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NCT03375463 · ClinicalTrials.gov registry record · Phase 1
A Study of Tirzepatide (LY3298176) in Healthy Participants
A Phase 1 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 52
- Enrollment target
NCT03375463: Completed Phase 1 study, sponsored by Eli Lilly and Company.
NCT03375463 is a Phase 1 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 52 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03375463, a Phase 1 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 52 participants
- Enrollment target
Study Summary
This study has four parts. Each participant will enroll in one part. Part A: The purpose of Part A is to compare study drug tirzepatide solution formulation to a powder formulation mixed with water and given subcutaneously (SC) (just under the skin). Part A will measure how much of the study drug gets into the blood stream and how long it takes the body to get rid of it. Part B: The purpose of Part B is to evaluate the safety and tolerability of tirzepatide intravenous (IV) formulation when administered into a vein. Part C: The purpose of Part C is to evaluate the safety and tolerability of tirzepatide following multiple SC weekly doses of a solution. Part D: The purpose of Part D is to evaluate the safety and tolerability of tirzepatide following single IV bolus dose of lyophilized formulation. This study will last approximately 70 days for each part (Part A, Part B or Part D) and 92 days for Part C. This does not include screening. Screening is required within 28 days prior to the start of the study.
Primary Outcome
Pharmacokinetics (PK) Part A: Area under the concentration versus time curve \[AUC (0-∞)\] of tirzepatide.
Interventions
- DRUG Placebo
- DRUG Tirzepatide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2017-12-19 |
| Est. Completion | 2018-12-27 |
| Phase | Phase 1 |
What the finished NCT03375463 record still lists
NCT03375463 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03375463 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03375463 about?
NCT03375463 is a clinical study titled "A Study of Tirzepatide (LY3298176) in Healthy Participants". This study has four parts. Each participant will enroll in one part. Part A: The purpose of Part A is to compare study drug tirzepatide solution formulation to a powder formulation mixed with water and given subcutaneously (SC) (just under the skin). Part A will measure how much of the study drug g...
What is the current status of trial NCT03375463?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2017-12-19. Estimated completion is 2018-12-27.
What interventions are being tested in trial NCT03375463?
The interventions under investigation include: Placebo (DRUG), Tirzepatide (DRUG).
Who is sponsoring clinical trial NCT03375463?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03375463's enrollment target sits among peer trials
52 956th of 2000 higher than 1,032 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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