Type 2 Diabetes Mellitus (T2DM)Phase 2NCT07801820
Phase 2 Clinical Study of MWN109 Tablets in Participants With Type 2 Diabetes Mellitus
A Phase 2 study testing MWN109 1, MWN109 2 and MWN109 3 in people with Type 2 Diabetes Mellitus (T2DM), run by Shanghai Minwei Biotechnology Co., Ltd at 1 site in China.
Trial summary
This is a randomized, double-blind, placebo- and active-controlled, multicenter Phase II clinical trial designed to evaluate the efficacy, safety, and pharmacokinetic characteristics of MWN109 tablets in participants with type 2 diabetes mellitus (T2DM). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM)
- What is being tested?
- MWN109 1, MWN109 2 and MWN109 3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 23 Jun 2026to Mar 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female participants aged 18 to 75 years (inclusive) at the time of signing the informed consent form.
- Diagnosis of type 2 diabetes mellitus for at least 3 months prior to screening, with inadequate glycemic control despite treatment with lifestyle intervention or a stable dose of metformin monotherapy (≥1500 mg/day, or ≥1000 mg/day if at the maximum tolerated dose) for at least 3 months prior to screening.
- HbA1c ≥7.5% and ≤11.0% at screening and before randomization (central laboratory).
- Fasting plasma glucose ≤13.9 mmol/L at screening and before randomization (central laboratory; may be re-tested once within 1 week if special circumstances apply).
- BMI ≥20.0 kg/m² and ≤40.0 kg/m² at screening.
- Self-reported body weight change of <5% during the at least 12 weeks prior to screening.
Who cannot join
- Known allergic constitution (allergy to 3 or more foods or drugs), allergy to GLP-1 receptor agonists or any component of the study drug, severe allergic disease, or a history of severe drug allergy.
- Diagnosed or suspected type 1 diabetes mellitus, other specific types of diabetes mellitus (excluding gestational diabetes mellitus), or secondary diabetes mellitus.
- Severe chronic complications of diabetes mellitus (e.g., diabetic nephropathy, proliferative diabetic retinopathy, non-proliferative diabetic retinopathy requiring treatment, peripheral vascular disease with amputation, chronic foot ulcer, intermittent claudication, or painful diabetic neuropathy).
- Use of insulin within 1 year prior to randomization (except for acute short-term use of ≤14 days).
- Diabetic ketoacidosis or hyperosmolar hyperglycemic state within 24 weeks prior to randomization.
- Grade 3 hypoglycemia within 12 months prior to randomization, or ≥3 episodes of Grade 2 hypoglycemia or hypoglycemia-related symptoms within 3 months prior to screening.
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- Trauma, infection, or surgery within 12 weeks prior to randomization that significantly affects glycemic control, or planned surgery during the study period (excluding outpatient procedures).
- Blood transfusion or blood donation/blood loss ≥400 mL within 12 weeks prior to randomization, or ≥200 mL within 4 weeks prior to screening, or hematologic diseases that may affect HbA1c or pose a safety risk.
- Any unstable or untreated endocrine disease other than type 2 diabetes mellitus (e.g., multiple endocrine neoplasia, acromegaly, Cushing's syndrome).
- History of thyroid disease (except under specific circumstances) or abnormal TSH (TSH >6.0 or <0.4 mIU/L in participants without a history of thyroid disease).
- Medullary thyroid carcinoma, multiple endocrine neoplasia type 2 (MEN2), or a personal or first-degree family history of these conditions.
- Significant active autoimmune abnormalities (e.g., systemic lupus erythematosus, rheumatoid arthritis) requiring systemic glucocorticoids.
- Major cardiovascular or cerebrovascular diseases within 24 weeks prior to screening or before randomization (e.g., myocardial infarction, cerebrovascular accident, unstable angina).
- Known or pre-randomization ECG abnormalities with significant safety risk (e.g., QTcF >450 ms).
- History of sporadic or frequent premature beats or tachycardia, or heart rate >100 beats/min before randomization.
- Uncontrolled hypertension at screening or before randomization (≥160/100 mmHg) or untreated hypertension meeting this criterion.
