DRUG
HS-20094 Injection
HS-20094 injected subcutaneously once weekly
Status
Not yet recruiting
Phase
Phase 3
Enrollment
546
Locations
2
Results
Not posted
Publications
0
Study summary
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.
Interventions
DRUG
HS-20094 injected subcutaneously once weekly
DRUG
Dulaglutide injected subcutaneously once weekly
Timeline
First posted
Sep 5, 2025
Study start
Sep 30, 2025
Primary completion
Mar 30, 2027
Study completion
May 30, 2027
Results posted
Not reported
Registry updated
Sep 5, 2025
Outcomes
Change in HbA1c
Time frame · Week 0 to Week 44
Change from baseline in HbA1c after 44 weeks of treatment
Proportion of subjects with HbA1c<7.0% and ≤6.5%
Time frame · Week 0 to Week 44
Proportion of subjects with HbA1c\<7.0% and ≤6.5% after 44 weeks of treatment
Change in FPG
Time frame · Week 0 to Week 44
Change from baseline in FPG after 44 weeks of treatment
Change in body weight
Time frame · Week 0 to Week 44
Change from baseline in Change in body weight after 44 weeks of treatment
Proportion of subjects with weight loss ≥5% and ≥10%
Time frame · Week 0 to Week 44.
Proportion of subjects with weight loss ≥5% and ≥10% after 44 weeks of treatment
Change in HbA1c
Time frame · Week 0 to Week 52
Change from baseline in HbA1c after 52 weeks of treatment
Proportion of subjects with HbA1c<7.0% and ≤6.5%
Time frame · Week 0 to Week 52
Proportion of subjects with HbA1c\<7.0% and ≤6.5% after 52 weeks of treatment
Change in FPG
Time frame · Week 0 to Week 52
Change from baseline in FPG after 52 weeks of treatment
Change in body weight
Time frame · Week 0 to Week 52
Change from baseline in Change in body weight after 52 weeks of treatment
Proportion of subjects with weight loss ≥5% and ≥10%
Time frame · Week 0 to Week 52
Proportion of subjects with weight loss ≥5% and ≥10% after 52 weeks of treatment
Incidence and severity of adverse events
Time frame · Week 0 to Week 52+4 weeks follow-up
Severity (mild, moderate and severe) is assessed by investigator
Eligibility
Inclusion Criteria: 1. Males and females, Age ≥18 years at the time of signing informed consent. 2. 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; 3. Glycated hemoglobin was 7.5% ≤HbA1c ≤11.0%; 4. BMI ≥ 23 kg/m2. Exclusion Criteria: 1. Uncontrollable hypertension(with or without antihypertensive treatment) : systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg at screening. 2. Diagnosed or suspected with type 1 diabetes mellitus, special types of diabetes or secondary diabetes. 3. 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.). 4. 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) ; 5. Severe infection, severe trauma, or moderate-to-major surgery within 4 weeks before screening. 6. Participated in clinical trials of any drug or medical device within 12 weeks prior to screening, and participation in clinical trials is defined as signing informed consent and using investigational drugs (including placebo) or investigational medical devices; Or is still in the trial drug within 5 half-lives (whichever is Longer).
Study locations
China. Showing up to 24 locations stored in the fast local snapshot.
Shandong Provincial Hospital
Jinan, Shandong, China
Tianjin Medical University General Hospital (Zhu Xianyi Memorial Hospital)
Tianjin, Tianjn, China
Publications
No PMID-linked publications were present in this registry snapshot.
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