Assessing the safety of MDR-001 tablets in healthy and overweight individuals
A Randomized, Double-blind, Placebo-controlled Phase I/IIa Clinical Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of MDR-001 Tablets Administrated Orally in Healthy Participants and Obese/ Overweight Participants
This study tests if MDR-001 tablets are safe for healthy people and those who are overweight or obese by giving them different doses and checking for any side effects.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 131 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | MindRank AI Ltd Industry-sponsored |
| Locations | 1 site (Changchun, Jilin) |
| Trial ID | NCT06778850 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the safety and tolerability of MDR-001 tablets administered in single and multiple ascending doses to both healthy participants and those who are overweight or obese. The study aims to evaluate how the body responds to the medication in these different populations. Participants will be monitored for any adverse effects and overall health outcomes following the administration of the drug. The trial is designed to gather essential data that could inform future studies and potential treatments for obesity.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 55 with a body mass index (BMI) between 27 and 45 kg/m2.
Not a fit: Patients with conditions that increase the risk of bleeding or a history of certain cancers or pancreatitis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new treatment options for individuals struggling with obesity and overweight conditions.
How similar studies have performed: While this approach is being explored in this specific context, similar studies have shown promise in assessing the safety of new treatments for obesity.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants who are aged ≥ 18 and ≤ 55 years at the time of signing the informed consent; no gender restriction. * Participants with 27 ≤ body mass index (BMI) ≤ 45 kg/m2. * For male participants, a waist circumference ≥ 90 cm is required, while female participants ≥ 85 cm. Exclusion Criteria: * Participants with any condition that increases the risk of bleeding, such as hemorrhoids, acute gastritis, or gastric and duodenal ulcers. * Participants with personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia 2 (MEN2), or those with hereditary diseases that easily induce to medullary thyroid carcinoma. * Participants with a history of pancreatitis or symptomatic gallbladder disease. * Serum calcitonin \> ULN at screening. * Participants with systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 100 mmHg at screening. * Participants with ALT \>2 × ULN and /or AST \> 2 × ULN at screening. * Participants whose fasting triglycerides \> 5.7 mmol/L, total cholesterol \> 7.75 mmol/L, low-density lipoprotein cholesterol \> 4.9 mmol/L at screening. * Participants with abnormal uric acid levels accompanied by clinical symptoms (those without clinical symptoms can be included). * Participants with fasting blood glucose levels \> 7 mmol/L. * Participants with creatinine clearance \< 60 mL/min at screening \[calculation formula: CLcr: (140 - age) × weight (kg) / \[72 × 0.0113 × Scr (μmol/L)\], × 0.85 for females\]. * Participants have experienced significant changes in diet or exercise habits or within ≥5% changes in body weight within 3 months prior to screening. * Participants with clinically significant ECG abnormality deemed unsuitable participation for study by the investigator; or with ECG QTcF values \> 450 ms for male participants or \> 470 ms for female participants.
Where this trial is running
Changchun, Jilin
- The first hospital of Jilin University — Changchun, Jilin, China (Recruiting)
Study contacts
- Study coordinator: Ruowen Guo
- Email: ruowen.guo@mindrank.cn
- Phone: +86 0571-85233836
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.