants who well understand the study objectives, can communicate well with the investigator and to understand and comply with the requirements of this study, such as following the protocol medication and lifestyle intervention.

You may not qualify if:

• Obesity secondary to underlying medical conditions or drug therapy, including but not limited to hypercortisolism (e.g., Cushing's syndrome), polycystic ovary syndrome, or obesity due to pituitary/hypothalamic damage; OR weight increase attributable to elevated non-fat mass (e.g., edema) at screening or randomization.
• Have diabetes mellitus (including type 1 diabetes, type 2 diabetes, diabetes secondary to pancreatic injury, or other types of diabetes) or diagnosed with type 2 diabetes at 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).
• One or more episodes of unexplained hypoglycemic events within 3 months prior to screening, defined as FPG \< 2.8 mmol/L (50 mg/dL) and/or presence of clinically significant hypoglycemic symptoms (symptoms of sympathetic activation \[e.g., palpitations, anxiety, sweating, dizziness, hand tremble, hunger, etc.\] and neuroglycopenic symptoms \[e.g., altered consciousness, cognitive impairment, convulsions, and coma\]).
• History of psychiatric disorders, addictive disorders, or other conditions that may compromise the subject's ability to provide informed consent; OR history of unstable anxiety and/or depression that, in the investigator's judgment, remains clinically significant.
• Have any lifetime history of a suicidal attempt or suicidal behavior.
• History of major cardiovascular or cerebrovascular disease within 6 months prior to screening, defined as:
• 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 \[TIA\]).
• Congestive heart failure of New York Heart Association (NYHA) class III or IV.
• History of cardiac arrhythmias, including torsades de pointes, ventricular tachycardia, or second- or third-degree atrioventricular block.
• Have a family or personal history of long QT syndrome, or family history of sudden death in first-degree relatives (parent, child, sibling) before the age of 40 years, and/or personal history of unexplained syncope within 1 year prior to screening.
• History of gout within 6 months prior to screening.
• History of proliferative retinal disease or maculopathy.
• History of malignancy within 5 years prior to screening (except cured basal cell carcinoma of skin and cervical carcinoma in situ) or newly diagnosed malignancy at screening.
• Have a family or personal history (parents, children, and siblings) of medullary thyroid cancer (MTC) or Multiple Endocrine Neoplasia Syndrome Type 2 (MEN2).
• Abnormal thyroid function tests at screening (thyroid-stimulating hormone \[TSH\] \> 6 mIU/L or \< 0.4 mIU/L) not adequately controlled by stable medication doses (defined as stable dosage for ≥3 months), untreated subclinical hypothyroidism (TSH \<10.0 mIU/L with normal free T3 \[FT3\] and free T4 \[FT4\] levels) is permitted.

Sponsors & Collaborators

• MindRank AI Ltd: lead

Study Sites (1)

The first hospital of Jilin University

Ch’ang-ch’un, Jilin, China

Location

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ruowen Guo

CONTACT

+8617321112273; ruowen.guo@mindrank.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2025
• First Posted: August 8, 2025
• Study Start: August 9, 2025
• Primary Completion: September 15, 2025
• Study Completion: October 30, 2025
• Last Updated: August 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)