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NCT03496298 · ClinicalTrials.gov registry record · Phase 3
Effect of Efpeglenatide on Cardiovascular Outcomes
A Phase 3 study, sponsored by Sanofi.
- Terminated
- Registry status
- Phase 3
- Development phase
- 4,076
- Enrollment target
NCT03496298: Clinical Trial Phase 3 study, sponsored by Sanofi.
NCT03496298 is a Phase 3 study that was terminated before completion, run by Sanofi. The registered enrollment target is 4,076 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (428% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03496298, a Phase 3 study, was terminated before completion, sponsored by Sanofi.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 4,076 participants
- Enrollment target
Study Summary
Primary Objective: To demonstrate that efpeglenatide 4 and 6 mg was noninferior to placebo on 3-point major adverse cardiac events (MACE) in Type 2 diabetes mellitus (T2DM) participants at high cardiovascular (CV) risk. Secondary Objectives: To demonstrate that efpeglenatide 4 and 6 mg was superior to placebo in T2DM participants with high CV risk on the following parameters: * 3-point MACE. * Expanded CV outcome. * Composite outcome of new or worsening nephropathy. To assess the safety and tolerability of efpeglenatide 4 and 6 mg, both added to standard of care in T2DM participants at high CV risk.
Primary Outcome
All MACE positively adjudicated by the clinical endpoint committee (CEC) were used in the analysis of the composite outcome of first occurrence to CV death, non-fatal myocardial infarction (MI), and non-fatal stroke. Kaplan-Meier curves of the cumulative event rate by treatment groups were used to depict the first occurrence of MACE over time. The event rate per 100 participant-years (calculated by 100\*number of participants with events/sum of time at risk (days) over all participants/365.25) m
Interventions
- DRUG Placebo
- DRUG Efpeglenatide (SAR439977)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4,076 participants |
| Start Date | 2018-04-27 |
| Est. Completion | 2020-12-10 |
| Phase | Phase 3 |
Why NCT03496298 stopped before completion
NCT03496298 is an interventional study that assigns participants to a tested intervention. Its 4,076 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (428% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03496298 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03496298 about?
NCT03496298 is a clinical study titled "Effect of Efpeglenatide on Cardiovascular Outcomes". Primary Objective: To demonstrate that efpeglenatide 4 and 6 mg was noninferior to placebo on 3-point major adverse cardiac events (MACE) in Type 2 diabetes mellitus (T2DM) participants at high cardiovascular (CV) risk. Secondary Objectives: To demonstrate that efpeglenatide 4 and 6 mg was superi...
What is the current status of trial NCT03496298?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 4,076 participants. The study started on 2018-04-27. Estimated completion is 2020-12-10.
What interventions are being tested in trial NCT03496298?
The interventions under investigation include: Placebo (DRUG), Efpeglenatide (SAR439977) (DRUG).
Who is sponsoring clinical trial NCT03496298?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03496298's enrollment target sits among peer trials
4,076 61st of 2000 higher than 1,940 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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