Overweight , Obesity, Type 2 Diabetes Mellitus (T2DM)
Conditions
Brief summary
This is a randomized, open-label, multiple-dose study to evaluate the effects of different volumes of administration water, post-dose fasting duration, and high-fat diet on the pharmacokinetics of the 15 mg dose of MWN109 tablets in adult Chinese participants, as well as to assess its safety, tolerability, and immunogenicity. The study consists of two parts. Part 1 is an administration condition study, which includes 6 groups stratified by post-dose fasting duration and administration water volume. Part 2 is a food-effect study, comprising 3 groups stratified by dietary conditions.. A total of 162 participants are planned to be enrolled. The primary endpoint is pharmacokinetics (PK). PK parameters include Cmax, Cmin, AUC0-t, AUC0-∞, Tmax, and t1/2. Secondary endpoints include safety (adverse events \[AEs\] and serious adverse events \[SAEs\]) and immunogenicity (anti-drug antibodies \[ADAs\]).
Interventions
DRUGMWN109 Tablets
administered orally
Sponsors
Shanghai Minwei Biotechnology Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male or female participants aged 18 to 50 years, inclusive, at the time of signing the informed consent form. 2. Body mass index (BMI) = weight (kg) / height squared (m²): 19.0 kg/m² ≤ BMI \< 30.0 kg/m², with a body weight ≥ 55 kg for males or ≥ 50 kg for females.
Exclusion criteria
1. History of severe drug allergy (especially known or suspected allergy to any component or excipient of MWN109 tablets), severe atopic allergic disease/history (e.g., asthma, urticaria, eczematous dermatitis), or a severe allergic constitution. 2. History of acute or chronic pancreatitis, symptomatic gallbladder disease, pancreatic injury, or other high-risk factors that may lead to pancreatitis. 3. History or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2; history of thyroid insufficiency or abnormal thyroid hormone levels. 4. Gastrointestinal diseases at present or at screening that may increase participant risk, such as abnormal gastric emptying (e.g., gastroparesis, pyloric stenosis, pyloric obstruction), severe chronic gastrointestinal diseases (e.g., history of intestinal obstruction, active ulcer within 6 months), previous gastric resection surgery, or gastrointestinal clinical symptoms or signs at screening (e.g., diarrhea, constipation, nausea, vomiting, irregular bowel movements, or alternating diarrhea and constipation) (diarrhea is defined as watery stools and/or ≥ 3 bowel movements per day; constipation is defined as the inability to achieve a bowel movement at least every other day). 5. History of any of the following cardiac diseases within 6 months prior to screening: decompensated cardiac insufficiency (New York Heart Association \[NYHA\] class III or IV); unstable angina, myocardial infarction, coronary artery bypass grafting, or coronary stent implantation. 6. Hemorrhagic or ischemic stroke within 6 months prior to screening, if judged by the investigator to be unsuitable for participation in this clinical trial. 7. Severe hypoglycemia or recurrent symptomatic hypoglycemia (≥ 2 episodes within 6 months) within 6 months prior to screening (e.g., anxiety, dizziness, sweating, tremor, hunger, and poor concentration). 8. Any laboratory finding at screening meeting any of the following criteria: 1. glycated hemoglobin (HbA1c) ≥ 6.5%, or fasting blood glucose (GLU) \> 6.1 mmol/L or \< 3.9 mmol/L. 2. alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin (TBIL) \> 1.5 times the upper limit of normal (ULN). 3. serum creatinine (CR) \> 1.1 times ULN, or estimated glomerular filtration rate (eGFR) \< 80 mL/min/1.73 m2 (CKD-EPI formula), or urine protein (PRO) positive (1+) or above. 4. serum uric acid (UA) \> 540 μmol/L. 5. serum calcitonin (PCT) ≥ 35 ng/L. 6. thyroid-stimulating hormone (TSH) \> 6.0 mIU/L or below the lower limit of normal (LLN). 7. fasting triglycerides (TG) ≥ 3.42 mmol/L. 8. amylase (AMY) \> 1.5 times ULN. 9. hemoglobin (HGB) \< 100 g/L (female) or \< 110 g/L (male). 10. positive for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), or Treponema pallidum antibody (TPAb). 11. 12-lead electrocardiogram (ECG) showing heart rate \< 50 beats/min or \> 90 beats/min, second- or third-degree atrioventricular block, long QT syndrome, or QTcF \> 470 ms (female) or \> 450 ms (male), or other ECG abnormalities judged by the investigator to require drug intervention. 12. positive urine drug abuse screening. 13. positive alcohol breath test. 9. Participation in any drug or medical device clinical trial and receipt of investigational drug or medical device intervention within 3 months prior to screening. 10. Use of any prescription or over-the-counter medication (including chemical drugs, vitamins, herbal medicines, etc.) within 2 weeks prior to dosing. 11. Smoking more than 10 cigarettes per day (including nicotine replacement products) within 3 months prior to screening, or inability to refrain from smoking during the confinement period. 12. Regular alcohol consumption within 3 months prior to screening, i.e., average weekly alcohol intake greater than 14 units of alcohol (1 unit = 17.7 mL of ethanol, i.e., 1 unit = 357 mL of beer with 5% alcohol, or 43 mL of liquor with 40% alcohol, or 147 mL of wine with 12% alcohol), or inability to abstain from alcohol during the trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Elimination Half-Life (t1/2) | From Day 1 to Day 29 | t1/2 of MWN109. |
| Maximum Concentration (Cmax) | From Day 1 to Day 29 | Cmax of MWN109. |
| Minimum Concentration (Cmin) | From Day 1 to Day 29 | Cmin of MWN109. |
| Area Under the Curve From Time 0 to Last Quantifiable Time Point (AUC0-t) | From Day 1 to Day 29 | AUC0-t of MWN109. |
| Area Under the Curve From Time 0 to Infinity (AUC0-inf) | From Day 1 to Day 29 | AUC0-inf of MWN109. |
| Time to Reach Maximum Concentration (Tmax) | From Day 1 to Day 29 | Tmax of MWN109. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events (AEs) | From Day 1 to Day 29 | The incidence of adverse events (AEs) and serious adverse events (SAEs). |
| Anti-Drug Antibody (ADA) | From Day 1 to Day 29 | ADA of MWN109. |
Countries
China
Outcome results
None listed