Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:14 AM
Ignite Modification Date:
2025-12-25 @ 2:14 AM
NCT ID:
NCT05088460
Brief Summary:
Two cohorts are being studied based on leptin levels. Cohort A is composed of patients with baseline leptin \<8.0 ng/mL and Cohort B is composed of patients with baseline leptin 8.0 to ≤20.0 ng/mL
The primary objectives will be evaluated for patients in Cohort A only:
* To evaluate the effect of REGN4461 on fasting triglycerides (TG) in patients with elevated baseline fasting TG
* To evaluate the effect of REGN4461 on hyperglycemia in patients with elevated baseline Hemoglobin A1c (HbA1c)
The following secondary objectives of the study will be evaluated for Cohort B and for the combined set of Cohorts A plus B:
* To evaluate the effect of REGN4461 on fasting TG levels in patients with hypertriglyceridemia
* To evaluate the effect of REGN4461 on glycemic control in patients with hyperglycemia
The following secondary objectives of the study will be evaluated for Cohorts A and B separately, and for the combined set of Cohorts A plus B:
* To evaluate the effect of REGN4461 on liver fat in patients with hepatic steatosis
* To evaluate the effect of REGN4461 on hunger
* To evaluate safety and tolerability of REGN4461
* To characterize the concentration profile of REGN4461 over time
* To assess immunogenicity to REGN4461
Study:
NCT05088460
Study Brief:
Protocol Section:
NCT05088460