A Phase 1 Study of WVE-007 in Adults Living With Overweight or Obesity (INLIGHT)

Wave Life Sciences

Status and phase: Enrolling; Phase 1

Conditions: Obesity and Overweight

Treatments: Drug: WVE-007

Study type: Interventional

Funder types: Industry

Identifiers

NCT06842186

WVE-007-001

Details and patient eligibility

About

The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of WVE-007 when administered subcutaneously (SC) as single ascending doses in adults who are affected by overweight or obesity.

Enrollment: 136 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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)
• Healthy, in the opinion of the Investigator, as determined by prestudy medical history, physical examination, and clinical laboratory assessments

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

136 participants in 5 patient groups

Cohort 1

Experimental group

Description:

Experimental WVE-007 (Dose 1) or Placebo

Treatment:

Drug: WVE-007

Cohort 2

Experimental group

Description:

Experimental WVE-007 (Dose 2) or Placebo

Treatment:

Drug: WVE-007

Cohort 3

Experimental group

Description:

Experimental WVE-007 (Dose 3) or Placebo

Treatment:

Drug: WVE-007

Cohort 4

Experimental group

Description:

Experimental WVE-007 (Dose 4) or Placebo

Treatment:

Drug: WVE-007

Cohort 5

Experimental group

Description:

Experimental WVE-007 (Dose 5) or Placebo

Treatment:

Drug: WVE-007