DelfaGLP-1 Atlas

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CompletedPhase 2

A Phase 2 Study to Evaluate the Efficacy and Safety of HS-20004 in Type 2 Diabetes Subjects.

A Phase 2, Multiple Centers, Double-blind, Placebo-Controlled, Randomised Study to Evaluate the Efficacy and Safety of HS-20004 in Type 2 Diabetes Subjects.

Asset

Noiiglutide / HS-20004 / SHR20004

Oral · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

128

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI 23-35•HbA1c 7.5-11%

Primary endpoint

•HbA1c

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 IDNCT03848793
Org study IDHS-20004-201

Timeline

Milestones

Study first posted2019-02-21actual
Study start2019-03-06actual
Primary completion2020-06-04actual
Study completion2020-12-14actual
Last update posted2022-11-07actual

Assets

Investigational agents

Noiiglutide / HS-20004 / SHR20004

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age70 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Type 2 diabetes diagnosed for more than 3 months
•HbA1c between 7.5 and 11.0 % (inclusive), and FPG ≥9.0mmol/l
•Body Mass Index (BMI) between 23 and 35 kg/m2(inclusive)

Exclusion criteria

：

•History or family history of drug allergy
•Subjects treated with any other anti-diabetes drug within 8 weeks before screening
•Participation in any other clinical trial of an investigational medicinal product within 3 months before screening
•Smoker or alcohol abuse
•Currently use or plan to use systemic corticosteroid
•History of recurrent severe hypoglycemia
•Type 1 diabetes or secondary diabetes mellitus
•Uncontrolled active or untreated hypertension
•History of pancreatitis (acute or chronic)
•Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN2) or Medullary Thyroid Carcinoma (MTC)
•Serious unconscious hypoglycemia history
•Within the past 6 months before screening any of the following: coronary artery revascularization, patients presently classified as being in New York Heart Association (NYHA) Class III or IV, myocardial infarction, stroke or unstable angina and/or persistent and clinically significant arrhythmias
•Female subject of childbearing potential who does not use an acceptable method of birth control, is pregnant or planning a pregnancy, or breastfeeding, or male subject who does not use an acceptable method of birth control
•Subject was not used for the study as determined by the Investigator

Endpoints (3)

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
2
Weight & body composition
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Change in Body Weight

Time frame:16 weeks treatment

change from baseline, improvement

Glycemic / diabetes

2 endpoints
Primary/protocol endpoint

HbA1c

Time frame:16 weeks treatment

descriptive

Secondary/protocol endpoint

Change in Fasting Plasma Glucose

Time frame:16 weeks treatment

change from baseline, improvement

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.