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Study to Evaluate the Effects of MBX-8025 in Patients With HoFH

NCT02472535 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2016-03-09

No results posted yet for this study

Summary

A 12-week, open-label, dose-escalating, phase 2 study to evaluate the effects of MBX-8025 in patients with Homozygous Familial Hypercholesterolemia (HoFH).

Conditions

  • Homozygous Familial Hypercholesterolemia

Interventions

OTHER

Run-In Period: Placebo

2 capsules, once a day for two weeks

DRUG

MBX-8025 50 mg (Dose Escalation Period 1)

1 capsule once a day for 4 weeks (MBX-8025 50 mg capsule)

DRUG

MBX-8025 50 mg or 100 mg (Dose Escalation Period 2)

1 capsule once a day for 4 weeks (MBX-8025 50 mg or 100 mg capsule)

DRUG

MBX-8025 50 mg, 100 mg or 200 mg (Dose Escalation Period 3)

1 or 2 capsules once a day for 4 weeks (MBX-8025 50 mg, 100 mg or two (2) 100 mg capsules)

Sponsors & Collaborators

Principal Investigators

  • Pol F Boudes, M.D. · Gilead Sciences

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2016-02-29
Completion
2016-02-29

Countries

  • Canada
  • France
  • Netherlands
  • Norway

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02472535 on ClinicalTrials.gov