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NCT04039503 · ClinicalTrials.gov registry record · Phase 3
A Study of Tirzepatide (LY3298176) Versus Placebo in Participants With Type 2 Diabetes Inadequately Controlled on Insulin Glargine With or Without Metformin
A Phase 3 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 475
- Enrollment target
NCT04039503: Completed Phase 3 study, sponsored by Eli Lilly and Company.
NCT04039503 is a Phase 3 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 475 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (38% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04039503, a Phase 3 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 475 participants
- Enrollment target
Study Summary
The purpose of this study is to compare the safety and efficacy of the study drug tirzepatide to placebo in participants with type 2 diabetes that are already on insulin glargine, with or without metformin. Participants will administer tirzepatide or placebo along with their previous glucose lowering medications. The study will last approximately 47 weeks and may include about 23 visits.
Primary Outcome
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Baseline Metformin Use (Yes, No) + Pooled Country + Treatment + Time + Treatment\*Time (Type III sum of squares).
Interventions
- DRUG Placebo
- DRUG Tirzepatide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 475 participants |
| Start Date | 2019-08-30 |
| Est. Completion | 2021-01-13 |
| Phase | Phase 3 |
What the finished NCT04039503 record still lists
NCT04039503 is an interventional study that assigns participants to a tested intervention. The registered 475 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (38% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04039503 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04039503 about?
NCT04039503 is a clinical study titled "A Study of Tirzepatide (LY3298176) Versus Placebo in Participants With Type 2 Diabetes Inadequately Controlled on Insulin Glargine With or Without Metformin". The purpose of this study is to compare the safety and efficacy of the study drug tirzepatide to placebo in participants with type 2 diabetes that are already on insulin glargine, with or without metformin. Participants will administer tirzepatide or placebo along with their previous glucose lowerin...
What is the current status of trial NCT04039503?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 475 participants. The study started on 2019-08-30. Estimated completion is 2021-01-13.
What interventions are being tested in trial NCT04039503?
The interventions under investigation include: Placebo (DRUG), Tirzepatide (DRUG).
Who is sponsoring clinical trial NCT04039503?
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 NCT04039503's enrollment target sits among peer trials
475 808th of 2000 higher than 1,191 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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