Study of REGN4461, a Leptin Receptor Agonist Antibody, in Patients With Generalized Lipodystrophy
Status:
Recruiting
Trial end date:
2023-06-14
Target enrollment:
Participant gender:
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 2 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.