T2DMPhase 1NCT05681273

Drug-Drug Interaction Study of Chiglitazar in Healthy Subjects.

A Phase 1 study testing Chiglitazar, Empagliflozin and Atorvastatin in people with T2DM, 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 Phase 1 open label study is being conducted to characterize the pharmacokinetic (PK) and safety profiles of Chiglitazar with Empagliflozin，Atorvastatin and Valsartan in healthy subjects. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: T2DM
What is being tested?: Chiglitazar, Empagliflozin and Atorvastatin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: 1 siteChina
Study dates: 17 Feb 2023to 21 Mar 2023
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 and female subjects between the ages of 18 and 45 years, inclusive;
19.0≤BMI≤26.0 kg/m2. Weight of male ≥50 kg and Weight of female ≥ 45 kg.

Who cannot join

History of clinically significant allergy or atopic allergic disease, or allergy to the study drug;
Previous surgery may affect drug absorption, distribution, metabolism and excretion; or have suffered from gastrointestinal, liver and kidney diseases that can affect drug absorption or metabolism in the past 6 months;
History of tuberculosis;
Frequent infection history in the past year, or serious infections leading to hospitalization within 3 months before administration;
untreated diarrhea, or diarrhea within 7 days before administration;
Any drugs, vitamin products or herbal medicine used within 1 month before administration;

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History of drug abuse;
Participated in clinical trial within 3 months before administration;
Blood donation or massive blood loss within 3 months before the first administration;
Pregnant or lactating women;
Regular drinking history; or took any alcoholic products within 48 hours before administration; or positive alcohol test;
Regular smoking history within 3 months before administration or cannot quit smoking during the trial;
GFR<80 mL/min;
Abnormal results of laboratory examination,vital signs, 12 lead ECG, physical examination and chest X-ray;
Systolic blood pressure<90 or ≥ 140 mmHg, diastolic blood pressure<60 or ≥ 90 mmHg;
Other situations that are not suitable for participate the study.

Trial locations and contacts

1 site in 1 country.

China1 site

Zhongshan hospital
Shanghai

Other trials in China

About this study

Official title: A Phase I Study to Evaluate the Drug-Drug Interaction of Chiglitazar With Empagliflozin，Atorvastatin and Valsartan in Healthy Subjects.

This Phase 1 open label study is being conducted to characterize the pharmacokinetic (PK) and safety profiles of Chiglitazar with Empagliflozin，Atorvastatin and Valsartan in healthy subjects.

Conditions: T2DM
Being tested: Chiglitazar, Empagliflozin, Atorvastatin, Valsartan

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ChiglitazarDrug
Chiglitazar 48mg
EmpagliflozinDrug
Empagliflozin 10mg
AtorvastatinDrug
Atorvastatin 20mg
ValsartanDrug
Valsartan 160mg

Study groups in NCT05681273
Study group	Role	What they receive
Group A	Experimental	D1: Oral single dose of Empagliflozin 10 mg; D5~9: Oral multiple doses of Chiglitazar 48 mg; D10: Oral single dose of Empagliflozin 10 mg and Chiglitazar 48 mg. Receives: Drug: Chiglitazar; Drug: Empagliflozin
Group B	Experimental	D1: Oral single dose of Atorvastatin 20 mg; D5~9: Oral multiple doses of Chiglitazar 48 mg; D10: Oral single dose of Atorvastatin 20 mg and Chiglitazar 48 mg. Receives: Drug: Chiglitazar; Drug: Atorvastatin
Group C	Experimental	D1: Oral single dose of Valsartan 160 mg; D5~9: Oral multiple doses of Chiglitazar 48 mg; D10: Oral single dose of Valsartan 160 mg and Chiglitazar 48 mg. Receives: Drug: Chiglitazar; Drug: Valsartan

What is being measured

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

Cmax
Maximum plasma concentration
Measured: up to 72 hours
AUC0-t and AUC0-inf
Area under of the curve (AUC0-t and AUC0-inf)
Measured: up to 72 hours

Timeline

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

17 Feb 202321 Mar 2023

First posted12 Jan 2023
Study start17 Feb 2023
Primary completion21 Mar 2023
Study completion21 Mar 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for T2DMStudies of the same condition, open and under way.
More trials run by Chipscreen Biosciences, Ltd.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05681273
Sponsor's protocol ID: CGZ110
Status last verified: Dec 2022
First submitted: 27 Dec 2022
Last updated: 15 Jun 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Sheng L, Li X, Yu J, Yang X, Li H, Xu H. Drug-Drug Interaction of Chiglitazar with Empagliflozin, Atorvastatin, and Valsartan: An Open-Label, Single-Center, Self-Control, 3-Period Study. Drug Des Devel Ther. 2026 May 8;20:588573. doi: 10.2147/DDDT.S588573. eCollection 2026.
PubMed 42148367

