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New treatment option for Overweight and Obesity
Official title A Phase 1/2a Study of WVE-007 in Adults Living With Overweight or Obesity
ClinicalTrials.gov ID: NCT06842186
What this study is testing
What is WVE-007?
WVE-007 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for overweight and obesity.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60. Healthy volunteers may be eligible.
You may be able to join if
- Part A
- 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...
- 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 60 years
You likely can't join if
- Part A
- History or presence of CV disease, including heart failure (New York Heart Association [NYHA] Class III or IV), myocardial infarction, angina, or...
- 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...
See the full eligibility criteria
- Part A
- 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...
- Healthy, in the opinion of the Investigator, as determined by prestudy medical history, physical examination, and clinical laboratory assessments Part B
- Male and female participants aged 18 to 60 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
- Have Pre T2D or T2D
- Part A
- 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 Exclusion Criteria: Part B
- 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 7 half-lives (whichever is longer) before the first dose of study drug, except for allowed antihypertensive medications and...
- Taking \>2 antihypertensive medications, or antihypertensive medication dose was changed in the 60 days prior to Screening.
- Taking \>1 cholesterol-lowering medication, or cholesterol-lowering medication dose was changed in the 60 days prior to Screening.
- Cohorts 1 and 2 (preT2D) only: use of any GLP-1 receptor agonists or dual incretin agonists within the 4 months prior to Screening.
- Cohorts 4 and 5 (T2D) only: use of insulin or any medication that directly stimulates pancreatic insulin within the 60 days prior to Screening, including sulfonylureas, meglitinides, GLP-1 receptor agonists, dual...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
- Chisinau, Moldova
- Bucharest, Romania
- Cluj-Napoca, Romania
- Harrow, United Kingdom
- Merthyr Tydfil, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States; Chisinau, Moldova; Bucharest, Romania; Cluj-Napoca, Romania; Harrow, United Kingdom; Merthyr Tydfil, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.