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NCT04159415 · ClinicalTrials.gov registry record · Phase 2
Study of REGN4461, a Leptin Receptor Agonist Antibody, in Patients With Generalized Lipodystrophy
A Phase 2 study, sponsored by Regeneron Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 16
- Enrollment target
NCT04159415: Completed Phase 2 study, sponsored by Regeneron Pharmaceuticals.
NCT04159415 is a Phase 2 study that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 16 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04159415, a Phase 2 study, has completed, sponsored by Regeneron Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 16 participants
- Enrollment target
Study Summary
The primary objectives of the study are to estimate the effects of REGN4461 on glycemic parameters in the subset of patients with elevated baseline hemoglobin A1c levels (HbA1c ≥7%) and to estimate the effects of REGN4461 on fasting triglyceride levels in the subset of patients with elevated baseline fasting triglycerides (TG ≥250 mg/dL). The secondary objectives are to estimate the effects of REGN4461 on a composite endpoint of changes in either HbA1c or fasting TG for all patients, estimate the effects of 3 dose levels of REGN4461 on glycemic parameters and fasting TG, to estimate the effects of REGN4461 on insulin sensitivity, to evaluate the safety and tolerability of REGN4461 and to evaluate the pharmacokinetics (PK) and immunogenicity of REGN4461.
Primary Outcome
Absolute change from baseline in HbA1c for subgroup of participants with baseline HbA1c ≥7% reported
Interventions
- DRUG Placebo
- DRUG Low-Dose REGN4461
- DRUG High-dose REGN4461
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2020-01-07 |
| Est. Completion | 2024-09-24 |
| Phase | Phase 2 |
What the finished NCT04159415 record still lists
NCT04159415 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04159415 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04159415 about?
NCT04159415 is a clinical study titled "Study of REGN4461, a Leptin Receptor Agonist Antibody, in Patients With Generalized Lipodystrophy". The primary objectives of the study are to estimate the effects of REGN4461 on glycemic parameters in the subset of patients with elevated baseline hemoglobin A1c levels (HbA1c ≥7%) and to estimate the effects of REGN4461 on fasting triglyceride levels in the subset of patients with elevated baselin...
What is the current status of trial NCT04159415?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 16 participants. The study started on 2020-01-07. Estimated completion is 2024-09-24.
What interventions are being tested in trial NCT04159415?
The interventions under investigation include: Placebo (DRUG), Low-Dose REGN4461 (DRUG), High-dose REGN4461 (DRUG).
Who is sponsoring clinical trial NCT04159415?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04159415's enrollment target sits among peer trials
16 1908th of 2000 higher than 82 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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