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T2DM (Type 2 Diabetes Mellitus)Phase 1NCT07511010

Food Effect and Multiple-Dose Study of Chiglitazar/Metformin Extended-Release Tablets

A Phase 1 study testing Chiglitazar/Metformin extended-release tablets under fasting conditions, Chiglitazar/Metformin extended-release tablets after a high-fat meal and multiple-dose of Chiglitazar/Metformin extended-release tablets in people with T2DM (Type 2 Diabetes Mellitus), run by Chipscreen Biosciences, Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This trial includes two parts: a food effect (FE) study and a multiple-dose pharmacokinetic (PK) study. The FE study is a randomized, open-label, two-period, two-sequence crossover study designed to evaluate the effect of a high-fat meal on the PK of a single oral dose of Chiglitazar/Metformin extended-release tablets… Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
T2DM (Type 2 Diabetes Mellitus)
What is being tested?
Chiglitazar/Metformin extended-release tablets under fasting conditions, Chiglitazar/Metformin extended-release tablets after a high-fat meal and multiple-dose of Chiglitazar/Metformin extended-release tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteChina
Study dates
10 Sep 2026to 25 Oct 2026
Phase
Phase 1
Are there results?
None posted in the registry

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 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Ditan Hospital, Capital Medical University

    Beijing, Beijing Municipality, 101300

Other trials in China

About this study

Official title: A Phase I Clinical Study to Assess the Food Effect and Multiple Dose Pharmacokinetic of Chiglitazar/Metformin Extended-Release Fixed Dose Combination Tablets

This trial includes two parts: a food effect (FE) study and a multiple-dose pharmacokinetic (PK) study.

The FE study is a randomized, open-label, two-period, two-sequence crossover study designed to evaluate the effect of a high-fat meal on the PK of a single oral dose of Chiglitazar/Metformin extended-release tablets in healthy adult Chinese participants.

The multiple-dose PK study is an open-label study designed to evaluate the PK characteristics of Chiglitazar/Metformin extended-release tablets in healthy adult Chinese participants following multiple oral doses.

Being tested
Chiglitazar/Metformin extended-release tablets under fasting conditions, Chiglitazar/Metformin extended-release tablets after a high-fat meal, multiple-dose of Chiglitazar/Metformin extended-release tablets
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.

  • Chiglitazar/Metformin extended-release tablets under fasting conditionsDrug

    a single dose of Chiglitazar/Metformin extended-release tablets under fasting conditions

  • Chiglitazar/Metformin extended-release tablets after a high-fat mealDrug

    a single dose of Chiglitazar/Metformin extended-release tablets after a high-fat meal

  • multiple-dose of Chiglitazar/Metformin extended-release tabletsDrug

    a single dose on Day 1, once-daily consecutive doses from Day 4 to Day 10

Study groups in NCT07511010
Study groupRoleWhat they receive
Sequence 1 of FE studyExperimentalNot described
Receives: Drug: Chiglitazar/Metformin extended-release tablets under fasting conditions; Drug: Chiglitazar/Metformin extended-release tablets after a high-fat meal
Sequence 2 of FE studyExperimentalNot described
Receives: Drug: Chiglitazar/Metformin extended-release tablets under fasting conditions; Drug: Chiglitazar/Metformin extended-release tablets after a high-fat meal
multiple-dose groupExperimentalNot described
Receives: Drug: multiple-dose of Chiglitazar/Metformin extended-release tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. FE Study: Maximum plasma concentration (Cmax)

