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INLIGHTNCT06842186

A Phase 1/2a Study of WVE-007 in Adults Living With Overweight or Obesity

StatusRecruiting
PhasePhase 1/2
Primary completion (estimated)

At risk: Primary endpoint(s) modified.

See at-risk trials from Wave Life Sciences USA, Inc.

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Record History

All 6 versions: 6 with changes below. See every version on ClinicalTrials.gov ↗

  1. Primary endpoint(s) modified Show 4 more changesShow less
    • Enrollment increased: 296 → 400 participants
    • Trial arms changed: 5 → 7
    • Study sites: 6 to 7
    • Eligibility criteria expanded, about 58 words
  2. Primary and study completion pushed from Oct 2026 to Dec 2027v5 Show 6 more changesShow less
    • Phase changed: Phase 1 → Phase 1/2
    • Sponsor changed: Wave Life Sciences Ltd. to Wave Life Sciences USA, Inc.
    • Enrollment increased: 136 → 296 participants
    • Eligibility criteria expanded, about 253 words
    • Secondary endpoints: details revised at 3 of 3 entries
    • Study title revised
  3. Site contacts updated at 1 of 6 sitesv4
  4. Study sites: 5 to 6v3
  5. Study sites: 1 to 5v2
  6. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

The proportion of participants with treatment emergent adverse events
Timeframe: Day 1 through end of study

Secondary (3)

Maximum concentration of WVE-007 in plasma (Cmax)
Area under the plasma concentration time curve for WVE-007 from time 0 to last measurable concentration (AUClast)
Change over time from baseline levels of serum activin E

Arms and interventions

Cohort 1Experimental

Part A: Experimental WVE-007 (Dose 1) or Placebo Part B non-T2D: Experimental WVE-007 (Dose 1) or Placebo

Cohort 2Experimental

Part A: Experimental WVE-007 (Dose 2) or Placebo Part B non-T2D: Experimental WVE-007 (Dose 2) or Placebo

Cohort 3Experimental

Part A: Experimental WVE-007 (Dose 3) or Placebo

Cohort 4Experimental

Part A: Experimental WVE-007 (Dose 4) or Placebo Part B T2D: Experimental WVE-007 (Dose 4) or Placebo

Cohort 5Experimental

Part A: Experimental WVE-007 (Dose 5) or Placebo Part B T2D: Experimental WVE-007 (Dose 5) or Placebo

Cohort 6Experimental

Part B T2D: Experimental WVE-007 (Dose 6) or Placebo with weekly tirzepatide

Cohort 7Experimental

Part B T2D: Experimental WVE-007 (Dose 7) or Placebo with weekly tirzepatide

Drugs: WVE-007

Sites

7 sites in 4 countries

Romania 2, United Kingdom 2, United States 2, Moldova 1