Type 2 DiabetesPhase 1/2NCT07065032
A Study of ZT002 Injection in Adult Chinese Subjects With Type 2 Diabetes Mellitus (T2DM)
A Phase 1/2 study testing ZT002 Injection in people with Type 2 Diabetes, run by Beijing QL Biopharmaceutical Co.,Ltd at 1 site in China.
Trial summary
This study will comprise a randomized, double blind, placebo controlled, multiple ascending dose, safety, tolerability and pharmacokinetic study of ZT002 in subjects with type 2 diabetes mellitus (T2DM). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- ZT002 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteChina
- Study dates
- 19 Feb 2024to 5 Aug 2024
- Phase
- Phase 1/2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females aged 18 to 65 years (inclusive, based on age at the time of signing the informed consent form);
- Body mass index (BMI) at screening ranges from 22-35 kg/m² (inclusive); BMI = Weight(kg)/ Height (m²).
- Type 2 diabetes mellitus has been diagnosed for ≥12 weeks according to the diagnostic and classification criteria for diabetes mellitus issued by the World Health Organization (WHO) in 1999 and the WHO Recommendations for Diagnosis Using Glycosylated Hemoglobin (HbA1c) (2011) supplemental diagnostic criteria; and one of the following conditions is met:
- Controlled by diet and exercise for 12 weeks prior to screening, with no prior use of any hypoglycemic drugs
- Use of only one oral hypoglycemic agent (including metformin, α-glucosidase inhibitors, dipeptidyl peptidase-4 [DPP-4] inhibitors, and sodium-glucose cotransporter 2 [SGLT2] inhibitors) in the 12 weeks prior to screening, but no further use in the 14 days prior to screening;
- At screening and before randomization: 7.0% ≤ glycosylated hemoglobin (HbA1c) ≤ 10.5% (hospital laboratory);
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- At screening and before randomization: fasting venous blood glucose ≤ 13.9 mmol/L (hospital laboratory);
- Exclusion criteria (Subjects meeting any of the following criteria will not be enrolled in the trial):
- History of specific allergies (asthma, eczema, etc.) or allergic constitution, or history of allergy to two or more drugs and foods, especially to the investigational drug and its excipients or GLP-1-containing drugs;
- Confirmed or suspected diagnosis of type 1 diabetes mellitus or specific types of diabetes mellitus (monogenic diabetes syndrome, cystic fibrosis, pancreatitis, drug or chemically induced diabetes mellitus, etc.) for other causes prior to screening;
- History of acute and chronic pancreatitis, history of symptomatic gallbladder disease (except for cholecystectomy), history of pancreatic injury, and other high risk factors for pancreatitis prior to screening;
- Previous personal or family history of medullary thyroid carcinoma (MTC) or type 2 multiple endocrine neoplasia syndrome (MEN2); or hyperthyroidism or hypothyroidism on stable dose medication for less than 3 months;
- Diabetic ketoacidosis (DKA) and hyperosmolar hyperglycemic syndrome (HHS), diabetic lactic acidosis, or hyperosmolar nonketotic diabetic coma within 12 months prior to screening;
- Proliferative retinopathy, maculopathy, symptomatic diabetic neuropathy, intermittent claudication, and diabetic foot that are unstable or require treatment within 12 months prior to screening;
- Severe hypoglycemic (grade 3 hypoglycemic) events within 6 months prior to screening, or 3 or more hypoglycemic events (blood glucose < 3.9 mmol/L) within 1 month prior to randomization, or recurrent hypoglycemia-related symptoms (1 or more per week) prior to randomization;
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
China1 site
The Affiliated Hospital of Qingdao University Phase I Clinical Research Center
Qingdao, Shandong, 266000
About this study
Official title: A Single-center, Randomized, Double-blind, Placebo-controlled, Multiple-ascending-dose Phase Id/IIa Study Evaluating the Safety, Tolerability, and Pharmacokinetics of ZT002 Injection in Adult Chinese Subjects With Type 2 Diabetes Mellitus (T2DM)
This study will comprise a randomized, double blind, placebo controlled, multiple ascending dose, safety, tolerability and pharmacokinetic study of ZT002 in subjects with type 2 diabetes mellitus (T2DM).
Read the detailed description
This study is a single-center, randomized, double-blind, placebo-controlled, multiple-ascending-dose Phase Id/IIa clinical study in Chinese T2DM subjects after diet and exercise intervention and/or treatment with oral hypoglycemic agent to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical efficacy of ZT002 injection in adult subjects with type 2 diabetes mellitus. Participants in each cohort will be randomized to receive a multiple SC doses of either ZT002 or matching placebo every 2 weeks.
- Conditions
- Type 2 Diabetes
- Being tested
- ZT002 Injection, ZT002 Placebo
- 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.
ZT002 InjectionDrug
Q2W, subcutaneous injection
ZT002 InjectionDrug
Q2W, subcutaneous injection
ZT002 PlaceboDrug
Participants will receive the same volume as the study drug in each cohort.
| Study group | Role | What they receive |
|---|---|---|
| ZT002 Injection dose 1 | Experimental | Dose 1 administered subcutaneously, Q2W Receives: Drug: ZT002 Injection |
| ZT002 Injection dose 2 | Experimental | Dose 2 administered subcutaneously, Q2W Receives: Drug: ZT002 Injection |
| ZT002 Placebo | Placebo comparator | Placebo administered subcutaneously, Q2W Receives: Drug: ZT002 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of treatment emergent adverse events and serious adverse events; Number of participants with injection site reaction.
Measured: up to 155days
Secondary outcomes (6)
Area under the concentration-time curve at the end of dosing interval(τ) at steady state (AUC0-τ,SS)
Measured: up to 155days
Time to Cmax at steady state (Tmax,ss)
Measured: up to 155days
Steady-state peak concentration (Css_max), mean steady-state concentration (Css_av)
Measured: up to 155days
Change from baseline of venous fasting plasma glucose
Measured: up to 155days
Change from baseline of weight (kg).
Measured: up to 155days
Incidence of anti-drug antibody against ZT002
Measured: up to 155days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start19 Feb 2024
- Primary completion22 Jul 2024
- Study completion5 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing QL Biopharmaceutical Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yu Cao, PhD, Principal investigator, The Affiliated Hospital of Qingdao UniversityChengqian Li, MD, Principal investigator, The Affiliated Hospital of Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07065032
- Sponsor's protocol ID
- BJQLZT002DM003
- Status last verified
- Jul 2025
- First submitted
- 6 Jun 2025
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Randomized, Double-blind, Placebo-controlled, Multiple-ascending-dose Phase Id/IIa Study Evaluating the Safety, Tolerability, and Pharmacokinetics of ZT002 Injection in Adult Chinese Subjects With Type 2 Diabetes Mellitus (T2DM)
- ClinicalTrials.gov ID
- NCT07065032
- Acronym / sponsor ID
- BJQLZT002DM003
- Conditions
- Type 2 Diabetes
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Beijing QL Biopharmaceutical Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 19 Feb 2024 (actual)
- Primary completion
- 22 Jul 2024 (actual)
- Study completion
- 5 Aug 2024 (actual)
- First posted
- 15 Jul 2025 (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 study will comprise a randomized, double blind, placebo controlled, multiple ascending dose, safety, tolerability and pharmacokinetic study of ZT002 in subjects with type 2 diabetes mellitus (T2DM).
Detailed description
This study is a single-center, randomized, double-blind, placebo-controlled, multiple-ascending-dose Phase Id/IIa clinical study in Chinese T2DM subjects after diet and exercise intervention and/or treatment with oral hypoglycemic agent to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical efficacy of ZT002 injection in adult subjects with type 2 diabetes mellitus. Participants in each cohort will be randomized to receive a multiple SC doses of either ZT002 or matching placebo every 2 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ZT002 Injection dose 1 | Experimental | Drug: ZT002 InjectionDose 1 administered subcutaneously, Q2W |
| ZT002 Injection dose 2 | Experimental | Drug: ZT002 InjectionDose 2 administered subcutaneously, Q2W |
| ZT002 Placebo | Placebo comparator | Drug: ZT002 PlaceboPlacebo administered subcutaneously, Q2W |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Males and females aged 18 to 65 years (inclusive, based on age at the time of signing the informed consent form);
- Body mass index (BMI) at screening ranges from 22-35 kg/m² (inclusive); BMI = Weight(kg)/ Height (m²).
- Type 2 diabetes mellitus has been diagnosed for ≥12 weeks according to the diagnostic and classification criteria for diabetes mellitus issued by the World Health Organization (WHO) in 1999 and the WHO Recommendations for Diagnosis Using Glycosylated Hemoglobin (HbA1c) (2011) supplemental diagnostic criteria; and one of the following conditions is met:
- At screening and before randomization: 7.0% ≤ glycosylated hemoglobin (HbA1c) ≤ 10.5% (hospital laboratory);
- At screening and before randomization: fasting venous blood glucose ≤ 13.9 mmol/L (hospital laboratory);
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| ZT002 InjectionQ2W, subcutaneous injection | Drug | ZT002 Injection dose 1 |
| ZT002 InjectionQ2W, subcutaneous injection | Drug | ZT002 Injection dose 2 |
| ZT002 PlaceboParticipants will receive the same volume as the study drug in each cohort. | Drug | ZT002 Placebo |
Primary outcome
Number of treatment emergent adverse events and serious adverse events; Number of participants with injection site reaction.
Time frame: up to 155days
6 secondary outcomes
Area under the concentration-time curve at the end of dosing interval(τ) at steady state (AUC0-τ,SS)
Time frame: up to 155days
Time to Cmax at steady state (Tmax,ss)
Time frame: up to 155days
Steady-state peak concentration (Css_max), mean steady-state concentration (Css_av)
Time frame: up to 155days
Change from baseline of venous fasting plasma glucose
Time frame: up to 155days
Change from baseline of weight (kg).
Time frame: up to 155days
Incidence of anti-drug antibody against ZT002
Time frame: up to 155days
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 Jul 2025.
- Individual participant dataSharing planned: No
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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.
Yu Cao, PhD principal investigator
The Affiliated Hospital of Qingdao University
Chengqian Li, MD principal investigator
The Affiliated Hospital of Qingdao University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ZT002 Injection in people with Type 2 Diabetes, run by Beijing QL Biopharmaceutical Co.,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 15 inclusion and 0 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 Jul 2025. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Number of treatment emergent adverse events and serious adverse events; Number of participants with injection site reaction. (time frame: up to 155days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jul 2025.