NCT06842186PHASE1, PHASE2RecruitingAccepts Healthy Volunteers
A Phase 1/2a Study of WVE-007 in Adults Living With Overweight or Obesity
Wave Life Sciences USA, Inc.
Start Date
1/31/2025
Completion Date
12/1/2027
Summary
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.
Eligibility Criteria
Age Range: 18 years to 60 years
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.
Interventions
DRUG
WVE-007
Conditions
Overweight and Obesity
Locations
Parexel International-EPCU Baltimore
Baltimore, Maryland 21225
United States
ARENSIA Research Clinic
Chisinau, MD-2025
Moldova
Arensia Clinics S.R.L.
Bucharest, 011658
Romania
Spitalul Clinic Judetean De Urgenta Cluj
Cluj-Napoca, 400006
Romania
Parexel International Early Phase Clinical Unit
Harrow, HA1 3UJ
United Kingdom
Simbec-Orion Clinical Pharmacology
Merthyr Tydfil, CF48 4DR
United Kingdom