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A Study of Tirzepatide (LY3298176) in Japanese Participants With Type 2 Diabetes
A Multiple-Ascending Dose Study in Japanese Patients With Type 2 Diabetes Mellitus to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3298176
Lead sponsor
Asset
Tirzepatide
Subcutaneous · GLP-1 / GIP dual
Listed sites
2
Recruiting sites
—
Enrollment
48
actual
Study population
Type 2 diabetes
Key I/E criterion
•BMI 20-35
Primary endpoint
•Serious 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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
Exclusion criteria
Endpoints (8)
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 endpointsPharmacodynamics (PD): Change From Baseline to 8 Weeks in Fasting Plasma Glucose
Time frame:Baseline, Week 8
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Posted result
| Group | Value (mean), milligram per deciliter (mg/dL) | 95% CI |
|---|---|---|
| Placebo | -4.0 | — |
| 2.5 mg/5 mg/10 mg Tirzepatide (Cohort 1) | -77.5 | — |
| 5 mg/10 mg/15 mg Tirzepatide (Cohort 2) | -72.6 | — |
| 5 mg Tirzepatide (Cohort 3) | -51.7 | — |
Pharmacodynamics (PD): Change From Baseline to 8 Weeks in Fasting Plasma Glucose
Time frame:Baseline, Week 8
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Safety / tolerability / PK
6 endpointsNumber of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Time frame:Baseline through Day 85
Serious AEs (any)
event count, event
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Placebo | 0 | — |
| 2.5 mg/5 mg/10 mg Tirzepatide (Cohort 1) | 0 | — |
| 5 mg/10 mg/15 mg Tirzepatide (Cohort 2) | 0 | — |
| 5 mg Tirzepatide (Cohort 3) | 0 | — |
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Time frame:Baseline through Day 85
Serious AEs (any)
threshold achievement, event
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Tirzepatide
Time frame:Predose, 8, 24, 48, 72 and 168 hours post dose for Day 1 administration, and Predose, 8, 24, 48, and 168 hours post dose for Day 50 administration
Cmax
concentration, descriptive
Posted result
| Group | Value (geometric_mean), nanograms per milliliter (ng/mL) | 95% CI |
|---|---|---|
| 2.5 mg/5 mg/10 mg Tirzepatide (Cohort 1)Day 1 | 215 | — |
| Day 50 | 1520 | — |
| 5 mg/10 mg/15 mg Tirzepatide (Cohort 2)Day 1 | 442 | — |
| Day 50 | 2270 | — |
| 5 mg Tirzepatide (Cohort 3)Day 1 | 364 | — |
| Day 50 | 838 | — |
PK: Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide
Time frame:Predose, 8, 24, 48, 72 and 168 hours post dose for Day 1 administration, and Predose, 8, 24, 48, and 168 hours post dose for Day 50 administration
AUC₀–∞
concentration, descriptive
Posted result
| Group | Value (geometric_mean), nanograms * hours per mL (ng*hr/mL) | 95% CI |
|---|---|---|
| 2.5 mg/5 mg/10 mg Tirzepatide (Cohort 1)Day 1 | 26100 | — |
| Day 50 | 192000 | — |
| 5 mg/10 mg/15 mg Tirzepatide (Cohort 2)Day 1 | 54400 | — |
| Day 50 | 285000 | — |
| 5 mg Tirzepatide (Cohort 3)Day 1 | 48800 | — |
| Day 50 | 104000 | — |
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Tirzepatide
Time frame:Predose, 8, 24, 48, 72 and 168 hours post dose for Day 1 administration, and Predose, 8, 24, 48, and 168 hours post dose for Day 50 administration
Cmax
concentration, descriptive
PK: Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide
Time frame:Predose, 8, 24, 48, 72 and 168 hours post dose for Day 1 administration, and Predose, 8, 24, 48, and 168 hours post dose for Day 50 administration
AUC₀–∞
concentration, descriptive
Provenance
Sources
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.