No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 60
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
296 (estimated)
Sponsor
Wave Life Sciences USA, Inc. · Industry
Who this trial is looking for
This trial is looking for adults with overweight or obesity to test a new treatment called WVE-007. Participants will receive the treatment through a shot in the skin and will help researchers understand its safety and effect.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 18 and 60 years old.
I have a BMI between 28 and 35 kg/m2 and it has been stable.
I am in good health as decided by the study doctor.
You may not be able to join if
I have a history of heart disease or heart failure.
I have a history of thyroid problems.
I have liver disease.
I have used any siRNA agent in the last 12 months.
I have received an experimental drug in the last 90 days.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 two adult populations: Pre Type 2 diabetes (Pre T2D) and Type 2 Diabetes (T2D) in …
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 two adult populations: Pre Type 2 diabetes (Pre T2D) and Type 2 Diabetes (T2D) in adults who are affected by obesity.
Trial Locations
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Eligibility Criteria
Inclusion 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 …
Inclusion 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 will be allowed.
* Healthy, in the opinion of the Investigator, as determined by prestudy medical history, physical examination, and clinical laboratory assessments
Inclusion Criteria : 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
Exclusion Criteria: 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 statins.
* 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 incretin agonists, and DPP-4 inhibitors.
* 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.
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