Clinical trial NCT06778850: 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
Official title: A Randomized, Double-blind, Placebo-controlled Phase I/IIa Clinical Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of MDR-001 Tablets Administrated Orally in Healthy Participants and Obese/ Overweight Participants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Overweight and Obese Volunteers
Lead sponsor: MindRank AI Ltd
Sponsor class: INDUSTRY
First posted: 2025-01-16
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

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.

Primary outcomes:
measure: 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
timeFrame: Baseline through Day 84
Secondary outcomes:
measure: PK: Area Under the Concentration Versus Time Curve (AUC) of MDR-001
timeFrame: Baseline through Day 84
measure: Change from Baseline in Fasting Glucose
timeFrame: Baseline through Day 84
measure: Pharmacokinetics (PK): Maximum Concentration (Cmax) of MDR-001
timeFrame: Baseline through Day 84
measure: Change from Baseline in Glycated Hemoglobin (HbA1c)
timeFrame: Baseline through Day 84
measure: Change from Baseline in Body Weight
timeFrame: Baseline through Day 84
Other outcomes:
Locations:
city: Changchun
country: China
facility: The first hospital of Jilin University
state: Jilin
Study officials:
References: