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CompletedPhase 1, PHASE2

A Study of ZT002 Injection in Adult Chinese Subjects With Type 2 Diabetes Mellitus (T2DM)

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)

Asset

Zovaglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

-

Actual enrollment

27

Study population

Type 2 diabetes

Eligibility highlights

•BMI 22-35

Primary endpoint

•Number of treatment emergent adverse events and serious adverse events

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07065032
Org study IDBJQLZT002DM003

Timeline

Milestones

Study start2024-02-19actual
Primary completion2024-07-22actual
Study completion2024-08-05actual
Study first posted2025-07-15actual
Last update posted2025-07-15actual

Assets

Investigational agents

Who this study enrolls

Type 2 diabetes

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Males and females aged 18 to 65 years (inclusive, based on age at the time of signing the informed consent form);

2. Body mass index (BMI) at screening ranges from 22-35 kg/m² (inclusive); BMI = Weight(kg)/ Height (m²).

3. 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:

1. Controlled by diet and exercise for 12 weeks prior to screening, with no prior use of any hypoglycemic drugs

2. 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;

4. At screening and before randomization: 7.0% ≤ glycosylated hemoglobin (HbA1c) ≤ 10.5% (hospital laboratory);

5. 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):

1. 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;

2. 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;

3. 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;

4. 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;

5. Diabetic ketoacidosis (DKA) and hyperosmolar hyperglycemic syndrome (HHS), diabetic lactic acidosis, or hyperosmolar nonketotic diabetic coma within 12 months prior to screening;

6. Proliferative retinopathy, maculopathy, symptomatic diabetic neuropathy, intermittent claudication, and diabetic foot that are unstable or require treatment within 12 months prior to screening;

7. 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;

Endpoints (7)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK
4
Weight & body composition
1
Glycemic / diabetes
1
Other (unclassified)
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Change from baseline of weight (kg).

Time frame:up to 155days

change from baseline, improvement

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint

Change from baseline of venous fasting plasma glucose

Time frame:up to 155days

change from baseline, improvement

Safety / tolerability / PK

4 endpoints
Primary/protocol endpoint

Number of treatment emergent adverse events and serious adverse events; Number of participants with injection site reaction.

Time frame:up to 155days

event count, event

Secondary/protocol endpoint

Area under the concentration-time curve at the end of dosing interval(τ) at steady state (AUC0-τ,SS)

Time frame:up to 155days

concentration, descriptive

Secondary/protocol endpoint

Time to Cmax at steady state (Tmax,ss)

Time frame:up to 155days

time to event, event

Secondary/protocol endpoint

Incidence of anti-drug antibody against ZT002

Time frame:up to 155days

event count, event

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Steady-state peak concentration (Css_max), mean steady-state concentration (Css_av)

Time frame:up to 155days

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateNovember 5, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.