Type 2 Diabetes Mellitus (T2DM)Phase 1NCT07801326
A Study to Evaluate Different Administration Conditions and the Food Effect of MWN109 Tablets in Chinese Participants
A Phase 1 study testing MWN109 Tablets in people with Type 2 Diabetes Mellitus (T2DM) and Overweight , Obesity, run by Shanghai Minwei Biotechnology Co., Ltd at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM), Overweight , Obesity
- What is being tested?
- MWN109 Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteChina
- Study dates
- 24 May 2026to 10 Aug 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female participants aged 18 to 50 years, inclusive, at the time of signing the informed consent form.
- 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.
Who cannot join
- 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.
- History of acute or chronic pancreatitis, symptomatic gallbladder disease, pancreatic injury, or other high-risk factors that may lead to pancreatitis.
- History or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2; history of thyroid insufficiency or abnormal thyroid hormone levels.
- 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).
- 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.
- Hemorrhagic or ischemic stroke within 6 months prior to screening, if judged by the investigator to be unsuitable for participation in this clinical trial.
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- 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).
- Any laboratory finding at screening meeting any of the following criteria:
- glycated hemoglobin (HbA1c) ≥ 6.5%, or fasting blood glucose (GLU) > 6.1 mmol/L or < 3.9 mmol/L.
- alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin (TBIL) > 1.5 times the upper limit of normal (ULN).
- 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.
- serum uric acid (UA) > 540 μmol/L.
- serum calcitonin (PCT) ≥ 35 ng/L.
- thyroid-stimulating hormone (TSH) > 6.0 mIU/L or below the lower limit of normal (LLN).
- fasting triglycerides (TG) ≥ 3.42 mmol/L.
- amylase (AMY) > 1.5 times ULN.
- hemoglobin (HGB) < 100 g/L (female) or < 110 g/L (male).
- positive for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), or Treponema pallidum antibody (TPAb).
- 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.
- positive urine drug abuse screening.
- positive alcohol breath test.
- Participation in any drug or medical device clinical trial and receipt of investigational drug or medical device intervention within 3 months prior to screening.
- Use of any prescription or over-the-counter medication (including chemical drugs, vitamins, herbal medicines, etc.) within 2 weeks prior to dosing.
- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Yunnan University of Chinese Medicine (Yunnan Provincial Hospital of Traditional Chinese Medicine)
Kunming, Yunnan
About this study
Official title: A Randomized, Open-Label Study to Evaluate the Effects of Different Dosing Conditions and Post-Dose Meal Timing on the Pharmacokinetics of MWN109 Tablets in Chinese Adult Participants
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]).
- Being tested
- MWN109 Tablets
- Medical subject headings
- Diabetes Mellitus, Type 2, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MWN109 TabletsDrug
administered orally
| Study group | Role | What they receive |
|---|---|---|
| Part 1 | Experimental | Participants receive oral MWN109 tablets under varying conditions of administration water volume and post-dose feeding time. Receives: Drug: MWN109 Tablets |
| Part 2 | Experimental | Participants take oral MWN109 tablets under three conditions: fasted state, fed state, or feeding after drug administration. Receives: Drug: MWN109 Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Concentration (Cmax)
Cmax of MWN109.
Measured: From Day 1 to Day 29
Minimum Concentration (Cmin)
Cmin of MWN109.
Measured: From Day 1 to Day 29
Area Under the Curve From Time 0 to Last Quantifiable Time Point (AUC0-t)
AUC0-t of MWN109.
Measured: From Day 1 to Day 29
Area Under the Curve From Time 0 to Infinity (AUC0-inf)
AUC0-inf of MWN109.
Measured: From Day 1 to Day 29
Time to Reach Maximum Concentration (Tmax)
Tmax of MWN109.
Measured: From Day 1 to Day 29
Elimination Half-Life (t1/2)
t1/2 of MWN109.
Measured: From Day 1 to Day 29
Secondary outcomes (2)
Incidence of adverse events (AEs)
The incidence of adverse events (AEs) and serious adverse events (SAEs).
Measured: From Day 1 to Day 29
Anti-Drug Antibody (ADA)
ADA of MWN109.
Measured: From Day 1 to Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start24 May 2026
- Primary completion10 Aug 2026
- Study completion10 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Minwei Biotechnology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07801326
- Sponsor's protocol ID
- MWN109-Oral-I-EPK
- Status last verified
- Aug 2026
- First submitted
- 31 Aug 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label Study to Evaluate the Effects of Different Dosing Conditions and Post-Dose Meal Timing on the Pharmacokinetics of MWN109 Tablets in Chinese Adult Participants
- ClinicalTrials.gov ID
- NCT07801326
- Acronym / sponsor ID
- MWN109-Oral-I-EPK
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Shanghai Minwei Biotechnology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 24 May 2026 (actual)
- Primary completion
- 10 Aug 2026 (actual)
- Study completion
- 10 Aug 2026 (actual)
- First posted
- 3 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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]).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1 | Experimental | Drug: MWN109 TabletsParticipants receive oral MWN109 tablets under varying conditions of administration water volume and post-dose feeding time. |
| Part 2 | Experimental | Drug: MWN109 TabletsParticipants take oral MWN109 tablets under three conditions: fasted state, fed state, or feeding after drug administration. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Male or female participants aged 18 to 50 years, inclusive, at the time of signing the informed consent form.
- 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.
Key exclusion criteria (25 listed)
- 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.
- History of acute or chronic pancreatitis, symptomatic gallbladder disease, pancreatic injury, or other high-risk factors that may lead to pancreatitis.
- History or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2; history of thyroid insufficiency or abnormal thyroid hormone levels.
- 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).
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MWN109 Tabletsadministered orally | Drug | Part 1, Part 2 |
Primary outcome
Maximum Concentration (Cmax)
Time frame: From Day 1 to Day 29
Cmax of MWN109.
Minimum Concentration (Cmin)
Time frame: From Day 1 to Day 29
Cmin of MWN109.
Area Under the Curve From Time 0 to Last Quantifiable Time Point (AUC0-t)
Time frame: From Day 1 to Day 29
AUC0-t of MWN109.
Area Under the Curve From Time 0 to Infinity (AUC0-inf)
Time frame: From Day 1 to Day 29
AUC0-inf of MWN109.
Time to Reach Maximum Concentration (Tmax)
Time frame: From Day 1 to Day 29
Tmax of MWN109.
Elimination Half-Life (t1/2)
Time frame: From Day 1 to Day 29
t1/2 of MWN109.
2 secondary outcomes
Incidence of adverse events (AEs)
Time frame: From Day 1 to Day 29
Anti-Drug Antibody (ADA)
Time frame: From Day 1 to Day 29
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MWN109 Tablets in people with Type 2 Diabetes Mellitus (T2DM) and Overweight , Obesity, run by Shanghai Minwei Biotechnology Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Concentration (Cmax) (time frame: From Day 1 to Day 29). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.