Study of REGN4461, a Leptin Receptor Agonist Antibody, in Patients With Generalized Lipodystrophy

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-07

Study Completion Date

2024-09-24

Brief Summary

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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.

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Detailed Description

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Conditions

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Generalized Lipodystrophy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Double Blind

IV infusion loading dose or SC injection QW.

Intervention Type DRUG

Other Intervention Names

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mibavademab mibavademab

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of congenital or acquired generalized lipodystrophy (GLD), as defined in the protocol
* Presence of one or both of the following metabolic abnormalities at screening:

1. HbA1c ≥ 7% OR
2. Fasting TG ≥250 mg/dL
* Generally stable diet (based on patient's recall) and medication regimen (that optimizes treatment for their metabolic disease) for at least 3 months prior to the screening visit

Exclusion Criteria

* Treatment with metreleptin within 1 month of the screening visit
* Treatment with over-the-counter or prescription medications for weight loss within 3 months prior to the screening visit
* Treatment with oral glucocorticoids \>7.5 mg prednisone equivalents per day within 3 months prior to screening visit or plans to begin treatment with oral glucocorticoids \>7.5 mg prednisone equivalents per day during the study period
* History of Human Immunodeficiency Virus (HIV) or HIV seropositivity at screening visit
* Uncontrolled infection with hepatitis B or hepatitis C infection, or known active tuberculosis at screening
* Participation in any clinical research study evaluating an Investigational product (IP) or therapy within 3 months and less than 5 half-lives of IP prior to the screening visit.
* Pregnant or breast-feeding women

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No