Clinical trial

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

Recruiting now · Phase 1, Phase 2 · 4 countries · Registry ID NCT06842186

Recruiting nowPhase 1, Phase 2Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 60 Years
SexAll
Healthy volunteersAccepted
ConditionOverweight and Obesity

Full registry 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 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.

Treatments and study arms

WVE-007

Drug

Stereopure siRNA oligonucleotide

Primary outcomes

The proportion of participants with adverse eventsDay 1 through end of study

Study locations

6 locations were listed when this page was built. The first 40 are shown.

ARENSIA Research Clinic🌐 Chisinau, Moldova
Maxim BogusContact
Arensia Clinics S.R.L.🇷🇴 Bucharest, Romania
Simona MacoveiContact
Spitalul Clinic Judetean De Urgenta Cluj🇷🇴 Cluj-Napoca, Romania
Emanuela BeniContact
Parexel International Early Phase Clinical Unit🇬🇧 Harrow, United Kingdom
Pablo ForteContact
Simbec-Orion Clinical Pharmacology🇬🇧 Merthyr Tydfil, United Kingdom
Annelize KochContact
Parexel International-EPCU Baltimore🇺🇸 Baltimore, Maryland, United States
Ronald Goldwater, M.D.Contact