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Recruiting 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

Phase I / Phase II Interventional Overweight and Obese Volunteers

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MDR-001, palcebo.
Who it may be relevant to
Registry conditions: Overweight and Obese Volunteers. Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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

  • Drug MDR-001
    Oral administration of small molecule MDR-001 tablets
  • Drug palcebo
    Administered orally placebo

Primary outcome measures

  • 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 [Time frame: Baseline through Day 84]
Secondary outcome measures (5)
  • PK: Area Under the Concentration Versus Time Curve (AUC) of MDR-001 [Time frame: Baseline through Day 84]
  • Change from Baseline in Fasting Glucose [Time frame: Baseline through Day 84]
  • Pharmacokinetics (PK): Maximum Concentration (Cmax) of MDR-001 [Time frame: Baseline through Day 84]
  • Change from Baseline in Glycated Hemoglobin (HbA1c) [Time frame: Baseline through Day 84]
  • Change from Baseline in Body Weight [Time frame: Baseline through Day 84]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • The first hospital of Jilin University — Changchun

Identifiers

NCT: NCT06778850 · MDR-001-CN-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