    Measured: Pre-dose and at multiple timepoints post-dose up to 72 hours

  2. FE Study: Area Under the Plasma Concentration-Time Curve (AUC)

    Measured: Pre-dose and at multiple timepoints post-dose up to 72 hours

  3. FE Study: Time to Maximum Plasma Concentration（Tmax）

    Measured: Pre-dose and at multiple timepoints post-dose up to 72 hours

  4. FE Study: Elimination Half-life （t1/2）

    Measured: Pre-dose and at multiple timepoints post-dose up to 72 hours

  5. FE Study: Apparent Total Clearance （CL/F）

    Measured: Pre-dose and at multiple timepoints post-dose up to 72 hours

  6. FE Study: Apparent Volume of Distribution during the terminal phase （Vz/F）

    Measured: Pre-dose and at multiple timepoints post-dose up to 72 hours

  7. Multiple-dose PK study: Maximum plasma concentration (Cmax)

    Measured: predose to 72 hours after the last dose (7 consecutive days of dosing)

  8. Multiple-dose PK Study: Area Under the Plasma Concentration-Time Curve (AUC)

    Measured: predose to 72 hours after the last dose (7 consecutive days of dosing)

  9. Multiple-dose PK Study: Time to Maximum Plasma Concentration（Tmax）

    Measured: predose to 72 hours after the last dose (7 consecutive days of dosing)

  10. Multiple-dose PK Study: steady-state peak concentration (Cmax,ss)

    Measured: predose to 72 hours after the last dose (7 consecutive days of dosing)

  11. Multiple-dose PK Study: steady-state time to peak concentration (Tmax,ss)

    Measured: predose to 72 hours after the last dose (7 consecutive days of dosing)

  12. Multiple-dose PK Study: under the plasma concentration-time curve at steady state (AUCss)

    Measured: predose to 72 hours after the last dose (7 consecutive days of dosing)

  13. Multiple-dose PK Study: trough concentration (Ctrough)

    Measured: predose to 72 hours after the last dose (7 consecutive days of dosing)

  14. Multiple-dose PK Study: accumulation ratio (Rac)

    Measured: predose to 72 hours after the last dose (7 consecutive days of dosing)

Secondary outcomes (4)

  1. Incidence of Adverse Events (AEs)

    Measured: up to Day 16

  2. Change from baseline in hematology parameters: white blood cell count, neutrophil count, lymphocyte count, monocyte count, eosinophil count, basophil count, red blood cell count , hemoglobin, hematocrit, platelet count

    Change from baseline in hematology parameters: white blood cell count (WBC), neutrophil count, lymphocyte count, monocyte count, eosinophil count, basophil count, red blood cell count (RBC), hemoglobin (Hb), hematocrit (HCT), platelet count (PLT)

    Measured: up to Day 13

  3. Changes from baseline in serum chemistry parameters

    Changes from baseline in serum chemistry parameters: fasting blood glucose (FBG), total protein, albumin, total bilirubin, direct bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total cholesterol, triglycerides, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), blood urea nitrogen (BUN) or urea, uric acid, creatinine, potassium (K⁺), sodium (Na⁺), chloride (Cl-), creatine kinase (CK)

    Measured: up to Day 13

  4. Changes from baseline in urinalysis parameters: urine protein, urine ketones, urine glucose, urine pH, urine leukocytes, urine red blood cells

    Changes from baseline in urinalysis parameters: urine protein, urine ketones, urine glucose, urine pH, urine leukocytes, urine red blood cells (RBCs)

    Measured: up to Day 13

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2026
  2. Study start10 Sep 2026
  3. Primary completion22 Oct 2026
  4. Study completion25 Oct 2026

Resources

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 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07511010
Sponsor's protocol ID
CGZ111
Status last verified
Nov 2026
First submitted
20 Mar 2026
Last updated
5 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Chiglitazar/Metformin extended-release tablets under fasting conditions, Chiglitazar/Metformin extended-release tablets after a high-fat meal and multiple-dose of Chiglitazar/Metformin extended-release tablets in people with T2DM (Type 2 Diabetes Mellitus), run by Chipscreen Biosciences, 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 5 inclusion and 23 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: finished, as of the sponsor's last update on 5 Nov 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

FE Study: Maximum plasma concentration (Cmax) (time frame: Pre-dose and at multiple timepoints post-dose up to 72 hours). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07511010.

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 5 Nov 2026.

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