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NCT03131479 · ClinicalTrials.gov registry record · Phase 2

Study of PK/PD, Safety and Tolerability of LIK066 in Patients With Decreased Renal Function.

A Phase 2 study, sponsored by Novartis Pharmaceuticals.

Completed
Registry status
Phase 2
Development phase
53
Enrollment target

NCT03131479: Completed Phase 2 study, sponsored by Novartis Pharmaceuticals.

NCT03131479 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 53 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03131479, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.

COMPLETED
Registry status
Phase 2
Development phase
53 participants
Enrollment target

Study Summary

The purpose of this trial was to evaluate whether the study drug, LIK066, causes glucose excretion in urine in patients with varying degrees of decreased kidney function and in subjects with normal kidney function. Blood samples were collected to measure the concentrations of LIK066 and to study the pharmacokinetics of LIK066. Pharmacokinetics is meant to study how LIK066 is absorbed, distributed and eliminated, in other words what the body does to the drug. The results of this study may be used to help determine whether LIK066 can be used to treat people with reduced kidney function and the proper dosing regimen.

Primary Outcome

Urine was collected over 24 h to measure Urinary Glucose Excretion (UGE) at baseline (Day -1), following a single dose (Day 1) and at the end of the 7-day treatment (Day 7) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function.

Interventions

  • DRUG LIK066

Trial Details

FieldValue
Enrollment Target 53 participants
Start Date 2017-04-28
Est. Completion 2018-01-16
Phase Phase 2
Novartis Pharmaceuticals

1,375 total trials

What the finished NCT03131479 record still lists

NCT03131479 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (60% lower).

The record links to 0 conditions, and to 1 intervention - of which LIK066 is the first listed.

NCT03131479 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03131479 about?

NCT03131479 is a clinical study titled "Study of PK/PD, Safety and Tolerability of LIK066 in Patients With Decreased Renal Function.". The purpose of this trial was to evaluate whether the study drug, LIK066, causes glucose excretion in urine in patients with varying degrees of decreased kidney function and in subjects with normal kidney function. Blood samples were collected to measure the concentrations of LIK066 and to study the...

What is the current status of trial NCT03131479?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 53 participants. The study started on 2017-04-28. Estimated completion is 2018-01-16.

What interventions are being tested in trial NCT03131479?

The interventions under investigation include: LIK066 (DRUG).

Who is sponsoring clinical trial NCT03131479?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03131479's enrollment target sits among peer trials

53 1171st of 2000 higher than 820 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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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Source: ClinicalTrials.gov NCT03131479, the US trial registry maintained by the National Library of Medicine. NCT03131479 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.