A Phase 1 Study of WVE-007 in Adults Living with Overweight or Obesity
Research type
Research Study
Full title
A Phase 1, 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
IRAS ID
1011196
Contact name
Clinical Operations
Contact email
Sponsor organisation
Wave Life Sciences UK Limited
Clinicaltrials.gov Identifier
Research summary
This study, sponsored by Wave Life Sciences UK Limited, aims to evaluate how safe and tolerable a new drug, called WVE-007, is in adults who are living with overweight or obesity. Obesity is a major health concern affecting many people worldwide. This research study is important because obesity rates continue to rise globally, creating an urgent need for new, effective treatments to help people lose weight and reduce their risk of serious obesity-related health problems. WVE-007 represents a new approach that could potentially provide benefits beyond existing obesity medications.
WVE-007 is designed to reduce levels of a protein called activin E, which may help increase fat breakdown and lead to weight loss. The study will test different single doses of WVE-007 given by injection under the skin. Potential benefits include possible weight loss and improved metabolic health, though this is not guaranteed.
Adults aged 18-65 with a body mass index (BMI) of 28-35 kg/m2 (up to 40 kg/m2 for some participants enrolling in some treatment groups) may be eligible to participate. The study will take place at a minimum of 4 study sites in at least 3 countries.
Up to 136 participants may be enrolled for about 24 weeks each. Participants will be randomly assigned to receive either a single dose of WVE-007 or placebo and will undergo various tests and assessments, including blood sampling, physical examinations, ECGs, and body composition scans.REC name
London - Surrey Borders Research Ethics Committee
REC reference
25/LO/0004
Date of REC Opinion
11 Apr 2025
REC opinion
Further Information Favourable Opinion