Trial · NCT01556906
Safety, Tolerability and Efficacy of Microsomal Triglyceride Protein (MTP) Inhibitor
NCT01556906, Phase 2, Completed, Aegerion Pharmaceuticals, Inc.; results first posted 2013-02-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety, Tolerability and Efficacy of Microsomal Triglyceride Protein (MTP) Inhibitor. Trials, record NCT01556906. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01556906
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety, Tolerability and Efficacy of Microsomal Triglyceride Protein (MTP) Inhibitor
- NCT number
- NCT01556906
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 6 participants, actual
- Lead sponsor
- Aegerion Pharmaceuticals, Inc.
- Conditions
- Homozygous Familial Hypercholesterolemia
- Interventions
- Lomitapide
- First posted
- 2012-03-19
- Last updated
- 2013-04-10
- Results first posted
- 2013-02-22
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | LDL-C | Up to 16 weeks of treatment comapred to Baseline | Percent change in LDL-C compared to Baseline. |
| Secondary | Absolute Change From Baseline in Alanine Aminotransferase (ALT) | Baseline and 16 weeks of treatment | Absolute change from Baseline in ALT |
| Secondary | Absolute Change From Baseline in Aspartate Aminotransferase (AST) | Baseline and 16 weeks of treatment | Absolute change from Baseline in AST |
| Secondary | Absolute Change From Baseline in Total Bilirubin | Baseline and 16 weeks of treatment | Absolute change from Baseline in total bilirubin |
| Secondary | Absolute Change From Baseline in Hepatic Fat Percent | Baseline and 16 weeks of treatment | Absolute change from Baseline in hepatic fat percent |
| Secondary | Absolute Change From Baseline in Forced Expiratory Volume During 1 Second (FEV1) | Baseline and 16 weeks of treatment | Absolute change from Baseline in FEV1 |
| Secondary | Absolute Change From Baseline in Carbon Monoxide Lung Diffusing Capacity (DLCO)(a Pulmonary Function Test) | Baseline and 16 weeks of treatment | Absolute change from Baseline in DLCO |
| Secondary | Absolute Change From Baseline in Vitamin A | Baseline and 16 weeks of treatment | Absolute change from Baseline in vitamin A |
| Secondary | Absolute Change From Baseline in Vitamin E | Baseline and 16 weeks of treatment | Absolute change from Baseline in vitamin E |
| Secondary | Absolute Change From Baseline in Vitamin D | Baseline and 16 weeks of treatment | Absolute Change From Baseline in Vitamin D |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | LDL-C | Up to 16 weeks of treatment comapred to Baseline | All patients treated | percentage change in LDL-C | MEAN |
| SECONDARY | Absolute Change From Baseline in Alanine Aminotransferase (ALT) | Baseline and 16 weeks of treatment | All patients treated | U/L | MEAN |
| SECONDARY | Absolute Change From Baseline in Aspartate Aminotransferase (AST) | Baseline and 16 weeks of treatment | All patients treated | U/L | MEAN |
| SECONDARY | Absolute Change From Baseline in Total Bilirubin | Baseline and 16 weeks of treatment | All patients treated | mg/dL | MEAN |
| SECONDARY | Absolute Change From Baseline in Hepatic Fat Percent | Baseline and 16 weeks of treatment | All patients treated | percent of hapatic fat | MEAN |
| SECONDARY | Absolute Change From Baseline in Forced Expiratory Volume During 1 Second (FEV1) | Baseline and 16 weeks of treatment | All patients treated | Liters | MEAN |
| SECONDARY | Absolute Change From Baseline in Carbon Monoxide Lung Diffusing Capacity (DLCO)(a Pulmonary Function Test) | Baseline and 16 weeks of treatment | All patients treated | mL CO/min/mm Hg | MEAN |
| SECONDARY | Absolute Change From Baseline in Vitamin A | Baseline and 16 weeks of treatment | All patients treated | µmol/L | MEAN |
| SECONDARY | Absolute Change From Baseline in Vitamin E | Baseline and 16 weeks of treatment | All patients treated | umol/L | MEAN |
| SECONDARY | Absolute Change From Baseline in Vitamin D | Baseline and 16 weeks of treatment | All patients treated | nmol/L | MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| LDL-C | Lomitapide Escalated | -50.94 | Standard Deviation 9.311 | percentage change in LDL-C | |
| Absolute Change From Baseline in Alanine Aminotransferase (ALT) | Lomitapide Escalated | 91.2 | Standard Deviation 85.53 | U/L | |
| Absolute Change From Baseline in Aspartate Aminotransferase (AST) | Lomitapide Escalated | 37.5 | Standard Deviation 32.51 | U/L | |
| Absolute Change From Baseline in Total Bilirubin | Lomitapide Escalated | -0.25 | Standard Deviation 0.274 | mg/dL | |
| Absolute Change From Baseline in Hepatic Fat Percent | Lomitapide Escalated | 19.3 | Standard Deviation 12.92 | percent of hapatic fat | |
| Absolute Change From Baseline in Forced Expiratory Volume During 1 Second (FEV1) | Lomitapide Escalated | 0.070 | Standard Deviation 0.2406 | Liters | |
| Absolute Change From Baseline in Carbon Monoxide Lung Diffusing Capacity (DLCO)(a Pulmonary Function Test) | Lomitapide Escalated | -3.020 | Standard Deviation 5.3246 | mL CO/min/mm Hg | |
| Absolute Change From Baseline in Vitamin A | Lomitapide Escalated | -0.35 | Standard Deviation 0.847 | µmol/L | |
| Absolute Change From Baseline in Vitamin E | Lomitapide Escalated | -94.35 | Standard Deviation 130.797 | umol/L | |
| Absolute Change From Baseline in Vitamin D | Lomitapide Escalated | -6.57 | Standard Deviation 10.712 | nmol/L |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lomitapide Escalated | 6 | |
| Overall Study | COMPLETED | Lomitapide Escalated | 6 | |
| Overall Study | NOT COMPLETED | Lomitapide Escalated | 0 |
Source ClinicalTrials.gov
Adverse events39
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Lomitapide Escalated | 5 | 6 | |
| other | Nausea | Gastrointestinal disorders | Lomitapide Escalated | 2 | 6 | |
| other | Vomiting | Gastrointestinal disorders | Lomitapide Escalated | 2 | 6 | |
| other | Dyspepsia | Gastrointestinal disorders | Lomitapide Escalated | 1 | 6 | |
| other | Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Lomitapide Escalated | 4 | 6 | |
| other | Alinine aminotransferase increased | Investigations | Lomitapide Escalated | 3 | 6 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Lomitapide Escalated | 2 | 6 | |
| other | Fatigue | General disorders | Lomitapide Escalated | 2 | 6 | |
| other | Constipation | Gastrointestinal disorders | Lomitapide Escalated | 1 | 6 | |
| other | Headache | Nervous system disorders | Lomitapide Escalated | 3 | 6 |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lomitapide Escalated | ||
| Total, other adverse events | Lomitapide Escalated | 6 | 6 |
| Total, serious adverse events | Lomitapide Escalated | 1 | 6 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 17215532 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01556906
GET https://conductscience.org/api/trials/v1/NCT01556906/events?page=2