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
Recruiting
Phase 1Phase 2Interventional Study
Overweight and Obese Volunteers
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 55
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
131 (estimated)
Sponsor
MindRank AI Ltd · Industry
Who this trial is looking for
This trial is looking for healthy adults and overweight or obese individuals to test the safety of MDR-001 tablets. Participants will take the tablets either once or multiple times.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 18 and 55 years old.
I have a body mass index (BMI) between 27 and 45.
My waist circumference is at least 90 cm if I am male or 85 cm if I am female.
You may not be able to join if
I have a condition that increases the risk of bleeding.
I have a personal or family history of certain types of thyroid cancer.
I have a history of pancreatitis or gallbladder disease.
My blood pressure is too high.
I have abnormal liver enzyme levels.
My fasting triglycerides or cholesterol levels are too high.
I have high fasting blood glucose levels.
I have had significant changes in my diet or exercise in the last 3 months.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
Sorted by distance from Kentucky
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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.
…
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.
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