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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A Study to Evaluate the Effects of Enicepatide in Participants With Obesity or Overweight, With or Without Type 2 Diabetes
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An Observational Study to Learn More About How Safe Finerenone is and How Well it Works in Indian People With Chronic Kidney Disease and Type 2 Diabetes in Routine Medical Practice
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All T2DM trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I Study to Evaluate the Drug-Drug Interaction of Chiglitazar With Empagliflozin，Atorvastatin and Valsartan in Healthy Subjects.
ClinicalTrials.gov ID: NCT05681273
Acronym / sponsor ID: CGZ110
Conditions: T2DM
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: Chipscreen Biosciences, Ltd.Industry (pharma, biotech, devices)
Study start: 17 Feb 2023 (actual)
Primary completion: 21 Mar 2023 (actual)
Study completion: 21 Mar 2023 (actual)
First posted: 12 Jan 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This Phase 1 open label study is being conducted to characterize the pharmacokinetic (PK) and safety profiles of Chiglitazar with Empagliflozin，Atorvastatin and Valsartan in healthy subjects.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Group A	Experimental	Drug: Chiglitazar, Drug: EmpagliflozinD1: Oral single dose of Empagliflozin 10 mg; D5~9: Oral multiple doses of Chiglitazar 48 mg; D10: Oral single dose of Empagliflozin 10 mg and Chiglitazar 48 mg.
Group B	Experimental	Drug: Chiglitazar, Drug: AtorvastatinD1: Oral single dose of Atorvastatin 20 mg; D5~9: Oral multiple doses of Chiglitazar 48 mg; D10: Oral single dose of Atorvastatin 20 mg and Chiglitazar 48 mg.
Group C	Experimental	Drug: Chiglitazar, Drug: ValsartanD1: Oral single dose of Valsartan 160 mg; D5~9: Oral multiple doses of Chiglitazar 48 mg; D10: Oral single dose of Valsartan 160 mg and Chiglitazar 48 mg.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Healthy male and female subjects between the ages of 18 and 45 years, inclusive;
19.0≤BMI≤26.0 kg/m2. Weight of male ≥50 kg and Weight of female ≥ 45 kg.

Key exclusion criteria (16 listed)

History of clinically significant allergy or atopic allergic disease, or allergy to the study drug;
Previous surgery may affect drug absorption, distribution, metabolism and excretion; or have suffered from gastrointestinal, liver and kidney diseases that can affect drug absorption or metabolism in the past 6 months;
History of tuberculosis;
Frequent infection history in the past year, or serious infections leading to hospitalization within 3 months before administration;
untreated diarrhea, or diarrhea within 7 days before administration;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ChiglitazarChiglitazar 48mg	Drug	Group A, Group B, Group C
EmpagliflozinEmpagliflozin 10mg	Drug	Group A
AtorvastatinAtorvastatin 20mg	Drug	Group B
ValsartanValsartan 160mg	Drug	Group C

Primary outcome

Cmax
Time frame: up to 72 hours
Maximum plasma concentration
AUC0-t and AUC0-inf
Time frame: up to 72 hours
Area under of the curve (AUC0-t and AUC0-inf)

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
Derived from this study: PubMed 42148367Sheng L, Li X, Yu J, Yang X, Li H, Xu H. Drug-Drug Interaction of Chiglitazar with Empagliflozin, Atorvastatin, and Valsartan: An Open-Label, Single-Center, Self-Control, 3-Period Study. Drug Des Devel Ther. 2026 May 8;20:588573. doi: 10.2147/DDDT.S588573. eCollection 2026.

Related trials for T2DM

Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 2
A Phase 2 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of SAL0150 Tablets in Subjects With Type 2 Diabetes Mellitus
Type 2 Diabetes Mellitus (T2DM), Type 2 Diabetes
RecruitingPhase 3
A Study to Evaluate the Effects of Enicepatide in Participants With Obesity or Overweight, With or Without Type 2 Diabetes
Obesity, Overweight
RecruitingObservational study
Chiglitazar Added to SGLT-2 Inhibitors for Type 2 Diabetes
T2DM (Type 2 Diabetes Mellitus)
Active, not recruitingObservational study
An Observational Study to Learn More About How Safe Finerenone is and How Well it Works in Indian People With Chronic Kidney Disease and Type 2 Diabetes in Routine Medical Practice
Chronic Kidney Disease, Type 2 Diabetes Mellitus

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Hongrong Xu principal investigator

Shanghai Zhongshan Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Chiglitazar, Empagliflozin and Atorvastatin in people with T2DM, 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 2 inclusion and 16 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 15 Jun 2023. 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?

Cmax (time frame: up to 72 hours). The study lists 2 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 NCT05681273, which also lists 1 linked publication.

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 15 Jun 2023.