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, is evaluating the safety & tolerability of a new drug, WVE-007, in adults 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 & 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 has been designed to lower levels of a protein, Activin E, which is produced in the liver. This may help increase fat breakdown and lead to weight loss while preserving muscle mass. The study tests different single (Part A) & multiple (Part B) doses of WVE-007 given by injection under the skin. Potential benefits include possible fat loss, weight loss & improved metabolic health (ie reduction of risk for type 2 diabetes [T2D] & heart disease). Participants may have side effects related to liver or kidneys, to the WVE-007 or placebo injection such as redness, swelling, itching, or pain at injection site, or additional side effects that are not yet known.
Adults aged 18-60 with a body mass index (BMI, a measure of height related to body weight) of 28-35 kg/m2 (Part A; base group), 28-40 kg/m2 (Part A; expansion group) or 35-50 kg/m2 (Part B) may be eligible to participate. Part B will be administered in 2 populations (T2D & pre-T2D). The study will take place at a minimum of 4 study sites in ≥3 countries.
Part A: up to 136 participants may be enrolled for at least 28 wks each. Part B: up to 240 participants may be enrolled for about 52 wks each. Participants will be randomly assigned to receive either WVE-007 or placebo (containing no active drug) & will undergo various tests & assessments, including blood sampling, physical exams, ECGs (tests to check heartbeat) & 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