Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Regeneron Pharmaceuticals
Age
12–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Study of REGN4461, a Leptin Receptor Agonist Antibody, in Patients With Generalized Lipodystrophy
