Actively Recruiting
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
Led by Wave Life Sciences USA, Inc. · Updated on 2026-06-02
296
Participants Needed
6
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of increasing doses of WVE-007, a stereopure siRNA oligonucleotide, in adults living with overweight or obesity. The study includes two parts: Part A focuses on single ascending doses in adults with overweight or obesity, and Part B involves repeated doses in two groups of adults with obesity who have pre-Type 2 diabetes or Type 2 diabetes. This Phase 1/2a study is randomized, double-blind, and placebo-controlled to carefully assess the investigational treatment.
CONDITIONS
Brief Title
A Phase 1/2a Study of WVE-007 in Adults Living With Overweight or Obesity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female participants aged 18 to 60 years
- For Part A: BMI 28 to 35 kg/m2 stable for 3 to 6 months; BMI 28 to 40 kg/m2 allowed for cohort expansion
- For Part B: BMI 35 to 50 kg/m2 inclusive
- Healthy as determined by medical history, physical exam, and lab tests
- For Part B: Thyroid stimulating hormone within normal range; may be on stable supplemental thyroid hormone
- For Part B: Diagnosed with pre-Type 2 diabetes or Type 2 diabetes
You will not qualify if you...
- History or presence of cardiovascular disease including heart failure (NYHA Class III or IV), myocardial infarction, or angina
- History or presence of thyroid disorders
- Medical history or diagnosis of liver disease causes
- Use of any siRNA agent within the prior 12 months
- Receipt of investigational agents within 90 days or 5 half-lives before first dose or follow-up from another trial
- For Part B: Use of prescription medications like anti-obesity or psychiatric drugs within 14 days before first dose, except allowed antihypertensives and statins
- For Part B: Taking more than 2 antihypertensive medications or recent dose changes
- For Part B: Taking more than 1 cholesterol-lowering medication or recent dose changes
- For Part B pre-T2D cohorts: Use of GLP-1 receptor agonists or dual incretin agonists within 4 months before screening
- For Part B T2D cohorts: Use of insulin or medications stimulating insulin within 60 days before screening including sulfonylureas, meglitinides, GLP-1 receptor agonists, dual incretin agonists, and DPP-4 inhibitors
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 169 days in Part A; up to 253 days in Part B
Participants receive ascending doses of the study drug WVE-007 or placebo to evaluate safety, tolerability, and pharmacokinetics.
Multiple visits throughout treatment period
Trial Site Locations
Total: 6 locations
1
Parexel International-EPCU Baltimore
Baltimore, Maryland, United States, 21225
Actively Recruiting
2
ARENSIA Research Clinic
Chisinau, Moldova, MD-2025
Actively Recruiting
3
Arensia Clinics S.R.L.
Bucharest, Romania, 011658
Actively Recruiting
4
Spitalul Clinic Judetean De Urgenta Cluj
Cluj-Napoca, Romania, 400006
Actively Recruiting
5
Parexel International Early Phase Clinical Unit
Harrow, United Kingdom, HA1 3UJ
Actively Recruiting
6
Simbec-Orion Clinical Pharmacology
Merthyr Tydfil, United Kingdom, CF48 4DR
Actively Recruiting
Research Team
C
Clinical Operations
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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