Could a single pill replace two for diabetes?
NCT ID NCT07412015
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This pilot study will test whether a new fixed-dose combination tablet containing Chiglitazar and Metformin works the same in the body as taking the two drugs separately. Twenty-four healthy adults will receive both versions under fed conditions, and researchers will measure drug levels in the blood. The goal is to see if the combo pill is a viable option for simplifying type 2 diabetes treatment.
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 fixed dose combination tablets
- What this could lead to
- If successful, this could lead to a simpler once-daily pill for type 2 diabetes, making treatment easier for patients.
- What could go wrong
- This is a very early pilot study in only 24 healthy people, not patients. It only checks how the drug is processed in the body, not whether it works for diabetes. Results may not predict real-world benefits.
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
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 45 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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 \< 60 mmHg or ≥ 90 mmHg at screening; * A positive test result at screening for any of the following: Human Immunodeficiency Virus antibody, Treponema pallidum antibody, Hepatitis B surface antigen, or Hepatitis C virus antibody; * 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.
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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
Only the study team decides who joins. These are the ways to reach them.
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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.
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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.
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Other studies related to the condition(s) this trial covers.
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