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New pill targets heart risk by lowering inflammation – first human trial begins

NCT ID NCT07119125

Disease control Sponsor: Monte Rosa Therapeutics, Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests an experimental drug called MRT-8102 for the first time in humans. It includes healthy volunteers and people with high inflammation (elevated CRP) who are at risk for heart problems. The goal is to check the drug's safety and find the right dose for future studies. Participants receive either the drug or a placebo by mouth for up to 28 days.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Eligibility Criteria: Inclusion Criteria (all parts) * Healthy, adult, male or females 18-65 years of age * Non-smoker who has not used nicotine- and tobacco -containing products for at least 3 months prior to start of study * Able to swallow oral medications * Abstain from caffeine- and methylxanthine-containing beverages or food Parts 3: Inclusion Criteria * Elevated CRP value ≥3.0 mg/L at the time of screening * Evidence of cardiovascular risk factors * No signs or symptoms of acute disease * No ECG finding of clinical significance Exclusion Criteria (All Parts) * History or presence of clinically significant medical or psychiatric condition or disease * Underwent surgical intervention or an operation withing 6 weeks prior to start of study * Has active TB, latent TB, a history of TB, or had close contact with a person with active TB within 8 weeks prior to the first dosing * Pregnant, breastfeeding, or planning a pregnancy or fathering a child during the study or within 3 months after the last study drug administration. * Positive urine drug or alcohol screen results * Positive results for human immunodeficiency virus (HIV), hepatitis B or Hepatitis C virus or history of resolved hepatitis * Participation in another clinical study within 30 days or within 5 half-live (if known) prior to start of study * Currently receiving other immunomodulators * History of immunodeficiency, chronic inflammatory and chronic inflammation

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Elevated CRP Healthy volunteers

Contacts and locations

Locations

  • Clinical Pharmacology of Miami, LLC

    Miami, Florida, 33172, United States

  • Endeavor Clinical Trials

    San Antonio, Texas, 78240, United States

  • ICON Clinical Research

    Lenexa, Kansas, 66219, United States

  • QPS

    Springfield, Missouri, 65807, United States

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