Study of REGN4461, a Leptin Receptor Agonist Antibody, in Patients With Generalized Lipodystrophy
Фаза 2
Завершено
NCT04159415
| Заболевание | Generalized Lipodystrophy |
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| Фаза | Фаза 2 |
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| Спонсор | Regeneron Pharmaceuticals |
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| Статус | Завершено |
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| Участники | 16 участн. |
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| Вмешательство | Low-Dose REGN4461, High-dose REGN4461 |
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| Дата начала | 7.01.2020 |
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| Дата завершения | 5.01.2022 |
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| Публикация результатов | 25.02.2025 |
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Кратко
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.
Absolute Change From Baseline in Participants With Elevated Baseline Hemoglobin A1c (HbA1c ≥7%) at Week 8
Baseline, Week 8 · millimoles per mole (mmol/mol)
| Treatment Sequence A, DBTP 1: Placebo SC QW | -0.1 ± 0.6 millimoles per mole (mmol/mol) |
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| Treatment Sequence B, DBTP 1: Low-dose REGN4461 SC QW | 0.2 ± 0.7 millimoles per mole (mmol/mol) |
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| Least Squares (LS) Mean Difference | 0.2 (95% CI -1.9–2.3) |
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Absolute Change From Baseline in Fasting Glucose at Week 8
Baseline, Week 8 · milligrams per deciliter (mg/dL)
| Treatment Sequence A, DBTP 1: Placebo SC QW | 15.5 ± 18.6 milligrams per deciliter (mg/dL) |
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| Treatment Sequence B, DBTP 1: Low-dose REGN4461 SC QW | 53.6 ± 19.9 milligrams per deciliter (mg/dL) |
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| LS Mean Difference | 38.1 (95% CI -21.3–97.5) |
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Absolute Change From Baseline in Weighted Mean Glucose (WMG) at Week 8
Baseline, Week 8 · mg/dL
| Treatment Sequence A, DBTP 1: Placebo SC QW | -3.7 ± 19.9 mg/dL |
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| Treatment Sequence B, DBTP 1: Low-dose REGN4461 SC QW | -3.7 ± 23.4 mg/dL |
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| Adjusted Mean Difference | 0.0 (95% CI -56.9–56.9) |
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