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)
Lead sponsor
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
Timeline
Milestones
Assets
Investigational agents
Who this study enrolls
Who can enroll
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
Weight & body composition
1 endpointChange from baseline of weight (kg).
Time frame:up to 155days
change from baseline, improvement
Glycemic / diabetes
1 endpointChange from baseline of venous fasting plasma glucose
Time frame:up to 155days
change from baseline, improvement
Safety / tolerability / PK
4 endpointsNumber of treatment emergent adverse events and serious adverse events; Number of participants with injection site reaction.
Time frame:up to 155days
event count, event
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
Time to Cmax at steady state (Tmax,ss)
Time frame:up to 155days
time to event, event
Incidence of anti-drug antibody against ZT002
Time frame:up to 155days
event count, event
Other (unclassified)
1 endpointSteady-state peak concentration (Css_max), mean steady-state concentration (Css_av)
Time frame:up to 155days
concentration, descriptive
Provenance
Sources
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.