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MET233 and MET097

Phase 1

Obesity and Obesity-related Medical Conditions | Small molecule | Metabolic |Metsera, Inc.|Last Updated: Jun 1, 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-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment381
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06924320A Study of MET233 in Combination With MET097 in Individuals With Obesity or Overweight With or Without DiabetesPHASE1 RECRUITING 381Mar 6, 2025Sep 15, 2026Jun 1, 20261 United States
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Study Endpoints
Primary Endpoints
Occurrence of treatment-emergent adverse events (TEAEs)
Part A (Baseline, Day 85), Part B (Baseline, Day 155), Part C (Baseline, Day 155), Part D (Baseline, Day 218), Part E (Baseline, Day 246), Part G (Baseline, Day 274)

For Part A, B, C, D, E and G

Secondary Endpoints
Area under the concentration versus time curve extrapolated to infinity (AUCinf)
Part A (Baseline, Day 85)
Area under the concentration versus time curve during the dosing interval (AUCtau)
Part B (Baseline, Day 155), Part C (Baseline, Day 155), Part D (Baseline, Day 218), Part E (Baseline, Day 246), Part G (Baseline, Day 274)
Minimum observed concentration (Cmin)
Part B (Baseline, Day 155), Part C (Baseline, Day 155), Part D (Baseline, Day 218), Part E (Baseline, Day 246), Part G (Baseline, Day 274)
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part A CohortEXPERIMENTALCohort participants will receive single co-administered ascending dose (SAD) of subcutaneous (SC) MET233 and SC MET097 or matched SC placebo.
Part B CohortEXPERIMENTALCohort Participants will receive multiple ascending dose (MAD) of co-administered SC MET233 with SC MET097 or matched SC placebo.
Part C CohortEXPERIMENTALCohort Participants will receive multiple doses of SC MET233 co-administered with SC MET097 or matched SC placebo in participants with T2DM.
Part D CohortEXPERIMENTALCohort Participants will receive multiple doses of weekly and monthly (ie, every 4 weeks \[QM\]) co-administered SC MET233 with SC MET097, or matched SC placebo in participants with obesity.
Part E CohortEXPERIMENTALCohort Participants will receive multiple dose QW-to-QM of SC MET233 co-administered with SC MET097 or matched SC placebo in participants with obesity.
Part G CohortEXPERIMENTALCohort Participants will receive multiple dose cohort of QW and QM SC MET097 monotherapy or matched SC placebo in participants with obesity or overweight.
Interventions
NameTypeDescription
MET233 and MET097DRUGFor subcutaneous administration
PlaceboOTHERSterile 0.9% (w/v) saline for subcutaneous administration.
MET097DRUGFor subcutaneous administration
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Adult males or females aged 18 to 75 years (inclusive) at the time of screening. * BMI ≥27.0 kg/m2 and ≤38.0 kg/m2 (inclusive) at Screening for Parts A, B, and C, and ≥30.0 kg/m2 and ≤45.0 kg/m2 (inclusive) at Screening for Parts D and E. Have a BMI ≥27.0 kg/m2 and ≤45.0 kg/m2...

Countries:United States
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Recent Changes (Last 90 Days)
MEDIUMJun 2, 2026NCT06924320Enrollment: 132 → 381
MEDIUMJun 2, 2026NCT06924320Enrollment: 132 → 381
MEDIUMJun 2, 2026NCT06924320Enrollment: 132 → 381
LOWMay 26, 2026NCT06924320primaryCompletionDate: changed
LOWMay 24, 2026NCT06924320studyFirstPostDate: changed