For Healthcare Professionals

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

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About the study

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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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

  1. Diagnosis of congenital or acquired generalized lipodystrophy (GLD), as defined in the protocol
  2. Presence of one or both of the following metabolic abnormalities at screening:
  3. HbA1c ≥ 7% OR
  4. Fasting TG ≥250 mg/dL
  5. 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.
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 844-734-6643Email iconEmail Study Center

Study’s details


Contition

Generalized Lipodystrophy

Age

12+

Phase

Phase 2

Participants needed

16

Est. Completion Date

Aug 2024

Treatment type

Interventional


Sponsor

Regeneron Pharmaceuticals

ClinicalTrials.gov identifier

NCT04159415

Study number

R4461-GLD-1875

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