- Clinically significant abnormal laboratory findings at screening or before randomization (e.g., ALT or AST ≥3×ULN, eGFR <60 mL/min/1.73 m², anemia, calcitonin ≥35 ng/L).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality
Linong Ji, Doctor, +86 10 88324100, jiln@bjmu.edu.cn
About this study
Official title: A Randomized, Double-Blind, Placebo- and Active-Controlled, Multicenter Phase II Clinical Trial to Evaluate the Efficacy, Safety, and Pharmacokinetic Characteristics of MWN109 Tablets in Participants With Type 2 Diabetes Mellitus
This is a randomized, double-blind, placebo- and active-controlled, multicenter Phase II clinical trial designed to evaluate the efficacy, safety, and pharmacokinetic characteristics of MWN109 tablets in participants with type 2 diabetes mellitus (T2DM).
Eligible participants will be randomized to receive different dose levels of MWN109 tablets, MWN109-matched placebo, or semaglutide tablets 14 mg (active control), administered once daily for 20 consecutive weeks.
Approximately 240 adults aged 18 to 75 years with type 2 diabetes mellitus will be enrolled. The primary endpoint is the percent change from baseline in HbA1c at Week 20. Secondary endpoints include glycemic parameters, body weight, metabolic parameters, adverse events, and immunogenicity.
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Being tested
- MWN109 1, MWN109 2, MWN109 3, MWN109 4, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MWN109 1Drug
Administered orally, QD, 20 weeks
MWN109 2Drug
Administered orally, QD, 20 weeks
MWN109 3Drug
Administered orally, QD, 20 weeks
MWN109 4Drug
Administered orally, QD, 20 weeks
PlaceboDrug
Administered orally, QD, 20 weeks
Semaglutide TabletsDrug
Administered orally, QD, 20 weeks
| Study group | Role | What they receive |
|---|---|---|
| MWN109 Cohort 1 | Experimental | Not described Receives: Drug: MWN109 1 |
| MWN109 Cohort 2 | Experimental | Not described Receives: Drug: MWN109 2 |
| MWN109 Cohort 3 | Experimental | Not described Receives: Drug: MWN109 3 |
| MWN109 Cohort 4 | Experimental | Not described Receives: Drug: MWN109 4 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Semaglutide Tablets | Active comparator | Not described Receives: Drug: Semaglutide Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Glycated Hemoglobin (HbA1c) from Baseline at Week 20 Compared to Placebo
HbA1c is the glycated fraction of hemoglobin A. HbA1c is measured to identify the average plasma glucose concentration over prolonged periods.
Measured: Baseline, Week 20
Secondary outcomes (8)
Change in HbA1c from Baseline at Week 20 Compared with Semaglutide Tablets
Measured: Baseline, Week 20
Change from baseline in HbA1c
Measured: Baseline, Week 4, Week 8, Week 12, Week 16
Percentage of Participants With an HbA1c target value of < 7.0%
Measured: Week 4, Week 8, Week 12, Week 16
Percentage of Participants With an HbA1c target value of ≤ 6.5%
Measured: Week 4, Week 8, Week 12, Week 16
Percentage of Participants With an HbA1c target value of ≤ 5.7%
Measured: Week 4, Week 8, Week 12, Week 16]
Percentage of Participants With an HbA1c target value of <7.0% Without Confirmed Symptomatic Hypoglycemia
Measured: Week 20
Percentage of Participants With an HbA1c target value of ≤6.5% Without Confirmed Symptomatic Hypoglycemia
Measured: Week 20
Percentage of Participants With an HbA1c target value of ≤6.5% and ≥10% Body Weight Reduction
Measured: Week 20
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 start23 Jun 2026
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
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.
- More trials run by Shanghai Minwei Biotechnology Co., LtdThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 240 participants (estimated)
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
- NCT07801820
- Sponsor's protocol ID
- MWN109-Oral-T2DM-II
- Status last verified
- Aug 2026
- First submitted
- 31 Aug 2026
- Last updated
- 9 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 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo- and Active-Controlled, Multicenter Phase II Clinical Trial to Evaluate the Efficacy, Safety, and Pharmacokinetic Characteristics of MWN109 Tablets in Participants With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT07801820
- Acronym / sponsor ID
- MWN109-Oral-T2DM-II
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Shanghai Minwei Biotechnology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 23 Jun 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- 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, double-blind, placebo- and active-controlled, multicenter Phase II clinical trial designed to evaluate the efficacy, safety, and pharmacokinetic characteristics of MWN109 tablets in participants with type 2 diabetes mellitus (T2DM).
Eligible participants will be randomized to receive different dose levels of MWN109 tablets, MWN109-matched placebo, or semaglutide tablets 14 mg (active control), administered once daily for 20 consecutive weeks.
