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Not yet recruitingPhase 3

A Phase 3 Study of HS-20094 in Patients With T2DM

A Study of HS-20094 Versus Dulaglutide Once Weekly as Add-on Therapy to Metformin Monotherapy or in Combination With SGLT2 Inhibitors in Participants With Type 2 Diabete

Asset

Dulaglutide

Subcutaneous · GLP-1 agonist

Listed sites

2

Recruiting sites

Enrollment

546

estimated

Study population

Type 2 diabetes

Key I/E criteria

BMI ≥23HbA1c ≤11%

Primary endpoint

HbA1c, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07156539
Org study IDHS-20094-303

Timeline

Milestones

Study first posted2025-09-05actual
Last update posted2025-09-05actual
Study start2025-09-30estimated
Primary completion2027-03-30estimated
Study completion2027-05-30estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Males and females, Age ≥18 years at the time of signing informed consent.

2. Stable daily dose(s) for ≥90 days prior to screening of : 1) Any metformin formulations ≥1500 mg daily or maximum tolerated (≥1000mg daily). 2) Any metformin formulations ≥1500 mg daily or maximum tolerated (≥1000mg daily) with one type of SGLT-2 inhibitors;

3. Glycated hemoglobin was 7.5% ≤HbA1c ≤11.0%;

4. BMI ≥ 23 kg/m2.

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).

Endpoints (11)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes
6
Weight & body composition
4
Safety / tolerability / PK
1

Weight & body composition

4 endpoints
Secondary/protocol endpoint

Change in body weight

Time frame:Week 0 to Week 44

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Week 0 to Week 44.

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Change in body weight

Time frame:Week 0 to Week 52

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Week 0 to Week 52

≥10% weight-loss responders

threshold achievement, improvement

Glycemic / diabetes

6 endpoints
Primary/protocol endpoint

Change in HbA1c

Time frame:Week 0 to Week 44

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

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

Time frame:Week 0 to Week 44

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in FPG

Time frame:Week 0 to Week 44

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change in HbA1c

Time frame:Week 0 to Week 52

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

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

Time frame:Week 0 to Week 52

threshold achievement, improvement

componentsHbA1c <7.0% achievement, HbA1c <6.5% achievement

LOINC 4548-4

Secondary/protocol endpoint

Change in FPG

Time frame:Week 0 to Week 52

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Incidence and severity of adverse events

Time frame:Week 0 to Week 52+4 weeks follow-up

Treatment-emergent AEs (any)

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.