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
* 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.
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
Contacts
Primary ContactRuowen Guo
Outcome results
None listed