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NCT05088460 · ClinicalTrials.gov registry record · Phase 2
A Study to Examine the Effects of the Leptin Receptor (LEPR) Agonist Antibody REGN4461 in Adult Patients With Familial Partial Lipodystrophy (FPLD)
A Phase 2 study, sponsored by Regeneron Pharmaceuticals.
- Terminated
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
NCT05088460 is a Phase 2 study that was terminated before completion, run by Regeneron Pharmaceuticals. The registered enrollment target is 20 participants.
The verdict
NCT05088460, a Phase 2 study, was terminated before completion, sponsored by Regeneron Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
Study Summary
Two cohorts are being studied based on leptin levels. Cohort A is composed of patients with baseline leptin \<8.0 ng/mL and Cohort B is composed of patients with baseline leptin 8.0 to ≤20.0 ng/mL The primary objectives will be evaluated for patients in Cohort A only: * To evaluate the effect of REGN4461 on fasting triglycerides (TG) in patients with elevated baseline fasting TG * To evaluate the effect of REGN4461 on hyperglycemia in patients with elevated baseline Hemoglobin A1c (HbA1c) The following secondary objectives of the study will be evaluated for Cohort B and for the combined set of Cohorts A plus B: * To evaluate the effect of REGN4461 on fasting TG levels in patients with hypertriglyceridemia * To evaluate the effect of REGN4461 on glycemic control in patients with hyperglycemia The following secondary objectives of the study will be evaluated for Cohorts A and B separately, and for the combined set of Cohorts A plus B: * To evaluate the effect of REGN4461 on liver fat in patients with hepatic steatosis * To evaluate the effect of REGN4461 on hunger * To evaluate safety and tolerability of REGN4461 * To characterize the concentration profile of REGN4461 over time * To assess immunogenicity to REGN4461
Interventions
- DRUG Matching Placebo
- DRUG REGN4461
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2022-02-28 |
| Est. Completion | 2024-04-18 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05088460
The ClinicalTrials.gov registry entry for NCT05088460 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 20 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 2 interventions - of which Matching Placebo is the first listed.
NCT05088460 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05088460 about?
NCT05088460 is a clinical study titled "A Study to Examine the Effects of the Leptin Receptor (LEPR) Agonist Antibody REGN4461 in Adult Patients With Familial Partial Lipodystrophy (FPLD)". Two cohorts are being studied based on leptin levels. Cohort A is composed of patients with baseline leptin \<8.0 ng/mL and Cohort B is composed of patients with baseline leptin 8.0 to ≤20.0 ng/mL The primary objectives will be evaluated for patients in Cohort A only: * To evaluate the effect of R...
What is the current status of trial NCT05088460?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2022-02-28. Estimated completion is 2024-04-18.
What interventions are being tested in trial NCT05088460?
The interventions under investigation include: Matching Placebo (DRUG), REGN4461 (DRUG).
Who is sponsoring clinical trial NCT05088460?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
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