NCT06148649

Phase 2 Study of HEC88473 Injection in Subjects With Type 2 Diabetes Mellitus

A Phase 2, Multicenter, Randomised, Paralleled, Placebo-controlled (Double-blind) and Active Drug-controlled (Open) Study to Investigate Efficacy and Safety of HEC88473 Injection in Subjects With Type 2 Diabetes Mellitus

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 234 (actual)
• Sponsor: Dongguan HEC Biopharmaceutical R&D Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized, parallel, placebo- and active comparator-controlled phase 2 trial to evaluate the efficacy, safety, pharmacokinetics and immunogenicity in subjects with T2DM. Patients treated with diet and exercise alone, or in combination with stable metformin monotherapy (≥1500 mg/day or maximum tolerated dose ≥1000 mg/ day.), will be enrolled. Approximately 225 participants will be randomized. The study includes four stages: screening period (up to 2 weeks), lead-in period (2 weeks), treatment period (12 weeks) and safety follow-up period (3 weeks after treatment).

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	HEC88473, Placebo, Dulaglutide	T2DM subjects, receiving a weekly dose of HEC88473, placebo or dulaglutide.

Timeline

• Start date: 2023-12-10
• Primary completion: 2025-02-27
• Completion: 2025-04-23
• First posted: 2023-11-28
• Last updated: 2025-04-29

Locations

2 sites across 1 country: China