---
title: Safety, Tolerability,Pharmacokinetics(PK)and Pharmacodynamics(PD)Assessment of LCQ908 in Patients With Severe Hypertriglyceridemia
nct_id: NCT01146522
overall_status: COMPLETED
phase: PHASE1, PHASE2
sponsor: Novartis Pharmaceuticals
study_type: INTERVENTIONAL
primary_condition: Hyperlipoproteinemia
countries: Canada
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01146522.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01146522"
ct_last_update_post_date: 2020-12-17
last_seen_at: "2026-05-12T07:08:58.885Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Safety, Tolerability,Pharmacokinetics(PK)and Pharmacodynamics(PD)Assessment of LCQ908 in Patients With Severe Hypertriglyceridemia

**Official Title:** A Multiple-dose, Parallel Group Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LCQ908 in Patients With Severe Hypertriglyceridemia and Chylomicronemia (Phenotypes I and V)

**NCT ID:** [NCT01146522](https://clinicaltrials.gov/study/NCT01146522)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1, PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 8
- **Lead Sponsor:** Novartis Pharmaceuticals
- **Conditions:** Hyperlipoproteinemia
- **Start Date:** 2010-05
- **Completion Date:** 2011-10
- **CT.gov Last Update:** 2020-12-17

## Brief Summary

This study will assess safety, tolerability, and effect of LCQ908 on blood lipids in patients with severe hypertriglyceridemia.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 75 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Patients with hyperlipoproteinemia Type I or Type V willing and medically able to discontinue their lipid lowering medication (if prescribed).
* Non breast feeding women.
* Women of child bearing potential practicing appropriate contraception with a negative pregnancy test before dosing.

Exclusion Criteria:

Patients with:

* uncontrolled type 1 or type 2 diabetes mellitus,
* active pancreatitis (the month prior to study start),
* history of drug or alcohol abuse within the 12 months prior to dosing,
* or any surgical or medical condition, acute or unstable chronic disease which may, based on the investigator's opinion, jeopardize the patient in case of participation in the study.

Other protocol-defined inclusion/exclusion criteria may apply
```

## Arms

- **LCQ908** (EXPERIMENTAL)
- **Placebo** (PLACEBO_COMPARATOR)

## Interventions

- **LCQ908** (DRUG)
- **Placebo** (DRUG)

## Primary Outcomes

- **Fasting and postprandial plasma triglycerides** _(time frame: baseline and 3 weeks after initiation of each dose level (a test meal will be served at baseline and on Day 21 of treatment))_

## Secondary Outcomes

- **Blood concentration to characterize LCQ908 kinetics** _(time frame: serial blood samples will be collected from all patients enrolled in the study on Day 21 of treatment with each dose)_
- **Different blood lipid biomarkers (such as phospholipids, apolipoproteins, and free fatty acids)** _(time frame: after 3 weeks of treatment with each dose)_

## Locations (1)

- Novartis Investigative Site, Québec, Canada

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.novartis investigative site|québec||canada` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01146522.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01146522*  
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