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NCT04026178 · ClinicalTrials.gov registry record · Phase 4
Immunogenicity of Metreleptin in Patients With Generalized Lipodystrophy
A Phase 4 study, sponsored by Aegerion Pharmaceuticals.
- Completed
- Registry status
- Phase 4
- Development phase
- 11
- Enrollment target
NCT04026178: Completed Phase 4 study, sponsored by Aegerion Pharmaceuticals.
NCT04026178 is a Phase 4 study that has completed, run by Aegerion Pharmaceuticals. The registered enrollment target is 11 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04026178, a Phase 4 study, has completed, sponsored by Aegerion Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 11 participants
- Enrollment target
Study Summary
MYALEPT™ (metreleptin) has been approved as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy (MYALEPT Prescribing Information). This study is a multicenter, open-label, Phase 4 trial to provide an assessment of the immunogenicity associated with metreleptin and of any major potential risks due to development of antibodies to metreleptin. The study is being conducted to comply with a postmarketing requirement.
Primary Outcome
Anti-metreleptin, anti-human leptin (HuL) binding antidrug antibody (ADA) titers over time. Category of in vitro cell-based neutralizing antibody (NAb) activity to metreleptin, and titer in the receptor blocking (RB) NAb assay in ADA positive samples over time.
Interventions
- DRUG Metreleptin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2018-11-14 |
| Est. Completion | 2024-10-31 |
| Phase | Phase 4 |
What the finished NCT04026178 record still lists
NCT04026178 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Metreleptin is the first listed.
NCT04026178 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04026178 about?
NCT04026178 is a clinical study titled "Immunogenicity of Metreleptin in Patients With Generalized Lipodystrophy". MYALEPT™ (metreleptin) has been approved as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy (MYALEPT Prescribing Information). This study is a multicenter, open-label, Phase 4 trial to provide...
What is the current status of trial NCT04026178?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 11 participants. The study started on 2018-11-14. Estimated completion is 2024-10-31.
What interventions are being tested in trial NCT04026178?
The interventions under investigation include: Metreleptin (DRUG).
Who is sponsoring clinical trial NCT04026178?
This trial is sponsored by Aegerion Pharmaceuticals, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04026178's enrollment target sits among peer trials
11 1931st of 2000 higher than 61 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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