Approximately 240 adults aged 18 to 75 years with type 2 diabetes mellitus will be enrolled. The primary endpoint is the percent change from baseline in HbA1c at Week 20. Secondary endpoints include glycemic parameters, body weight, metabolic parameters, adverse events, and immunogenicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| MWN109 Cohort 1 | Experimental | Drug: MWN109 1 |
| MWN109 Cohort 2 | Experimental | Drug: MWN109 2 |
| MWN109 Cohort 3 | Experimental | Drug: MWN109 3 |
| MWN109 Cohort 4 | Experimental | Drug: MWN109 4 |
| Placebo | Placebo comparator | Drug: Placebo |
| Semaglutide Tablets | Active comparator | Drug: Semaglutide Tablets |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female participants aged 18 to 75 years (inclusive) at the time of signing the informed consent form.
- Diagnosis of type 2 diabetes mellitus for at least 3 months prior to screening, with inadequate glycemic control despite treatment with lifestyle intervention or a stable dose of metformin monotherapy (≥1500 mg/day, or ≥1000 mg/day if at the maximum tolerated dose) for at least 3 months prior to screening.
- HbA1c ≥7.5% and ≤11.0% at screening and before randomization (central laboratory).
- Fasting plasma glucose ≤13.9 mmol/L at screening and before randomization (central laboratory; may be re-tested once within 1 week if special circumstances apply).
- BMI ≥20.0 kg/m² and ≤40.0 kg/m² at screening.
Key exclusion criteria (17 listed)
- Known allergic constitution (allergy to 3 or more foods or drugs), allergy to GLP-1 receptor agonists or any component of the study drug, severe allergic disease, or a history of severe drug allergy.
- Diagnosed or suspected type 1 diabetes mellitus, other specific types of diabetes mellitus (excluding gestational diabetes mellitus), or secondary diabetes mellitus.
- Severe chronic complications of diabetes mellitus (e.g., diabetic nephropathy, proliferative diabetic retinopathy, non-proliferative diabetic retinopathy requiring treatment, peripheral vascular disease with amputation, chronic foot ulcer, intermittent claudication, or painful diabetic neuropathy).
- Use of insulin within 1 year prior to randomization (except for acute short-term use of ≤14 days).
- Diabetic ketoacidosis or hyperosmolar hyperglycemic state within 24 weeks prior to randomization.
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 1Administered orally, QD, 20 weeks | Drug | MWN109 Cohort 1 |
| MWN109 2Administered orally, QD, 20 weeks | Drug | MWN109 Cohort 2 |
| MWN109 3Administered orally, QD, 20 weeks | Drug | MWN109 Cohort 3 |
| MWN109 4Administered orally, QD, 20 weeks | Drug | MWN109 Cohort 4 |
| PlaceboAdministered orally, QD, 20 weeks | Drug | Placebo |
| Semaglutide TabletsAdministered orally, QD, 20 weeks | Drug | Semaglutide Tablets |
Primary outcome
Change in Glycated Hemoglobin (HbA1c) from Baseline at Week 20 Compared to Placebo
Time frame: Baseline, Week 20
HbA1c is the glycated fraction of hemoglobin A. HbA1c is measured to identify the average plasma glucose concentration over prolonged periods.
8 secondary outcomes
Change in HbA1c from Baseline at Week 20 Compared with Semaglutide Tablets
Time frame: Baseline, Week 20
Change from baseline in HbA1c
Time frame: Baseline, Week 4, Week 8, Week 12, Week 16
Percentage of Participants With an HbA1c target value of < 7.0%
Time frame: Week 4, Week 8, Week 12, Week 16
Percentage of Participants With an HbA1c target value of ≤ 6.5%
Time frame: Week 4, Week 8, Week 12, Week 16
Percentage of Participants With an HbA1c target value of ≤ 5.7%
Time frame: Week 4, Week 8, Week 12, Week 16]
Percentage of Participants With an HbA1c target value of <7.0% Without Confirmed Symptomatic Hypoglycemia
Time frame: Week 20
Percentage of Participants With an HbA1c target value of ≤6.5% Without Confirmed Symptomatic Hypoglycemia
Time frame: Week 20
Percentage of Participants With an HbA1c target value of ≤6.5% and ≥10% Body Weight Reduction
Time frame: Week 20
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MWN109 1, MWN109 2 and MWN109 3 in people with Type 2 Diabetes Mellitus (T2DM), 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 6 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 9 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wanxiang Chen (+86 13359015677, chenwanxiang@minweibiotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Glycated Hemoglobin (HbA1c) from Baseline at Week 20 Compared to Placebo (time frame: Baseline, Week 20). 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 9 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.