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

Key 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
3. 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

Key Exclusion Criteria:

1. Treatment with metreleptin within 1 month of the screening visit
2. Treatment with over-the-counter or prescription medications for weight loss within 3 months prior to the screening visit
3. 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
4. History of Human Immunodeficiency Virus (HIV) or HIV seropositivity at screening visit
5. Uncontrolled infection with hepatitis B or hepatitis C infection, or known active tuberculosis at screening
6. 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.
7. Pregnant or breast-feeding women

NOTE: Other protocol defined inclusion/exclusion criteria apply.