Overweight and Obese Volunteers
Conditions
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.
Interventions
Sponsors
MindRank AI Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Main inclusion criteria: * Participants who are aged ≥ 18 and ≤ 55 years at the time of signing the informed consent, no gender restriction. * Participants with body weight ≥ 50 kg for males, and ≥ 45 kg for females; 18 ≤ body mass index (BMI) \< 25 kg/m2 for healthy participants, and 25 ≤ BMI ≤ 35 kg/m2 for obese/overweight participants. * For healthy participants, physical examination and vital signs must be normal, or abnormal but clinically insignificant. For obese/overweight participants, physical examination and vital signs must be normal, or abnormal but clinically insignificant, and the vital signs should be within following ranges: systolic blood pressure: 90-150 mmHg; diastolic blood pressure: 50-95 mmHg. Main
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. * Participants with serum calcitonin levels above the upper limit of normal (ULN) at screening. * Participants with significant changes in diet or exercise habits within 3 months prior to screening. * Participants with clinically significant electrocardiogram abnormality; or ECG QTcF values \> 450 ms for males or \> 470 ms for females. * Participants with clinically significant abnormalities in laboratory examinations (obese/overweight participants with triglycerides ≤ 5.7 mmol/L, total cholesterol ≤ 7.75 mmol/L, low-density lipoprotein cholesterol ≤ 4.9 mmol/L, and fasting blood glucose ≤ 7 mmol/L can be included); or those with clinically significant findings indicating the following diseases within 12 months prior to screening, including but not limited to disorders of respiratory system, circulatory system, digestive system, endocrine system, rheumatological/immune system, nervous system, and blood system, and mental/psychological disorders, which are considered by the investigator as inappropriate for participation in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | Baseline through Day 84 | A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PK: Area Under the Concentration Versus Time Curve (AUC) of MDR-001 | Baseline through Day 84 | PK: AUC of MDR-001 |
| Change from Baseline in Fasting Glucose | Baseline through Day 84 | Change from Baseline in Fasting Glucose |
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of MDR-001 | Baseline through Day 84 | PK: Cmax of MDR-001 |
| Change from Baseline in Glycated Hemoglobin (HbA1c) | Baseline through Day 84 | Change from Baseline in HbA1c |
| Change from Baseline in Body Weight | Baseline through Day 84 | Change from Baseline in Body Weight |
Countries
China
Outcome results
None listed