Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 2 study that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 16 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04159415
The ClinicalTrials.gov registry entry for NCT04159415 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Regeneron Pharmaceuticals, which has 280 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04159415 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.