Clinical Trial

A First-in-human, 3-part Study of MRT-8102 in Healthy Participants and Participants at Cardiovascular Risk With Elevated CRP

Active, Not Recruiting Phase 1
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Record status
This record was last updated June 4, 2026 (before its estimated July 2026 completion). Its status may not reflect the trial's current state.
Summary
The principal aim of this study is to obtain safety and tolerability data when MRT-8102 is administered orally as single and multiple doses to healthy participants and participants at cardiovascular risk with elevated CRP. This information, together with the pharmacokinetic (PK) data, will help establish the dose and dosing regimen suitable for future studies. The study drug, MRT-8102, is experimental. This is the first study in which MRT-8102 will be given to humans. Part 1: Healthy participants will receive a single oral dose of MRT-8102 or placebo on Day 1 Part 2: Healthy participants will receive multiple oral doses of MRT-8102 or placebo for 7 consecutive days Part 3: Participants at cardiovascular risk with elevated CRP will receive multiple oral doses of MRT-8102 or placebo for 28 consecutive days
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-08-05; most recent amendment 2026-06-03.
Status change: Recruiting → Active, Not Recruiting 2026-06-03
Trial Details
NCT Number NCT07119125
Lead Sponsor Monte Rosa Therapeutics, Inc
Conditions Healthy Volunteers, Elevated CRP
Enrollment 100 participants
Start Date 2025-06-27
Primary Completion 2026-07 (estimated)
Study Completion 2026-07 (estimated)
Updated on ClinicalTrials.gov 2026-06-04