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NCT01619332 · ClinicalTrials.gov registry record · Phase 1
Clinical Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LEZ763
A Phase 1 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 220
- Enrollment target
NCT01619332: Completed Phase 1 study, sponsored by Novartis Pharmaceuticals.
NCT01619332 is a Phase 1 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 220 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (267% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01619332, a Phase 1 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 220 participants
- Enrollment target
Study Summary
This study is a three part study to assess the safety and efficacy of LEZ763 on normal healthy volunteers and patients with Type 2 Diabetes.
Primary Outcome
An adverse event is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Adverse events will also be determined on the basis of clinical laboratory assessments, electrocardiographic evaluations and vital signs determinations.
Interventions
- DRUG Placebo
- DRUG Sitagliptin
- DRUG LEZ763
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 220 participants |
| Start Date | 2012-03 |
| Est. Completion | 2013-09 |
| Phase | Phase 1 |
What the finished NCT01619332 record still lists
NCT01619332 is an interventional study that assigns participants to a tested intervention. The registered 220 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (267% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01619332 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01619332 about?
NCT01619332 is a clinical study titled "Clinical Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LEZ763". This study is a three part study to assess the safety and efficacy of LEZ763 on normal healthy volunteers and patients with Type 2 Diabetes.
What is the current status of trial NCT01619332?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 220 participants. The study started on 2012-03. Estimated completion is 2013-09.
What interventions are being tested in trial NCT01619332?
The interventions under investigation include: Placebo (DRUG), Sitagliptin (DRUG), LEZ763 (DRUG).
Who is sponsoring clinical trial NCT01619332?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01619332's enrollment target sits among peer trials
220 230th of 2000 higher than 1,763 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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