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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Wave Life Sciences USA, Inc.
Study ID
NCT06842186
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • WVE-007 — DRUG
    Stereopure siRNA oligonucleotide

Study Details

The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of ascending doses of WVE-007 when administered subcutaneously (SC) . Part A is a single ascending dose study in adults living with overweight and obesity. The Part B of the study is a repeat dose administration in two adult populations: Pre Type 2 diabetes (Pre T2D) and Type 2 Diabetes (T2D) in adults who are affected by obesity.

Key Dates

Start date
Jan 31, 2025
Status verified
Nov 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
296 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    Part A: Experimental WVE-007 (Dose 1) or Placebo Part B Pre-T2D: Experimental WVE-007 (Dose 1) or Placebo
  • Experimental: Cohort 2
    Part A: Experimental WVE-007 (Dose 2) or Placebo Part B Pre-T2D: Experimental WVE-007 (Dose 2) or Placebo
  • Experimental: Cohort 3
    Part A: Experimental WVE-007 (Dose 3) or Placebo
  • Experimental: Cohort 4
    Part A: Experimental WVE-007 (Dose 4) or Placebo Part B T2D: Experimental WVE-007 (Dose 4) or Placebo
  • Experimental: Cohort 5
    Part A: Experimental WVE-007 (Dose 5) or Placebo Part B T2D: Experimental WVE-007 (Dose 5) or Placebo

Primary Outcome Measure

The proportion of participants with adverse events [ Time Frame: Day 1 through end of study ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Parexel International-EPCU BaltimoreBaltimoreMaryland21225
Ronald Goldwater, M.D.
[email protected]
877-617-8839

Find similar trials in Baltimore, MD

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Parexel International-EPCU Baltimore· Baltimore, MD

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