A Phase 1 Study of WVE-007 in Adults Living with Overweight or Obesity

Phase 1

Recruiting

• Conditions: Obesity and Overweight
• Interventions: Drug: WVE-007

• Registration Number: NCT06842186
• Lead Sponsor: Wave Life Sciences Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-29
• Study Start: 2025-01-31
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-18
• Last Update Submitted: 2025-02-18
• Study First Posted: 2025-02-24
• Last Update Posted: 2025-02-24
• Primary Completion: 2026-10
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 136

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 2	WVE-007	Experimental WVE-007 (Dose 2) or Placebo
Cohort 4	WVE-007	Experimental WVE-007 (Dose 4) or Placebo
Cohort 5	WVE-007	Experimental WVE-007 (Dose 5) or Placebo
Cohort 1	WVE-007	Experimental WVE-007 (Dose 1) or Placebo
Cohort 3	WVE-007	Experimental WVE-007 (Dose 3) or Placebo

Primary Outcome Measures

Name	Time	Method
The proportion of participants with adverse events	Day 1 through end of study

Secondary Outcome Measures

Name	Time	Method
Maximum concentration of WVE-007 in plasma (Cmax)	Day 1 through 169
Area under the plasma concentration time curve for WVE-007 from time 0 to last measurable concentration (AUClast)	Day 1 through 169
Change over time from baseline levels of serum activin E	Day 1 through 169

Trial Locations

Locations (1)

ARENSIA Research Clinic; 🇲🇩 Chisinau, Moldova, Republic of