Phase 1
Completed N=65
A Research Study Looking at Similarity Between Tirzepatide Versions for Different Injection Devices
Healthy
Source: ClinicalTrials.gov NCT05810597 ↗
Enrolled (actual)
65
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcomePrimary: Pharmacokinetics (PK): Maximum Concentration (Cmax) of Tirzepatide — 647; 524 nanograms per milliliter (ng/mL)
Summary
The main purpose of this study is to look at the amount of the study drug, tirzepatide, that gets into the blood stream and how long it takes the body to get rid of it when given using two different devices. The study will also evaluate the safety and tolerability of tirzepatide and information about any side effects experienced will be collected. For each participant, the total duration of the study will be approximately 14 weeks, including screening.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics (PK): Maximum Concentration (Cmax) of Tirzepatide |
647; 524 | — |
| PRIMARY PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Time t, Where t is the Last Time Point With a Measurable Concentration (AUC[0-t]) of Tirzepatide |
124000; 118000 | — |
| PRIMARY PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Tirzepatide |
126000; 119000 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy males or non-pregnant females as determined by medical history, physical examination, and other screening procedures
- Body mass index (BMI) between 18.5 and 30.0 kilograms per meter squared (kg/m²), inclusive, at screening
- Have blood pressure, pulse rate, blood and urine laboratory test results that are acceptable for the study
- Are agreeable to receiving study treatment by injections under the skin
- Are agreeable to following study contraception requirements
Exclusion Criteria
- Have or used to have health problems that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
- Smoke more than the equivalent of 10 cigarettes per day
- Is a known user of drugs of abuse
Data sourced from ClinicalTrials.gov (NCT05810597). 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.