Actively Recruiting
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
Led by MindRank AI Ltd · Updated on 2025-03-07
131
Participants Needed
1
Research Sites
133 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants aged 18 to 55 years at the time of consent
- Body mass index (BMI) between 27 and 45 kg/m2
- For male participants, waist circumference at least 90 cm; for female participants, at least 85 cm
You will not qualify if you...
- Conditions that increase bleeding risk, such as hemorrhoids, acute gastritis, or gastric and duodenal ulcers
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia 2, or hereditary diseases leading to medullary thyroid carcinoma
- History of pancreatitis or symptomatic gallbladder disease
- Serum calcitonin above the upper limit of normal at screening
- Systolic blood pressure over 160 mmHg or diastolic blood pressure over 100 mmHg at screening
- ALT or AST levels more than twice the upper limit of normal at screening
- Fasting triglycerides over 5.7 mmol/L, total cholesterol over 7.75 mmol/L, or LDL cholesterol over 4.9 mmol/L at screening
- Abnormal uric acid levels accompanied by clinical symptoms
- Fasting blood glucose levels over 7 mmol/L
- Creatinine clearance below 60 mL/min at screening
- Significant changes in diet, exercise, or body weight (5% or more) within 3 months before screening
- Clinically significant ECG abnormalities or QTcF values over 450 ms for males or 470 ms for females deemed unsuitable by the investigator for study participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The first hospital of Jilin University
Changchun, Jilin, China
Actively Recruiting
Research Team
R
Ruowen Guo
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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