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

NCT07156500 | Not Yet Recruiting Phase 3

• 1 other identifier: HS-20094-302
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c

  Change from baseline in HbA1c after 44 weeks of treatment

  Week 0 to Week 44

Secondary Outcomes (10)

• Proportion of subjects with HbA1c<7.0% and ≤6.5%

  Week 0 to Week 44

• Change in FPG

  Week 0 to Week 44

• Change in body weight

  Week 0 to Week 44

• Proportion of subjects with weight loss ≥5% and ≥10%

  Week 0 to Week 44

• Change in HbA1c

  Week 0 to Week 52

Study Arms (4)

Group A

EXPERIMENTAL

Drug: HS-20094 Injection

Group B

PLACEBO COMPARATOR

Drug: HS-20094 Placebo Injection

Group C

EXPERIMENTAL

Drug: HS-20094 Injection

Group D

PLACEBO COMPARATOR

Drug: HS-20094 Placebo Injection

Interventions

HS-20094 Injection DRUG

HS-20094 injected subcutaneously once weekly

Group A

HS-20094 Placebo Injection DRUG

HS-20094 Placebo injected subcutaneously once weekly

Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• % ≤ HbA1c ≤10.5% at screening.

You may not qualify if:

• 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) ；
• 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).

Sponsors & Collaborators

• Jiangsu Hansoh Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Beijing Hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2025
• First Posted: September 5, 2025
• Study Start: September 30, 2025
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): May 30, 2027
• Last Updated: September 5, 2025

Record last verified: 2025-08

Locations

CN (1)