Can meal timing boost a new oral Drug's potential?

NCT ID NCT07787611

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 26, 2026 · Last updated Aug 27, 2026 · Updated 1 time

Summary

This Phase 1 trial in healthy Chinese adults aims to assess the safety and tolerability of an experimental oral drug, MWN109, and how well the body absorbs it. Researchers will also explore whether taking the tablet with or without food changes its effects. The study involves single and multiple doses, with participants monitored for side effects and drug levels in the blood.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
MWN109 tablet
What this could lead to
If successful, this early trial could pave the way for larger studies of MWN109, potentially leading to a new oral medication for conditions like metabolic disorders.
What could go wrong
This is a small, early-phase safety study in healthy volunteers, so it cannot yet determine if MWN109 works for any disease. The drug may prove unsafe or ineffective in later trials.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

98 people

The number who actually took part.

Started

Jun 2025

Finished

Dec 2025

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 50 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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 50 years (inclusive at the time of signing the informed consent form). 2. Body mass index (BMI) = weight (kg) / height squared (m²): SAD part: 19.0 to 29.9 kg/m² (inclusive), with body weight ≥ 55 kg (male) or ≥ 50 kg (female); MAD part: 24.0 to 37.5 kg/m² (inclusive), with body weight ≥ 70 kg (male) or ≥ 60 kg (female). 3. Resting heart rate/pulse ≥ 55 beats/min and ≤ 90 beats/min at screening and before randomization. Exclusion Criteria: 1. History of severe drug allergy (especially known or suspected allergy to the excipients 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, or amylase or lipase \> 1.5 times the upper limit of normal (ULN) at screening. 3. Family history or history of medullary thyroid carcinoma; history of thyroid insufficiency or abnormal thyroid hormone levels. 4. Gastrointestinal diseases present at screening that may increase participant risk, such as abnormal gastric emptying (e.g., gastroparesis, pyloric stenosis, pyloric obstruction) or severe chronic gastrointestinal diseases (e.g., history of intestinal obstruction, active ulcer within 6 months). 5. History of infectious disease within 4 weeks prior to screening (which, in the investigator's judgment, may significantly affect the safety evaluation of the participant), or severe trauma or major surgery within 3 months. 6. History of severe arrhythmia prior to screening judged by the investigator as unsuitable for participation in this study. 7. Any of the following abnormal laboratory findings at screening: a) fasting blood glucose ≥ 7.0 mmol/L or \< 3.9 mmol/L, or HbA1c \> 6.5%; b) estimated glomerular filtration rate (eGFR) \< 90 mL/min/1.73 m²; c) triglycerides (TG) ≥ 5.65 mmol/L. 8. Blood donation, significant blood loss (\> 400 mL), or receipt of blood transfusion within 3 months prior to screening.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • The First Affiliated Hospital of Yunnan University of Chinese Medicine (Yunnan Provincial Hospital of Traditional Chinese Medicine)

    Kunming, Yunnan, China

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