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

ConditionOverweight and Obesity

Trial statusRecruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age18-60

SponsorWave Life Sciences USA, Inc.

About this trial

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

Qualifiers

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

Male and female participants aged 18 to 60 years

Disqualifiers

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