NCT07065032

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)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Beijing QL Biopharmaceutical Co.,Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

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

Interventions

Type	Name	Description
DRUG	ZT002 Injection	Q2W, subcutaneous injection
DRUG	ZT002 Injection	Q2W, subcutaneous injection
DRUG	ZT002 Placebo	Participants will receive the same volume as the study drug in each cohort.

Timeline

• Start date: 2024-02-19
• Primary completion: 2024-07-22
• Completion: 2024-08-05
• First posted: 2025-07-15
• Last updated: 2025-07-15

Locations

1 site across 1 country: China