Tests HS-20094 injection in adults with type 2 diabetes not controlled by diet alone
Tests HS-20094 injection against a placebo in adults with type 2 diabetes.
Plain-language title generated from the registry record
Registry title: A Phase 3 Study of HS-20094 in Patients With T2DM Inadequately Controlled With Diet and Exercise Alone
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 3
Where in China
- Beijing HospitalBeijing, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Trial code
- NCT07156500
- Record updated
- 5 September 2025
- Original description
This is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study to evaluate the efficacy and safety of HS-20094 injection in subjects with type 2 diabetes who have inadequate glycemic control with diet and exercise alone. The primary objective of this study is to evaluate the effectiveness of HS-20094 compared to placebo in controlling blood glucose levels after 44 weeks and 52 weeks treatment.Read full original descriptionShow less
A Multicenter, Randomized, Double-Blind, Placebo- Parallel Controlled, Phase III Study to Evaluate the Efficacy and Safety of HS-20094 Injection in Subjects With Type 2 Diabetes, Inadequately Controlled With Diet and Exercise Alone
This is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study to evaluate the efficacy and safety of HS-20094 injection in subjects with type 2 diabetes who have inadequate glycemic control with diet and exercise alone. The primary objective of this study is to evaluate the effectiveness of HS-20094 compared to placebo in controlling blood glucose levels after 44 weeks and 52 weeks treatment.
Inclusion: Males and females, Age ≥18 years at the time of signing informed consent; Diagnosed with type 2 diabetes mellitus (T2DM) for at least 90 days prior to day of screening; Treatment with Diet and Exercise alone at least 90 days prior to day of screening; 7.5% ≤ HbA1c ≤10.5% at screening.
Exclusion: Severe infection, severe trauma, or moderate-to-major surgery within 4 weeks before screening; 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); 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) ；.