DelfaGLP-1 Atlas

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CompletedPhase 1, PHASE2

Multiple-dose Tolerability and Pharmacokinetic of IBI362 in Chinese Patients With T2DM

A Multiple Dose Human Tolerability and Pharmacokinetic Study of IBI362 in Chinese Patients With Type 2 Diabetes Mellitus and Poor Glycemic Control

Assets

Dulaglutide / Mazdutide

Listed sites

1

Recruiting sites

—

Enrollment

42

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI ≤35•HbA1c ≤11%

Primary endpoint

•Treatment-emergent AEs (any)

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 IDNCT04466904
Org study IDCIBI362A101

Timeline

Milestones

Study first posted2020-07-10actual
Study start2020-09-12actual
Primary completion2021-05-28actual
Study completion2021-05-28actual
Last update posted2021-07-23actual

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

* Eligibility Criteria： Inclusion Criiteria:

1. Male or female 18 to 75 years of age at the time of consent.

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

3. HbA1c 7.5% ≤ 11.0% by local laboratory at screening.

4. Body mass index 20 ≤ BMI ≤ 35 kg/m2.

Exclusion criteria

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

2. Ketoacidosis or lactic acidosis within 6 months prior to screening.

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

4. Acute myocardial infarction, unstable angina pectoris, coronary artery bypass grafting, coronary intervention (except diagnostic angiography), transient ischemic attack (TIA), cerebrovascular accident, acute and chronic heart failure within 6 months before screening.

5. Clinically symptomatic liver disease, acute or chronic hepatitis, or transaminases (ALT and AST) and alkaline phosphatase (ALP) > 2 times the upper limit of normal and total bilirubin above the upper limit of normal at screening.

6. The patient was previously diagnosed with autonomic neuropathy, manifested as urinary retention, resting tachycardia, orthostatic hypotension and diabetic diarrhea.

Endpoints (9)

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
5
Glycemic / diabetes
2
Other (unclassified)
2

Glycemic / diabetes

2 endpoints
Secondary/protocol endpoint

Evaluate the Fasting Blood Glucose (FBG ) of IBI362 in patients with T2DM

Time frame:From Baseline to week 12

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint/low confidence

Evaluate the C-peptide of IBI362 in patients with T2DM

Time frame:From Baseline to week 12

change from baseline, improvement

Safety / tolerability / PK

5 endpoints
Primary/protocol endpoint

To assess the number and incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of IBI362 compared with placebo

Time frame:From the first dose of study drug to week 19

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

The PK/PD parameters of IBI362 in patients with T2DM

Time frame:From Baseline to week 12

descriptive

Secondary/protocol endpoint

Evaluate the Peak Plasma Concentration (Cmax) of IBI362 in patients with T2DM

Time frame:From Baseline to week 12

Cmax

concentration, descriptive

Secondary/protocol endpoint

Evaluate the Area under the plasma concentration versus time curve (AUC) of IBI362 in patients with T2DM

Time frame:From Baseline to week 12

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Number of Participants With Anti-IBI362 Antibodies

Time frame:From the first dose of study drug to week 19

Immunogenicity (ADA)

descriptive

Other (unclassified)

2 endpoints
Secondary/protocol endpoint/low confidence

Evaluate the Glucagon of IBI362 in patients with T2DM

Time frame:From Baseline to week 12

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Evaluate the Insulin of IBI362 in patients with T2DM

Time frame:From Baseline to week 12

descriptive

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.