NCT06778850 A Phase I/IIa Clinical Study to Assess the Single and Multiple Ascending Doses of MDR-001 Tablets in Healthy Participants and Obese/ Overweight Participants
| NCT ID | NCT06778850 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | MindRank AI Ltd |
| Condition | Overweight and Obese Volunteers |
| Study Type | INTERVENTIONAL |
| Enrollment | 131 participants |
| Start Date | 2023-06-09 |
| Primary Completion | 2025-07-15 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 131 participants in total. It began in 2023-06-09 with a primary completion date of 2025-07-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
To investigate the safety and tolerability after single and multiple ascending doses of MDR-001 Tablets administered orally in healthy participants and obese/ overweight participants.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06778850 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 55 Years, studying Overweight and Obese Volunteers. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06778850 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06778850 currently recruiting?
Yes, NCT06778850 is actively recruiting participants. Contact the research team at ruowen.guo@mindrank.cn for enrollment information.
Where is the NCT06778850 trial being conducted?
This trial is being conducted at Changchun, China.
Who is sponsoring the NCT06778850 clinical trial?
NCT06778850 is sponsored by MindRank AI Ltd. The trial plans to enroll 131 participants.