Trial Profile

A first-in-human (FIH) study of RJVA-001 in Type 2 Diabetes (T2D)

Status: Recruiting

Phase of Trial: Phase I/II

Latest Information Update: 12 Jan 2026

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At a glance

05 Jan 2026 According to a Fractyl Health media release, company expects topline 6-month REMAIN-1 Pivotal data and a potential Revita PMA filing in post-GLP-1 weight maintenance in H2 2026.
05 Jan 2026 According to a Fractyl Health media release, company expects 6-month REMAIN-1 Midpoint data in late January 2026, completion of REMAIN-1 Pivotal randomizations in early 2026, 1-year REVEAL-1 data in Q2, and 1-year REMAIN-1 Midpoint data in Q3 2026.
05 Jan 2026 According to a Fractyl Health media release, company expects regulatory feedback on the RJVA-001 CTA in Q2 2026, with first-in-human dosing and preliminary data anticipated in H2 2026, pending CTA authorization.

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