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WVE-007

Phase 1

Overweight and Obesity | Small molecule | Metabolic |Wave Life Sciences Ltd.|Last Updated: Jun 2, 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-BlindCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment296
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06842186A Phase 1/2a Study of WVE-007 in Adults Living With Overweight or ObesityPHASE1 RECRUITING 296Jan 31, 2025Dec 1, 2027Jun 2, 20266 United States, Moldova +2
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Study Endpoints
Primary Endpoints
The proportion of participants with adverse events
Day 1 through end of study
Secondary Endpoints
Maximum concentration of WVE-007 in plasma (Cmax)
Part A:Day 1 through 169 Part B: Day 1 through 253
Area under the plasma concentration time curve for WVE-007 from time 0 to last measurable concentration (AUClast)
Part A:Day 1 through 169 Part B: Day 1 through 253
Change over time from baseline levels of serum activin E
Part A:Day 1 through 169 Part B: Day 1 through 337
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cohort 1EXPERIMENTALPart A: Experimental WVE-007 (Dose 1) or Placebo Part B Pre-T2D: Experimental WVE-007 (Dose 1) or Placebo
Cohort 2EXPERIMENTALPart A: Experimental WVE-007 (Dose 2) or Placebo Part B Pre-T2D: Experimental WVE-007 (Dose 2) or Placebo
Cohort 3EXPERIMENTALPart A: Experimental WVE-007 (Dose 3) or Placebo
Cohort 4EXPERIMENTALPart A: Experimental WVE-007 (Dose 4) or Placebo Part B T2D: Experimental WVE-007 (Dose 4) or Placebo
Cohort 5EXPERIMENTALPart A: Experimental WVE-007 (Dose 5) or Placebo Part B T2D: Experimental WVE-007 (Dose 5) or Placebo
Interventions
NameTypeDescription
WVE-007DRUGStereopure siRNA oligonucleotide
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersYes
Study Sites6

Inclusion Criteria: Part A * Male and female participants aged 18 to 60 years * BMI 28 to 35 kg/m2 which has been stable (±5%) for the previous 3 to 6 months (based on participant self-report or medical records). For participants considered for enrollment in a cohort expansion, BMI 28 to 40 kg/ m2 ...

Countries:United StatesMoldovaRomaniaUnited Kingdom
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Recent Changes (Last 90 Days)
MEDIUMJun 2, 2026NCT06842186Enrollment: 136 → 296
MEDIUMJun 2, 2026NCT06842186Enrollment: 136 → 296
MEDIUMJun 2, 2026NCT06842186Enrollment: 136 → 296
LOWMay 26, 2026NCT06842186primaryCompletionDate: changed
LOWMay 24, 2026NCT06842186studyFirstPostDate: changed