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

NCT07065032 | Completed Phase 1

• 1 other identifier: BJQLZT002DM003
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

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

  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)

  up to 155days

• Time to Cmax at steady state (Tmax,ss)

  up to 155days

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

  up to 155days

• Change from baseline of venous fasting plasma glucose

  up to 155days

• Change from baseline of weight (kg).

  up to 155days

Study Arms (3)

ZT002 Injection dose 1

EXPERIMENTAL

Dose 1 administered subcutaneously, Q2W

Drug: ZT002 Injection

ZT002 Injection dose 2

EXPERIMENTAL

Dose 2 administered subcutaneously, Q2W

Drug: ZT002 Injection

ZT002 Placebo

PLACEBO COMPARATOR

Placebo administered subcutaneously, Q2W

Drug: ZT002 Placebo

Interventions

ZT002 Injection DRUG

Q2W, subcutaneous injection

ZT002 Injection dose 1

ZT002 Placebo DRUG

Participants will receive the same volume as the study drug in each cohort.

ZT002 Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);
• At screening and before randomization: fasting venous blood glucose ≤ 13.9 mmol/L (hospital laboratory);

You may not qualify if:

• 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;

Sponsors & Collaborators

• Beijing QL Biopharmaceutical Co.,Ltd: lead

Study Sites (1)

The Affiliated Hospital of Qingdao University Phase I Clinical Research Center

Qingdao, Shandong, 266000, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Yu Cao, PhD

  The Affiliated Hospital of Qingdao University

  PRINCIPAL INVESTIGATOR

• Chengqian Li, MD

  The Affiliated Hospital of Qingdao University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2025
• First Posted: July 15, 2025
• Study Start: February 19, 2024
• Primary Completion: July 22, 2024
• Study Completion: August 5, 2024
• Last Updated: July 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)