Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

New diabetes pill put to the test: does food change how it works?

NCT ID NCT07511010

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase trial in 28 healthy Chinese adults tests a new fixed-dose combination pill for type 2 diabetes. One part checks whether a high-fat meal changes how much drug gets into the blood. The other part looks at drug levels after taking the pill daily for 10 days. The goal is to gather safety and dosing information, not to treat diabetes yet.

What this could mean

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

Active substance
Chiglitazar/Metformin extended-release tablets
What this could lead to
If successful, this study will show how to best take this new diabetes pill (with or without food) and confirm the right dosing schedule for future trials.
What could go wrong
This is a very early, small study in healthy people, not patients. It only measures drug levels and safety, not whether the drug actually controls diabetes. Results may not predict real-world effectiveness.

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

About 28 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Oct 2026

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 45 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: * Healthy male or female participants; * Age from 18 to 45 years, inclusive; * Body Mass Index (BMI) between 19.0 and 26.0 kg/m² (inclusive). Male participants must weigh at least 50.0 kg, and female participants must weigh at least 45.0 kg; * From the time of signing the informed consent form until 3 months after the last dose, participants must have no plans for pregnancy or sperm donation and must be willing to use effective contraceptive measures; * Voluntarily agrees to participate in the study and signs the informed consent form. Exclusion Criteria: * Any clinically significant abnormalities in laboratory tests or a history of clinically significant diseases, including but not limited to cardiovascular, cerebrovascular, hepatic, renal, respiratory, gastrointestinal, neurological, hematological, immune, oncological, psychiatric, or endocrine/metabolic disorders; * Known history of severe allergies (e.g., allergy to more than 3 allergens, allergies affecting the lower respiratory tract such as allergic asthma, allergies requiring glucocorticoid treatment) or a known history of allergy to any component of the investigational products; * Previous surgery that could affect drug absorption, distribution, metabolism, or excretion (e.g., subtotal gastrectomy), or a history of gastrointestinal, hepatic, or renal disease within the last 6 months that could affect drug absorption or metabolism; * Surgery within 3 months prior to screening or planned surgery during the study period; * Received any vaccination within 1 month prior to screening or plan to receive any vaccination during the study period; * History of infectious disease treated with significant use of antibiotics within 3 months before the first dose, or any infectious disease within 7 days before the first dose; * Presence of gastrointestinal symptoms (e.g., diarrhea, constipation, nausea, vomiting) within 7 days before the first dose, which the investigator deems unsuitable for study participation; * Use of any prescription drugs, over-the-counter drugs, or Chinese herbal medicines within 1 month before the first dose; or use of vitamin products within 2 weeks before enrollment; * History of drug or substance abuse, or a positive alcohol or urine drug screening test; * Intolerance to venipuncture, or a history of fainting in response to needles or blood; * Fasting blood glucose \> 6.1 mmol/L or \< 3.9 mmol/L at screening, and/or a history of hypoglycemia/syncope; * Participation in any interventional clinical trial within 3 months prior to screening; * Blood donation or significant blood loss (\> 200 mL) within 3 months prior to screening; * Pregnant or lactating women; * Weekly alcohol consumption of more than 14 units within 3 months prior to screening, consumption of alcohol within 48 hours before the first dose, or inability to abstain from alcohol during the study; * Smokes more than 5 cigarettes per day within 3 months prior to screening, has smoked within 48 hours before the first dose, or is unable to abstain from smoking during the study; * Excessive daily consumption of tea, coffee, and/or caffeinated beverages within 3 months prior to screening, or consumption of such beverages within 48 hours before the first dose; * Consumption of grapefruit or grapefruit-related citrus fruits (e.g., Seville oranges, pomelos), star fruit, papaya, pomegranate, or their products within 14 days before the first dose; * Glomerular Filtration Rate (GFR) \< 90 mL/min/1.73 m²; * Systolic blood pressure \< 90 mmHg or ≥ 140 mmHg, or diastolic blood pressure \< 50 mmHg or ≥ 90 mmHg at screening; * Inability to comply with the standardized diet (e.g., intolerance to the high-fat meal, lactose intolerance) or has difficulty swallowing; * Plans to or is required to engage in strenuous physical activity or exercise during the study period; * Any other condition that, in the opinion of the investigator, makes the participant unsuitable for inclusion in the study.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for T2DM (type 2 diabetes mellitus) are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

Other studies related to the condition(s) this trial covers.