A Study of HS-20094 in Patients With T2DM

Sponsor
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Study ID
NCT06901648
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • HS-20094 — DRUG
    Administrated by subcutaneous injection once a week
  • Dulaglutide — DRUG
    Administrated by subcutaneous injection once a week
  • Palcebo — DRUG
    Administrated by subcutaneous injection once a week

Study Details

This is a 32-week, phase 2, randomized study, HS-20094 and placebo were double-blind, dulaglutide was open-label. Adults with T2D inadequately controlled with diet and exercise alone or with stable metformin, an HbA1c (glycated hemoglobin) ≥53 to ≤91 mmol/mol (≥7.0 % to≤10.5 %) were randomly assigned to receive 5 mg HS-20094, 10 mg HS-20094, 15 mg HS-20094, placebo, or 1.5 mg dulaglutide subcutaneously for 32 weeks. The primary endpoint was change in HbA1C from baseline to 32 weeks, and secondary endpoints included change in fasting glucose, body weight and several additional measures relevant for cardiovascular risks.

Key Dates

Start date
Feb 6, 2024
Status verified
Jul 2025
Primary completion
Mar 7, 2025
Completion
Apr 9, 2025

Study Design

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

Arms

  • Experimental: HS-20094 5mg
  • Experimental: HS-20094 10mg
  • Experimental: HS-20094 15mg
  • Active Comparator: Dulaglutide 1.5mg
  • Placebo Comparator: Placebo

Primary Outcome Measure

The change of HbA1c in the patients [ Time Frame: From baseline to week 32 ]

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