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A Phase 3 Study of HS-20094 in Patients With T2DM

ConditionType 2 Diabetes
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorJiangsu Hansoh Pharmaceutical Co., Ltd.

About this trial

The study is being conducted to evaluate the efficacy and safety of HS-20094 once weekly (QW) in subjects with type 2 diabetes mellitus not adequately controlled with metformin monotherapy or in combination with SGLT2 inhibitors compared to Dulaglutide QW for 44 weeks and 52 weeks.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Males and females, Age ≥18 years at the time of signing informed consent.

Stable daily dose(s) for ≥90 days prior to screening of : 1) Any metformin formulations ≥1500 mg daily or maximum tolerated (≥1000mg daily). 2) Any metformin formulations ≥1500 mg daily or maximum tolerated (≥1000mg daily) with one type of SGLT-2 inhibitors;

Glycated hemoglobin was 7.5% ≤HbA1c ≤11.0%;

BMI ≥ 23 kg/m2.

Disqualifiers

Uncontrollable hypertension(with or without antihypertensive treatment) : systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg at screening.

Diagnosed or suspected with type 1 diabetes mellitus, special types of diabetes or secondary diabetes.

History of significant hematological disorders (e.g., sickle cell disease, hemolytic anemia, myelodysplastic syndrome, etc.) or other conditions causing hemolysis or instability of red blood cells (e.g., malaria, hypersplenism, etc.).

Presence of an endocrine disorder or history that may significantly affect bady weight(e.g., Cushing's syndrome, hypothyroidism or hyperthyroidism, except hypothyroidism if thyroid hormone replacement dose has been stable for at least 6 months) ；

Trial design

Design model

Parallel

Treatments tested in this trial

  • HS-20094 Injection

    Drug

    HS-20094 injected subcutaneously once weekly

  • Dulaglutide Injection

    Drug

    Dulaglutide injected subcutaneously once weekly

Treatment groups

546 Participants
are divided into 3 treatment groups
Group A: Treatment Group AExperimental treatment 1 intervention
Group B: Treatment Group BExperimental treatment 1 intervention
Group C: Treatment Group CActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in HbA1c

Change from baseline in HbA1c after 44 weeks of treatment

Time frame
Week 0 to Week 44

Secondary outcomes

1

Proportion of subjects with HbA1c<7.0% and ≤6.5%

Proportion of subjects with HbA1c\<7.0% and ≤6.5% after 44 weeks of treatment

Time frame
Week 0 to Week 44
2

Change in FPG

Change from baseline in FPG after 44 weeks of treatment

Time frame
Week 0 to Week 44
3

Change in body weight

Change from baseline in Change in body weight after 44 weeks of treatment

Time frame
Week 0 to Week 44
4

Proportion of subjects with weight loss ≥5% and ≥10%

Proportion of subjects with weight loss ≥5% and ≥10% after 44 weeks of treatment

Time frame
Week 0 to Week 44.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: