Can a new daily pill outperform semaglutide for diabetes?

NCT ID NCT07801820

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 03, 2026 · Last updated Sep 09, 2026 · Updated 2 times

Summary

Researchers are testing an experimental oral drug called MWN109 in adults with type 2 diabetes. The trial compares several doses of MWN109 against a placebo and against semaglutide tablets, a standard treatment, to see which works better at lowering blood sugar over 20 weeks. About 240 participants aged 18 to 75 will take the assigned pill once daily. The study also tracks weight changes, safety, and how the body processes the drug.

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 experimental oral drug for type 2 diabetes
What this could lead to
If MWN109 works, it could offer a new once-daily pill to help people with type 2 diabetes control blood sugar and possibly lose weight.
What could go wrong
This is an early Phase II trial with 240 participants, so the drug may not prove more effective than existing treatments or may cause unexpected side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 240 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show 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 75 years (inclusive) at the time of signing the informed consent form. 2. 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. 3. HbA1c ≥7.5% and ≤11.0% at screening and before randomization (central laboratory). 4. 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). 5. BMI ≥20.0 kg/m² and ≤40.0 kg/m² at screening. 6. Self-reported body weight change of \<5% during the at least 12 weeks prior to screening. Exclusion Criteria: 1. 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. 2. Diagnosed or suspected type 1 diabetes mellitus, other specific types of diabetes mellitus (excluding gestational diabetes mellitus), or secondary diabetes mellitus. 3. 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). 4. Use of insulin within 1 year prior to randomization (except for acute short-term use of ≤14 days). 5. Diabetic ketoacidosis or hyperosmolar hyperglycemic state within 24 weeks prior to randomization. 6. 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. 7. 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). 8. 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. 9. Any unstable or untreated endocrine disease other than type 2 diabetes mellitus (e.g., multiple endocrine neoplasia, acromegaly, Cushing's syndrome). 10. 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). 11. Medullary thyroid carcinoma, multiple endocrine neoplasia type 2 (MEN2), or a personal or first-degree family history of these conditions. 12. Significant active autoimmune abnormalities (e.g., systemic lupus erythematosus, rheumatoid arthritis) requiring systemic glucocorticoids. 13. Major cardiovascular or cerebrovascular diseases within 24 weeks prior to screening or before randomization (e.g., myocardial infarction, cerebrovascular accident, unstable angina). 14. Known or pre-randomization ECG abnormalities with significant safety risk (e.g., QTcF \>450 ms). 15. History of sporadic or frequent premature beats or tachycardia, or heart rate \>100 beats/min before randomization. 16. Uncontrolled hypertension at screening or before randomization (≥160/100 mmHg) or untreated hypertension meeting this criterion. 17. 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).

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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.

How to take part

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  1. The places running it

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  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  3. A doctor treating you

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Contacts and locations

Locations

  • Peking University People's Hospital

    RECRUITING

    Beijing, Beijing Municipality, China

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