MRT-8102 for Inflammation

Recruiting at 3 trial locations

Overseen By Monte Rosa Therapeutics Inc. Sponsor

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Monte Rosa Therapeutics, Inc

Must not be taking: Immunomodulators

Disqualifiers: TB, HIV, Hepatitis, others

Compensation: Varies

Number of Visits: 36

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and tolerability of a new oral drug, MRT-8102, which may help reduce inflammation. The study examines how healthy individuals and those at higher risk of heart problems, indicated by elevated CRP (a blood protein signaling inflammation), respond to the drug. Participants may receive either a single dose or multiple doses over several days. Non-smokers who can avoid caffeine meet the eligibility criteria, particularly if they have cardiovascular risk factors with high CRP. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot be on other immunomodulators (drugs that affect the immune system). It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that MRT-8102 is likely to be safe for humans?

Research has shown that MRT-8102 is very safe in early lab studies. It can be administered at doses more than 200 times higher than the expected effective dose in humans without causing harm. This suggests MRT-8102 is likely safe for initial human trials. However, since this marks the first human testing of MRT-8102, the study will closely monitor for any unexpected side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about MRT-8102 because it offers a novel approach to managing inflammation. Unlike traditional treatments that often target symptoms broadly, MRT-8102 is designed to act directly on the inflammation process itself, potentially providing more precise and effective relief. While standard treatments like NSAIDs (nonsteroidal anti-inflammatory drugs) and corticosteroids can come with significant side effects and long-term risks, MRT-8102 aims to minimize these by focusing on a specific mechanism within the inflammatory pathway. This targeted action might also mean quicker results, offering hope for faster symptom relief compared to existing options.

What evidence suggests that MRT-8102 might be an effective treatment for inflammation?

Research shows that MRT-8102 targets a protein called NEK7, which belongs to a group that causes inflammation in the body. By breaking down NEK7, MRT-8102 aims to reduce inflammation. Although this is the first human trial for MRT-8102, it may help treat inflammatory conditions. The trial includes various arms, with participants receiving either MRT-8102 or a placebo, to evaluate its effect on CRP, a marker of inflammation. This could be promising for people with heart health risks. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for healthy individuals and those at cardiovascular risk with high CRP levels. Participants will be given MRT-8102, an experimental drug, or a placebo to assess safety and determine proper dosing.

Inclusion Criteria

No ECG finding of clinical significance

Abstain from caffeine- and methylxanthine-containing beverages or food

Elevated CRP value ≥3.0 mg/L at the time of screening

Exclusion Criteria

I have been exposed to or have had tuberculosis.

Pregnant, breastfeeding, or planning a pregnancy or fathering a child during the study or within 3 months after the last study drug administration

Participation in another clinical study within 30 days or within 5 half-lives (if known) prior to start of study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Single Dose Treatment

Healthy participants receive a single oral dose of MRT-8102 or placebo

1 day

1 visit (in-person)

Multiple Dose Treatment (Healthy Participants)

Healthy participants receive multiple oral doses of MRT-8102 or placebo for 7 consecutive days

7 days

7 visits (in-person)

Multiple Dose Treatment (Cardiovascular Risk Participants)

Participants at cardiovascular risk with elevated CRP receive multiple oral doses of MRT-8102 or placebo for 28 consecutive days

28 days

28 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MRT-8102

Trial Overview

MRT-8102's safety and tolerability are being tested in this study. Healthy participants receive either a single dose or multiple doses over 7 days, while those at cardiovascular risk take it for 28 days.

How Is the Trial Designed?

