DelfaGLP-1 Atlas

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CompletedPhase 2

A Study of IBI362 in Chinese Patients With Type 2 Diabetes

A Randomized Phase II Study to Evaluate the Efficacy and Safety of IBI362 Versus Placebo and Dulaglutide in Chinese Patients With Type 2 Diabetes

Assets

Dulaglutide / Mazdutide

Listed sites

1

Recruiting sites

—

Enrollment

252

actual

Study population

Type 2 diabetes

Key I/E criterion

•HbA1c 7-10.5%

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 IDNCT04965506
Org study IDCIBI362A201

Timeline

Milestones

Study first posted2021-07-16actual
Study start2021-09-06actual
Primary completion2022-04-28actual
Study completion2022-06-11actual
Last update posted2023-12-27actual

Assets

Investigational agents

DulaglutideMazdutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Have type 2 diabetes (T2DM) for ≥6 months according to the Criteria for Diagnosing Type 2 Diabetes Mellitus (WHO 1999)

2. T2D patients with poorly controlled blood glucose treated with lifestyle intervention or stable dose of metformin (≥ 1000mg/day or maximum tolerated dose) within 3 months prior to screening.

3. Have HbA1c of 7.0% to 10.5%, inclusive(detected by local laboratory at screening).

4. Have a body mass index (BMI) between 20(Inclusive) and 40 kilograms per square meter

Exclusion criteria

1. Type 1 diabetes, special types of diabetes, or gestational diabetes.

2. Have uncontrolled diabetes defined as more than 2 episodes of ketoacidosis or hyperosmolar state requiring hospitalization in the 6 months prior to screening.

3. History of severe hypoglycemic episodes within 6 months prior to screening.

4. Have had any of the following within the last 6 months prior to screening: myocardial infarction (MI), unstable angina, coronary artery bypass graft, percutaneous coronary intervention (diagnostic angiograms are permitted),transient ischemic attack (TIA), cerebrovascular accident or decompensated congestive heart failure, or currently have New York Health Association Class III or IV heart failure.

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
Safety / tolerability / PK
1

Glycemic / diabetes

2 endpoints
Primary/protocol endpoint

The change in HbA1c from baseline to 20 weeks

Time frame:Baseline,20 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participants Achieving HbA1c Target of <7.0%

Time frame:Baseline,20 weeks

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Number of participants with treatment-related adverse events

Time frame:Baseline,25 weeks

Treatment-emergent AEs (any)

event count, event

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.