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A Phase 1/2a Study of WVE-007 in Adults Living With Overweight or Obesity

RecruitingPhase 1, Phase 2Ages 18 Years - 75 YearsAllWave Life Sciences USA, Inc.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: Part A * Male and female participants aged 18 to 60 years * BMI 28 to 35 kg/m2 which has been stable (ยฑ5%) 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 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 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 5 half-lives (whichever is longer) before the first dose of study drug, except for allowed antihypertensive medications and lipid lowering medications. * 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 * 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. * 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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What it tests

  • WVE-007
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Where

7 sites
Arensia Exploratory Medicine, Inc. USA
Phoenix, United States
Parexel International-EPCU Baltimore
Baltimore, United States
ARENSIA Research Clinic
Chisinau, Moldova
Arensia Clinics S.R.L.
Bucharest, Romania
Spitalul Clinic Judetean De Urgenta Cluj
Cluj-Napoca, Romania
Parexel International Early Phase Clinical Unit
Harrow, United Kingdom
Simbec-Orion Clinical Pharmacology
Merthyr Tydfil, United Kingdom
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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