DelfaGLP-1 Atlas

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CompletedPhase 2

A Study of HS-20094 in T2DM Participants

A Multiple-dose, Randomized, Double-blind, Placebo and Positive Controlled Phase IIa Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HS-20094 in Subjects With Type 2 Diabetes.

Asset

Semaglutide

GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

54

actual

Study population

Type 2 diabetes

Key I/E criterion

•HbA1c 7.5-10%

Primary endpoints

•Treatment-emergent AEs (any)•Changes of laboratory tests blood routine, urine routine, blood biochemistry•Changes ECG examination (pr interval, rr interval, qrs duration, qtc f interval)

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 IDNCT06118008
Org study IDHS-20094-201

Timeline

Milestones

Study start2023-05-31actual
Study first posted2023-11-07actual
Primary completion2024-01-04actual
Study completion2024-01-04actual
Last update posted2025-08-03actual

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age20 Years
Maximum age65 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Male or female subjects,20-65 years of age at the time of signing informed consent.
•Type 2 diabetes mellitus diagnosed for at least 3 months before the screening visit.
•Treated with conventional lifestyle intervention and stable treatment with metformin ( ≥ 1000 mg/day) at least 3 months prior to screening HbA1c 7.5-10%(both inclusive)at screening visit.

Exclusion criteria

•A history of type 1 diabetes, specific diabetes, or secondary diabetes.
•Presence of-clinically significant lab or ECG results that may affect the evaluation of the efficacy or safety of the study drug at screening visit.
•Acute or chronic pancreatitis at any time before screening, or serum lipase/amylase above the upper limit of normal at screening.
•A history of grade 2 hypoglycemia(blood glucose 3.0 mmol/L)or grade 3 hypoglycemia(hypoglycemia with a serious event of consciousness and/or physical alteration requiring assistance from another person for recovery)within 6 months before screening.
•Diabetid ketoacidosis or hyperosmolar coma or lactic acidosis requiring hospitalization occurred within 6 months before screening.
•Severe infection such as diabetic foot infection, pneumonia, or sepsis within 30 days before screening.
•Uncontrollable hypertension.
•History of acute cardiovascular and cerebrovascular diseases within 6 months prior to screening.
•Any organ-system malignancies developed within 5 years except for cured local basal cell carcinoma of the skin and carcinoma in situ of the cervix.
•Pregnant or lactating woman.
•In the investigator's judgment, there were circumstances that affected subject safety or otherwise interfered with the evaluation of results.

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

Safety / tolerability / PK
7
Cardiometabolic biomarkers
2
Glycemic / diabetes
1
Other (unclassified)
1

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint

Pharmacodynamics (PD): HbA1c

Time frame:Baseline to Day 29

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Cardiometabolic biomarkers

2 endpoints
Primary/protocol endpoint

The changes in Blood pressure

Time frame:From Baseline to Day 57

change from baseline, improvement

Primary/protocol endpoint

Pulse rate

Time frame:From Baseline to Day 57

Heart rate, change

change from baseline, improvement

Safety / tolerability / PK

7 endpoints
Primary/protocol endpoint

Incidence of adverse event (AE), serious adverse event (SAE), AE leading to study discontinuation, AE severity and relation with study drug

Time frame:From Baseline to Day 57.

Treatment-emergent AEs (any)

descriptive

Primary/protocol endpoint

The number of participants with changes of laboratory tests blood routine, urine routine, blood biochemistry, coagulation function

Time frame:From Baseline to Day 57

descriptive

Primary/protocol endpoint

The changes ECG examination assessed by PR, R-R, QRS and QTcF

Time frame:From Baseline to Day 57

change from baseline, descriptive

componentspr interval, rr interval, qrs duration, qtc f interval

Primary/protocol endpoint

Temperature

Time frame:From Baseline to Day 57

change from baseline, descriptive

Secondary/protocol endpoint

Pharmacokinetics (PK): Cmax of HS-20094

Time frame:Baseline to Day 57

Cmax

concentration, descriptive

Secondary/protocol endpoint

Pharmacokinetics (PK): Tmax of HS-20094

Time frame:Baseline to Day 57

Tmax

descriptive

Secondary/protocol endpoint

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of HS-20094

Time frame:Baseline to Day 57

AUC₀–∞

concentration, descriptive

Other (unclassified)

1 endpoint
Primary/protocol endpoint/low confidence

Respiratory rate

Time frame:From Baseline to Day 57

change from baseline, 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.