Tests WVE-007 injections in adults living with overweight or obesity
Tests the safety of WVE-007, given by injection, in adults with obesity.
Plain-language title generated from the registry record
Registry title: A Phase 1/2a Study of WVE-007 in Adults Living With Overweight or Obesity
Key facts
- Where
- Bucharest and Cluj-Napoca, RomaniaSee the 2 sites
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT06842186, who can take part
Where in Romania
- Arensia Clinics S.R.L.Bucharest, RomaniaTaking people
- Spitalul Clinic Judetean De Urgenta ClujCluj-Napoca, RomaniaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Wave Life Sciences USA, Inc.
- Trial code
- NCT06842186EU 2024-520203-41-00
- Record updated
- 26 October 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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). For participants considered for enrollment in a cohort expansion, BMI 28 to 40 kg/ m2 will be allowed; Healthy, in the opinion of the Investigator, as determined by prestudy medical history, physical examination, and clinical laboratory assessments; Male and female participants aged 18 to 75 years; BMI 35 to 50 kg/m2 (inclusive); Thyroid stimulating hormone is within normal range at Screening. May be on supplemental thyroid hormone as managed by their prescribing physician and stable within the last 60 days; Participants with or without Type 2 Diabetes (T2D and non-T2D, respectively).
Exclusion: 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; Taking >3 antihypertensive medications, or antihypertensive medication dose was changed in the 60 days prior to Screening; Taking >2 cholesterol-lowering medication, or cholesterol-lowering medication dose was changed in the 60 days prior to Screening; Cohorts 1 and 2 only: use of any GLP-1 receptor agonists or dual incretin agonists within the 4 months prior to Screening; Cohorts 4 to 7 only: use of sulfonylurea and meglitinides within 60 days prior to Screening and insulin, GLP-1 receptor agonist, and dual incretin agonist within 90 days prior to Screening; 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; History or presence of thyroid disorders; Medical history or diagnosis of causes of liver disease; History of significant CV disease in the opinion of the Investigator; Use of prescription medications (ie, anti-obesity or psychiatric medications) within 14 days or 5 half-lives (whichever is longer) before the first dose of study drug, except for allowed antihypertensive medications and lipid lowering medications; Cohorts 6 and 7 only: Known serious hypersensitivity to tirzepatide or any excipients; Diagnosis of Type 1 diabetes mellitus, or dependence on daily or ongoing use of insulin or insulin analogs for glycemic control; 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.