Group I: Part 3: elevated CRP (MRT-8102) Experimental Treatment 1 Intervention

28-day Daily Dose of MRT-8102

Group II: Part 2: Multiple Ascending Dose (MRT-8102) Experimental Treatment 1 Intervention

7-day Daily Dose of MRT-8102

Group III: Part 1: Single Ascending Dose (MRT-8102) Experimental Treatment 1 Intervention

Single Dose of MRT-8102

Group IV: Part 2: Multiple Ascending Dose (Placebo) Placebo Group 1 Intervention

7-day Daily Dose of Placebo

Group V: Part 3: elevated CRP (Placebo) Placebo Group 1 Intervention

28-day Daily Dose of Placebo

Group VI: Part 1: Single Ascending Dose (Placebo) Placebo Group 1 Intervention

Single Dose of Placebo

Who Is Running the Clinical Trial?

Monte Rosa Therapeutics, Inc

Lead Sponsor

Trials

2

Recruited

250+

Citations

1.

ir.monterosatx.com

ir.monterosatx.com/news-releases/news-release-details/monte-rosa-therapeutics-announces-first-subjects-dosed-phase-1

Release Details

Initial results from the Phase 1 study are expected in H1 2026. “The initiation of the MRT-8102 Phase 1 study represents another exciting step ...

2.

clinicaltrialsarena.com

clinicaltrialsarena.com/news/monte-rosa-mrt-8102/

Monte Rosa doses first subjects in trial of MRT-8102

This segment of the trial aims to assess the tolerability and safety of MRT-8102, as well as its impact on CRP levels, PK and other inflammatory ...

3.

seekingalpha.com

seekingalpha.com/article/4823999-monte-rosa-1st-half-2026-nek7-protein-degrader-mrt-8102-data-could-be-added-poc

Monte Rosa: H1 2026 NEK7 Protein Degrader MRT-8102 ...

GLUE advances MRT-8102, a NEK7 molecular glue degrader, into Phase 1 trials targeting inflammatory and cardio-immunology disorders, with key ...

4.

nasdaq.com

nasdaq.com/articles/monte-rosa-therapeutics-begins-phase-1-study-mrt-8102-inflammatory-conditions-initial

Monte Rosa Therapeutics Begins Phase 1 Study of MRT ...

Monte Rosa Therapeutics initiates Phase 1 study for MRT-8102, targeting inflammatory conditions; results expected in H1 2026.

5.

synapse.patsnap.com

synapse.patsnap.com/article/monte-rosa-begins-phase-1-study-of-mrt-8102-for-inflammatory-diseases

Monte Rosa Begins Phase 1 Study of MRT-8102 for ...

This innovative treatment targets NEK7, a key protein linked to the NLRP3 inflammasome, and is being developed for inflammatory conditions ...

6.

ir.monterosatx.com

ir.monterosatx.com/news-releases/news-release-details/monte-rosa-therapeutics-presents-preclinical-data-aha-scientific

Release Details

MRT-8102 has demonstrated a considerable safety margin (>200-fold exposure margin over projected human efficacious dose) in GLP toxicology ...

7.

clinicaltrialvanguard.com

clinicaltrialvanguard.com/news/nek7-degrader-mrt-8102-shows-promise-in-preclinical-data/

NEK7 Degrader MRT-8102 Shows Promise in Preclinical ...

Preclinical data presented at AHA 2025 show MRT-8102, an oral NEK7-directed molecular glue degrader, selectively degrades NEK7, ...

8.

bioworld.com

bioworld.com/articles/721054-monte-rosas-molecular-glue-degrader-mrt-8102-gains-ind-clearance-for-inflammatory-conditions

Monte Rosa's molecular glue degrader MRT-8102 gains ...

Preclinical GLP toxicology studies suggest a considerable safety margin for MRT-8102, with a greater than 200-fold exposure margin over the ...

9.

synapse.patsnap.com

synapse.patsnap.com/drug/2ec8ef8b02f64ecb970f96184b7fa6a2

MRT-8102 - Drug Targets, Indications, Patents

MRT-8102 has demonstrated a considerable safety margin (>200-fold exposure margin over projected human efficacious dose) in GLP toxicology studies. About MRT ...