DelfaGLP-1 Atlas

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CompletedPhase 1

Clinical Study of IBI362 in Healthy Chinese Male Subjects

Clinical Study to Evaluate the Pharmacokinetics and Safety of IBI362 Lyophilized Powder and IBI362 Liquid Formulation in Healthy Chinese Male Subjects

Asset

Mazdutide

Subcutaneous · GLP-1 / glucagon dual

Listed sites

1

Recruiting sites

—

Enrollment

24

actual

Study population

Healthy volunteers

Key I/E criteria

•BMI ≤26•Male•Healthy volunteers

Primary endpoint

•Evaluate the PK parameters of IBI362 in healthy Chinese male subjects

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 IDNCT04773977
Org study IDCIBI362B102

Timeline

Milestones

Study first posted2021-02-26actual
Study start2021-03-03actual
Primary completion2021-03-09actual
Study completion2021-06-17actual
Last update posted2021-07-08actual

Assets

Investigational agents

Mazdutide

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age20 Years
Maximum age45 Years
SexMale
Healthy volunteersAccepted

Inclusion criteria

1. 20 years old≤ Healthy males≤45 years old

2. 19 kilograms per meter squared (kg/m²)≤Body Mass Index≤26 kg/m²

3. Willing and agreeable to commit to the duration of the study and undergo study procedures as instructed by the clinic staff

Exclusion criteria

1. Subjects who have previously completed or discontinued from this study, or who have used IBI362.

2. Abnormal vital signs and physical examination during the screening period;

3. Having cardiovascular, respiratory, liver, kidney, digestive, endocrine, hematologic, neurological, or muscle degenerative diseases can significantly affect drug absorption, metabolism, or elimination, or participation in the study increases risk or interferes with data interpretation.

4. Have a previous or current mental illness.

5. A family history of medullary thyroid carcinoma or multiple endocrine tumor syndrome type 2.

6. There are other factors judged by the investigators that are not suitable for inclusion in this study.

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.

Safety / tolerability / PK

3 endpoints
Primary/protocol endpoint

Evaluate the PK parameters of IBI362 in healthy Chinese male subjects

Time frame:From the first dose of study drug until 8 weeks

Cmax

concentration, descriptive

Primary/protocol endpoint

Evaluate the PK parameters of IBI362 in healthy Chinese male subjects

Time frame:From the first dose of study drug until 8 weeks

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Number of Participants With Adverse Events

Time frame:From the first dose of study drug until 8 weeks

Treatment-emergent AEs (any)

event count, event

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.