Can when you eat change how a diabetes drug works?
NCT ID NCT07801326
First seen Sep 03, 2026 · Last updated Sep 04, 2026 · Updated 1 time
Summary
This trial tests an oral medication called MWN109 in Chinese adults with type 2 diabetes, overweight, or obesity. Researchers want to see if the amount of water taken with the pill and the timing of the next meal change how much drug enters the blood. The study also checks safety and whether the body develops antibodies to the drug. Results will guide how people should take MWN109 in future studies.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- MWN109 tablets, an oral medication for type 2 diabetes and weight management
- What this could lead to
- If successful, this study could help determine the best way to take MWN109, potentially improving its effectiveness and tolerability for managing type 2 diabetes and weight.
- What could go wrong
- This is an early-stage trial focused on drug absorption and safety, not on proving clinical benefit. The results may not lead to a better treatment, and side effects or immune responses could limit its use.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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162 people
The number who actually took part.
- Started
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May 2026
- Finished
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Aug 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 50 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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The First Affiliated Hospital of Yunnan University of Chinese Medicine (Yunnan Provincial Hospital of Traditional Chinese Medicine)
Kunming, Yunnan, China
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Other studies related to the condition(s) this trial covers.
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