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A Phase 1/2a Study of WVE-007 in Adults Living With Overweight or Obesity
Sponsor: Wave Life Sciences USA, Inc.
Summary
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 adult with obesity, with or without Type 2 Diabetes (T2D and non-T2D, respectively). In addition, Part B includes two dose groups that will receive WVE-007 and tirzepatide in adults living with obesity and T2D.
Official title: A Phase 1/2a, Randomized, Double-blind, Placebo-controlled Study of Ascending Doses of WVE-007 to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Adults Living With Overweight or Obesity
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
400
Start Date
2025-01-31
Completion Date
2027-12
Last Updated
2026-10-26
Healthy Volunteers
Yes
Conditions
Interventions
WVE-007
Stereopure siRNA oligonucleotide
Locations (7)
Arensia Exploratory Medicine, Inc. USA
Phoenix, Arizona, United States
Parexel International-EPCU Baltimore
Baltimore, Maryland, United States
ARENSIA Research Clinic
Chisinau, Moldova
Arensia Clinics S.R.L.
Bucharest, Romania
Spitalul Clinic Judetean De Urgenta Cluj
Cluj-Napoca, Romania
Parexel International Early Phase Clinical Unit
Harrow, United Kingdom
Simbec-Orion Clinical Pharmacology
Merthyr Tydfil, United Kingdom