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

NCT06148649 · Completed

Last updated 2026-05-28

This clinical trial tests an investigational injection called HEC88473 in adults with type 2 diabetes to see how it affects their blood sugar levels over 12 weeks.

Status Completed The study has finished.

Phase Phase 2 Tests whether it works and watches safety in a moderate group.

Type Interventional (clinical trial)

Design Randomized, quadruple-blind treatment study

Participants 234 people

Who can join Ages 18–75 · all sexes

Timeline Started 2023-12 · est. completion 2025-04

Where 2 sites · China

What this study is testing ClinicalTrials.gov NCT06148649 ↗

Description as written by the study sponsor.

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).

Treatments tested

HEC88473, Placebo, Dulaglutide Drug

T2DM subjects, receiving a weekly dose of HEC88473, placebo or dulaglutide.

Main thing measured	Change from baseline of HbA1c at week 12
Sponsor	Dongguan HEC Biopharmaceutical R&D Co., Ltd.
Conditions studied	Type 2 Diabetes
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT06148649 ↗