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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
Lead sponsor
Asset
Dulaglutide
Subcutaneous · GLP-1 agonist
Listed sites
2
Recruiting sites
—
Enrollment
546
estimated
Study population
Type 2 diabetes
Key I/E criteria
•BMI ≥23•HbA1c ≤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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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
Weight & body composition
4 endpointsChange in body weight
Time frame:Week 0 to Week 44
Body weight, absolute change (kg)
change from baseline, improvement
Proportion of subjects with weight loss ≥5% and ≥10%
Time frame:Week 0 to Week 44.
≥10% weight-loss responders
threshold achievement, improvement
Change in body weight
Time frame:Week 0 to Week 52
Body weight, absolute change (kg)
change from baseline, improvement
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 endpointsChange in HbA1c
Time frame:Week 0 to Week 44
HbA1c, change
change from baseline, improvement
LOINC 4548-4
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
Change in FPG
Time frame:Week 0 to Week 44
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Change in HbA1c
Time frame:Week 0 to Week 52
HbA1c, change
change from baseline, improvement
LOINC 4548-4
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
Change in FPG
Time frame:Week 0 to Week 52
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Safety / tolerability / PK
1 endpointIncidence and severity of adverse events
Time frame:Week 0 to Week 52+4 weeks follow-up
Treatment-emergent AEs (any)
descriptive
Provenance
Sources
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.