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

Phase 1

Recruiting

• Conditions: Overweight and Obese Volunteers
• Interventions: Drug: MDR-001; Drug: palcebo

• Registration Number: NCT06778850
• Lead Sponsor: MindRank AI Ltd

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-09
• Status Verified: 2025-01
• Study First Submitted: 2025-01-07
• Study First Submitted QC: 2025-01-12
• Study First Posted: 2025-01-16
• Last Update Submitted: 2025-03-05
• Last Update Posted: 2025-03-07
• Primary Completion: 2025-07-15
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 131

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MDR-001（SAD）	MDR-001	Single doses of MDR-001 administered orally.
Placebo (SAD)	palcebo	Placebo administered orally.
MDR-001 (MAD)	MDR-001	Multiple doses of MDR-001 administered orally.
Placebo (MAD)	palcebo	Placebo administered orally.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

The first hospital of Jilin University; 🇨🇳 Changchun, Jilin, China