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A Phase 3 Study of HS-20094 in Patients With T2DM Inadequately Controlled With Diet and Exercise Alone | Clinical Trials | Clareo Health

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

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

NCT07156500•Jiangsu Hansoh Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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).

Locations (1)

Beijing Hospital

Beijing, Beijing Municipality, China

Key Dates

Start Date

September 30, 2025

Primary Completion Date

March 30, 2027

Completion Date

May 30, 2027

Last Updated

September 5, 2025

Enrollment

204

ESTIMATED participants

Conditions

Type 2 Diabetes

Interventions

HS-20094 Injection

DRUG

HS-20094 Placebo Injection

DRUG

HS-20094 Injection

DRUG

HS-20094 Placebo Injection

DRUG

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

View study

RECRUITINGPHASE2

Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)

NCT07296484

Type 2 DiabetesCortisol Excess

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 5, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Feasibility of a Tailored Online Self-compassion Intervention

Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)

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