Phase 1
Completed N=48
A Study of Tirzepatide (LY3298176) in Japanese Participants With Type 2 Diabetes
Source: ClinicalTrials.gov NCT03322631 ↗Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Mar 2023
Primary outcomePrimary: Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration — 0; 0; 0; 0 Participants
Summary
The purposes of this study are to determine:
* The safety of tirzepatide and any side effects that might be associated with it.
* How much tirzepatide gets into the bloodstream and how long it takes the body to remove it.
* How tirzepatide affects the levels of blood sugar.
This study includes eight weekly doses of tirzepatide or placebo given as subcutaneous (SC) injections just under the skin. The study will last about 16 weeks (total), including screening and follow-up. This study is for research purposes only and is not intended to treat any medical conditions.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration |
0; 0; 0; 0 | — |
| SECONDARY Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Tirzepatide |
215; 442; 364; 1520; 2270; 838 | — |
| SECONDARY PK: Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide |
26100; 54400; 48800; 192000; 285000; 104000 | — |
| SECONDARY Pharmacodynamics (PD): Change From Baseline to 8 Weeks in Fasting Plasma Glucose |
-4.0; -77.5; -72.6; -51.7 | — |
Eligibility Criteria
Inclusion Criteria
- Have T2DM controlled with diet and exercise alone or are stable on a single oral antidiabetic medication (metformin or dipeptidyl peptidase [DPP]-IV inhibitors)
- Have a body mass index of 20.0 to 35.0 kilograms per square meter, inclusive
Exclusion Criteria
- Have known allergies to tirzepatide, glucagon-like peptide (GLP)-1 analogs, or related compounds
- Have had more than 1 episode of severe hypoglycemia, as defined by the American Diabetes Association criteria, within 6 months before entry into the study or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms
- Have an abnormality in the 12-lead electrocardiogram at screening that, in the opinion of the investigator, increases the risks associated with participating in the study
- Have a history or presence of pancreatitis or gastrointestinal (GI) disorder or any GI disease which impacts gastric emptying or could be aggravated by GLP-1 analogs or DPP-IV inhibitors
Data sourced from ClinicalTrials.gov (NCT03322631). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.