A Phase 3 Study of HS-20094 in Patients With T2DM Inadequately Controlled With Diet and Exercise Alone

Hansoh Pharma

Status and phase: Not yet enrolling; Phase 3

Conditions: Type 2 Diabetes

Treatments: Drug: HS-20094 Placebo Injection; Drug: HS-20094 Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT07156500

HS-20094-302

Details and patient eligibility

About

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.

Enrollment: 204 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Males and females, Age ≥18 years at the time of signing informed consent.
2. Diagnosed with type 2 diabetes mellitus (T2DM) for at least 90 days prior to day of screening.
3. Treatment with Diet and Exercise alone at least 90 days prior to day of screening.
4. 7.5% ≤ HbA1c ≤10.5% at screening.

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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204 participants in 4 patient groups, including a placebo group

Group A

Experimental group

Treatment:

Drug: HS-20094 Injection

Drug: HS-20094 Injection

Group B

Placebo Comparator group

Treatment:

Drug: HS-20094 Placebo Injection

Drug: HS-20094 Placebo Injection

Group C

Experimental group

Treatment:

Drug: HS-20094 Injection

Drug: HS-20094 Injection

Group D

Placebo Comparator group

Treatment:

Drug: HS-20094 Placebo Injection

Drug: HS-20094 Placebo Injection