NCT07110766
Not yet recruiting
Phase 1
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase Ib Clinical Study to Evaluate the Efficacy and Safety of Small Molecule MDR-001 Tablets Administered Orally for 12 Weeks Treatment in Overweight or Obesity Participants
MindRank AI Ltd1 site in 1 country24 target enrollmentStarted: August 9, 2025Last updated:
Overview
- Phase
- Phase 1
- Status
- Not yet recruiting
- Sponsor
- MindRank AI Ltd
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Percent Change in Body Weight From Baseline at Week 12
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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%.
Exclusion Criteria
- •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.
Arms & Interventions
MDR-001
Experimental
MDR-001 Administered orally
Intervention: MDR-001 (Drug)
Placebo
Experimental
Administered orally placebo
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Percent Change in Body Weight From Baseline at Week 12
Time Frame: Baseline, Week 12
Percent Change in Body Weight From Baseline at Week 12
Secondary Outcomes
- 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 Blood Glucose (HbA1c, FPG) 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)
- Change in Blood Pressure (SBP, DBP) from Baseline at Week 12(Baseline, Week 12)
- Collect the incidence of adverse events (AEs) through vital signs, physical examination, laboratory tests, 12-lead electrocardiogram, etc.(Baseline, Week 13)
Investigators
Study Sites (1)
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