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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

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment381

FDA Designations

No designations recorded

Clinical trial landscape

MET233 and MET097 · 1 trial · 1 indication

Phase 1 1
NCT06924320A Study of MET233 in Combination With MET097 in Individuals With Obesity or Overweight With or Without DiabetesObesity and Obesity-related Medical Conditions
RECRUITING381 Analytics
PHASE1RECRUITING
A Study of MET233 in Combination With MET097 in Individuals With Obesity or Overweight With or Without Diabetes
Obesity and Obesity-related Medical ConditionsUnlock trial analytics

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 to 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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Frequently asked questions about MET233 and MET097

What is MET233 used for?

MET233 is an investigational monoclonal antibody being developed for obesity and obesity-related medical conditions, as well as for obesity and overweight. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.

How does MET233 work?

MET233 is a monoclonal antibody, a type of biologic designed to target specific molecules in the body. However, its precise molecular target has not been disclosed in available information, so its exact mechanism of action is not publicly detailed.

Who is developing MET233?

MET233 is being developed by Metsera, Inc., a biopharmaceutical company publicly traded under the ticker symbol MTSR. The company is conducting clinical trials to evaluate the drug's safety and efficacy in individuals with obesity or overweight.

What phase is MET233 in?

MET233 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory bodies. The ongoing Phase 1 trials are designed to assess safety, tolerability, and preliminary efficacy.

What clinical trials is MET233 in?

MET233 is being studied in two Phase 1 clinical trials. One trial, NCT06924320, is recruiting and evaluates MET233 in combination with MET097 in individuals with obesity or overweight with or without diabetes. Another trial, NCT07022977, has been completed and studied MET233 alone in individuals with obesity or overweight.

Is MET233 the same as MET097?

MET233 is not the same as MET097. MET233 is a separate investigational monoclonal antibody, while MET097 is a different drug candidate. They are being studied together in a combination trial, but they are distinct therapeutic agents.