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

Not Applicable

Not yet recruiting

• Conditions: Type 2 Diabetes
• Interventions: Drug: HS-20094 Injection; Drug: HS-20094 Placebo Injection

• Registration Number: NCT07156500
• Lead Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-28
• Study First Submitted QC: 2025-08-28
• Last Update Submitted: 2025-08-28
• Study First Posted: 2025-09-05
• Last Update Posted: 2025-09-05
• Study Start: 2025-09-30
• Primary Completion: 2027-03-30
• Study Completion: 2027-05-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 204

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	HS-20094 Injection	-
Group B	HS-20094 Placebo Injection	-
Group C	HS-20094 Injection	-
Group D	HS-20094 Placebo Injection	-

Primary Outcome Measures

Name	Time	Method
Change in HbA1c	Week 0 to Week 44	Change from baseline in HbA1c after 44 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects with HbA1c<7.0% and ≤6.5%	Week 0 to Week 52	Proportion of subjects with HbA1c\<7.0% and ≤6.5% after 52 weeks of treatment
Change in FPG	Week 0 to Week 52	Change from baseline in FPG after 52 weeks of treatment
Change in body weight	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%	Week 0 to Week 52	Proportion of subjects with weight loss ≥5% and ≥10% after 52 weeks of treatment
Change in HbA1c	Week 0 to Week 52	Change from baseline in HbA1c after 52 weeks of treatment
Incidence and severity of adverse events	Week 0 to Week 52+4 weeks follow-up	Severity (mild, moderate and severe) is assessed by investigator

Trial Locations

Locations (1)

Beijing Hospital; 🇨🇳 Beijing, Beijing Municipality, China