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

Sponsor
Dongguan HEC Biopharmaceutical R&D Co., Ltd.
Study ID
NCT06148649
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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).

Key Dates

Start date
Dec 10, 2023
Status verified
Apr 2025
Primary completion
Feb 27, 2025
Completion
Apr 23, 2025

Study Design

Enrollment
234 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: HEC88473 dose1
    T2DM subjects, receiving a weekly dose of HEC88473 dose1
  • Experimental: HEC88473 dose2
    T2DM subjects, receiving a weekly dose of HEC88473 dose2
  • Experimental: HEC88473 dose3
    T2DM subjects, receiving a weekly dose of HEC88473 dose3
  • Placebo Comparator: Placebo
    T2DM subjects, receiving a weekly dose of placebo
  • Active Comparator: Dulaglutide
    T2DM subjects, receiving a weekly dose of dulaglutide

Primary Outcome Measure

Change from baseline of HbA1c at week 12 [ Time Frame: Baseline to week 12 ]

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