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NCT01258907 · ClinicalTrials.gov registry record · Phase 2

A Study to Evaluate the Safety, Tolerability, and Activity of Intravenous MLDL1278A in Patients on Standard-of-Care Therapy for Stable Atherosclerotic Cardiovascular Disease (GLACIER)

A Phase 2 study, sponsored by Genentech.

Completed
Registry status
Phase 2
Development phase
147
Enrollment target

NCT01258907: Completed Phase 2 study, sponsored by Genentech.

NCT01258907 is a Phase 2 study that has completed, run by Genentech. The registered enrollment target is 147 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (11% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01258907, a Phase 2 study, has completed, sponsored by Genentech.

COMPLETED
Registry status
Phase 2
Development phase
147 participants
Enrollment target

Study Summary

This is a Phase II (proof-of-activity), double-blind, placebo-controlled, randomized, multicenter study of MLDL1278A (also known as BI-204) involving patients on standard-of-care therapy for atherosclerotic cardiovascular disease with evidence of vascular inflammation, as quantified by FDG-PET/CT.

Interventions

  • DRUG placebo
  • DRUG MLDL1278A
  • DRUG statin, stable dose

Trial Details

FieldValue
Enrollment Target 147 participants
Start Date 2010-03
Phase Phase 2
Genentech

332 total trials

What the finished NCT01258907 record still lists

NCT01258907 is an interventional study that assigns participants to a tested intervention. The registered 147 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (11% higher).

The record links to 0 conditions, and to 3 interventions - of which placebo is the first listed.

NCT01258907 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01258907 about?

NCT01258907 is a clinical study titled "A Study to Evaluate the Safety, Tolerability, and Activity of Intravenous MLDL1278A in Patients on Standard-of-Care Therapy for Stable Atherosclerotic Cardiovascular Disease (GLACIER)". This is a Phase II (proof-of-activity), double-blind, placebo-controlled, randomized, multicenter study of MLDL1278A (also known as BI-204) involving patients on standard-of-care therapy for atherosclerotic cardiovascular disease with evidence of vascular inflammation, as quantified by FDG-PET/CT.

What is the current status of trial NCT01258907?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 147 participants. The study started on 2010-03.

What interventions are being tested in trial NCT01258907?

The interventions under investigation include: placebo (DRUG), MLDL1278A (DRUG), statin, stable dose (DRUG).

Who is sponsoring clinical trial NCT01258907?

This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01258907's enrollment target sits among peer trials

147 495th of 2000 higher than 1,505 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 NCT01258907, the US trial registry maintained by the National Library of Medicine. NCT01258907 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.