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MRT-8102

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment100
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07119125A First-in-human, 3-part Study of MRT-8102 in Healthy Participants and Participants at Cardiovascular Risk With Elevated CRPPHASE1 ACTIVE NOT_RECRUITING 100Jun 27, 2025Jul 1, 2026Jun 4, 20264 United States
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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 — 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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Recent Changes (Last 90 Days)
MEDIUMJun 4, 2026NCT07119125Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMJun 4, 2026NCT07119125Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMJun 4, 2026NCT07119125Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMJun 4, 2026NCT07119125Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWMay 26, 2026NCT07119125primaryCompletionDate: changed
LOWMay 24, 2026NCT07119125studyFirstPostDate: changed