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

NCT06148649 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 234

Last updated 2025-04-29

No results posted yet for this study

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

Interventions

DRUG

HEC88473, Placebo, Dulaglutide

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

Sponsors & Collaborators

  • Dongguan HEC Biopharmaceutical R&D Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-10
Primary Completion
2025-02-27
Completion
2025-04-23

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06148649 on ClinicalTrials.gov