Testing WVE-007 for adults with overweight or obesity
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
This study is testing a new drug called WVE-007 to see if it is safe and well-tolerated in adults who are overweight or obese.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 136 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Wave Life Sciences Ltd. Industry-sponsored |
| Locations | 6 sites (Baltimore, Maryland and 5 other locations) |
| Trial ID | NCT06842186 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and tolerability of WVE-007, administered subcutaneously in single ascending doses, in adults living with overweight or obesity. Participants will be monitored for pharmacokinetics and pharmacodynamics to understand how the drug behaves in the body. The study aims to include healthy adults aged 18 to 60 with a stable BMI between 28 and 35 kg/m2. Exclusion criteria include significant cardiovascular or thyroid conditions and recent use of investigational agents.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18 to 60 with a stable BMI between 28 and 35 kg/m2.
Not a fit: Patients with significant cardiovascular or thyroid disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for managing overweight and obesity.
How similar studies have performed: While similar approaches have been explored, this specific intervention is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male and female participants aged 18 to 60 years * BMI 28 to 35 kg/m2 which has been stable (±5%) for the previous 3 to 6 months (based on participant self-report or medical records) * Healthy, in the opinion of the Investigator, as determined by prestudy medical history, physical examination, and clinical laboratory assessments Exclusion Criteria: * History or presence of CV disease, including heart failure (New York Heart Association \[NYHA\] Class III or IV), myocardial infarction, angina, or clinically significant abnormal laboratory assessments * History or presence of thyroid disorders * Medical history or diagnosis of causes of liver disease * Use of any siRNA agent in the prior 12 months * Received an investigational agent within 90 days or 5 half-lives, whichever is longer, before the first dose of study drug or are in follow-up of another clinical study
Where this trial is running
Baltimore, Maryland and 5 other locations
- Parexel International-EPCU Baltimore — Baltimore, Maryland, United States (Recruiting)
- ARENSIA Research Clinic — Chisinau, Moldova (Recruiting)
- Arensia Clinics S.R.L. — Bucharest, Romania (Recruiting)
- Spitalul Clinic Judetean De Urgenta Cluj — Cluj-Napoca, Romania (Recruiting)
- Parexel International Early Phase Clinical Unit — Harrow, United Kingdom (Recruiting)
- Simbec-Orion Clinical Pharmacology — Merthyr Tydfil, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Clinical Operations
- Email: Clinicaltrials@wavelifesci.com
- Phone: 855-215-4687
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.