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MRT-8102

Phase 1

Healthy Volunteers | Small molecule | Other |Monte Rosa Therapeutics, Inc.|Last Updated: Jun 4, 2026

Target and mechanism

Molecular targetNEK7
Target classProtein
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment100

FDA Designations

No designations recorded

Clinical trial landscape

MRT-8102 · 1 trial · 2 indications

Phase 1 1
NCT07119125A First-in-human, 3-part Study of MRT-8102 in Healthy Participants and Participants at Cardiovascular Risk With Elevated CRPHealthy Volunteers
ACTIVE NOT_RECRUITING100 Analytics
PHASE1ACTIVE NOT_RECRUITING
A First-in-human, 3-part Study of MRT-8102 in Healthy Participants and Participants at Cardiovascular Risk With Elevated CRP
Healthy VolunteersUnlock trial analytics

Study Endpoints

Primary Endpoints

To evaluate the safety and tolerability of single doses of MRT-8102 in healthy adult participants
15 days

Incidence of treatment-emergent adverse events by type severity seriousness and relationship to treatment and changes from baseline in safety-related clinical lab parameter, vital signs 12-lead ECGs and PEs

To evaluate the safety and tolerability of multiple ascending doses of MRT-8102 in healthy adult participants.
21 days

Incidence of treatment-emergent adverse events by type severity seriousness and relationship to treatment and changes from baseline in safety-related clinical lab parameter, vital signs 12-lead ECGs and PEs

To evaluate the safety and tolerability of 28-day daily dosing of MRT-8102 in participants at cardiovascular risk with elevated CRP
56 days

Incidence of treatment-emergent adverse events by type severity seriousness and relationship to treatment and changes from baseline in safety-related clinical lab parameter, vital signs 12-lead ECGs and PEs

Secondary Endpoints

Characterize the PK Profile (peak plasma concentration) of MRT-8102 after single doses of MRT-8102 in healthy adult participants
Up to 8 days
Characterize the PK Profile (plasma concentration versus time) of MRT-8102 after single doses of MRT-8102 in healthy adult participants
Up to 8 days
Assess the effect of a high-fat/high-calorie meal on the PK (peak plasma concentration) of MRT-8102 02 in healthy adult participants
Up to 8 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1: Single Ascending Dose (MRT-8102)EXPERIMENTALSingle Dose of MRT-8102
Part 1: Single Ascending Dose (Placebo)PLACEBO_COMPARATORSingle Dose of Placebo
Part 2: Multiple Ascending Dose (MRT-8102)EXPERIMENTAL7-day Daily Dose of MRT-8102
Part 2: Multiple Ascending Dose (Placebo)PLACEBO_COMPARATOR7-day Daily Dose of Placebo
Part 3: elevated CRP (MRT-8102)EXPERIMENTAL28-day Daily Dose of MRT-8102
Part 3: elevated CRP (Placebo)PLACEBO_COMPARATOR28-day Daily Dose of Placebo

Interventions

NameTypeDescription
MRT-8102DRUGOral capsules
PlaceboDRUGOral capsules
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites4

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 methylxan...

Countries:United States
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Frequently asked questions about MRT-8102

What is MRT-8102 used for?

MRT-8102 is an investigational small molecule being studied in healthy volunteers and participants at cardiovascular risk with elevated CRP. It is currently in Phase 1 clinical development and is not approved by the FDA.

What does MRT-8102 target?

MRT-8102 targets NEK7, a protein involved in cellular processes. By targeting NEK7, the drug aims to modulate pathways relevant to inflammation and cardiovascular risk, though the exact mechanism is still under investigation in clinical trials.

Who makes MRT-8102?

MRT-8102 is being developed by Monte Rosa Therapeutics, Inc., a biopharmaceutical company traded on the stock exchange under the ticker GLUE.

What phase is MRT-8102 in?

MRT-8102 is in Phase 1 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities.

What clinical trials is MRT-8102 in?

MRT-8102 is being studied in a first-in-human, 3-part trial (NCT07119125) in healthy participants and participants at cardiovascular risk with elevated CRP. The trial is active but not recruiting, with an enrollment of 100 participants in the United States.

Is MRT-8102 the same as NEK7 inhibitor?

MRT-8102 is a small molecule that targets NEK7, making it a NEK7 inhibitor. However, it is not known by any other drug names; MRT-8102 is the sole identifier for this investigational compound.