Trial Profile

A proof-of-concept Phase 2 study for LPCN 2401 and in female population.

Status: Planning

Phase of Trial: Phase II

Latest Information Update: 14 May 2025

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At a glance

08 May 2025 According to Lipocine Media release, based on a pre-IND meeting and 2025 FDA draft guidance on Obesity and Overweight, the FDA recommends identifying the appropriate patient population for treatment, and also recommends that an approvable endpoint would be one that measures how a patient feels, functions, or survives. Therefore, in an upcoming proof-of-concept study of LPCN 2401 as an adjunct to GLP-1 agonist, Lipocine plans to target the elderly patient population,
12 Nov 2024 New trial record
07 Nov 2024 According to Lipocine Media release, company plans to meet with the FDA to discuss the study design for a proof-of-concept Phase 2 study for LPCN 2401 and expansion to the female population.

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