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

NCT ID: NCT07156500

Last Updated: 2025-09-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 204 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2027-05-30

Brief Summary

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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Group A

Group Type: EXPERIMENTAL

HS-20094 Injection

Intervention Type: DRUG

HS-20094 injected subcutaneously once weekly

Group B

Group Type: PLACEBO_COMPARATOR

HS-20094 Placebo Injection

Intervention Type: DRUG

HS-20094 Placebo injected subcutaneously once weekly

Group C

Group Type: EXPERIMENTAL

HS-20094 Injection

Intervention Type: DRUG

HS-20094 injected subcutaneously once weekly

Group D

Group Type: PLACEBO_COMPARATOR

HS-20094 Placebo Injection

Intervention Type: DRUG

HS-20094 Placebo injected subcutaneously once weekly

Interventions

HS-20094 Injection

HS-20094 injected subcutaneously once weekly

Intervention Type: DRUG

HS-20094 Placebo Injection

HS-20094 Placebo injected subcutaneously once weekly

Intervention Type: DRUG

HS-20094 Injection

HS-20094 injected subcutaneously once weekly

Intervention Type: DRUG

HS-20094 Placebo Injection

HS-20094 Placebo injected subcutaneously once weekly

Intervention Type: DRUG

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu Hansoh Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Hospital

Beijing, Beijing Municipality, China

Countries

China

Facility Contacts

Lixin Guo

Role: primary

glx1218@163.com

13901317569

Other Identifiers

HS-20094-302

Identifier Type: -

Identifier Source: org_study_id