RecruitingPhase 1NCT06842186

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

A Phase 1, Randomized, Double-blind, Placebo-controlled Study of Ascending Doses of WVE-007 to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Adults Living With Overweight or Obesity


Sponsor

Wave Life Sciences Ltd.

Enrollment

136 participants

Start Date

Jan 31, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 60 Years

Inclusion Criteria3

  • 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 Criteria5

  • 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

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Interventions

DRUGWVE-007

Stereopure siRNA oligonucleotide


Locations(6)

Parexel International-EPCU Baltimore

Baltimore, Maryland, United States

ARENSIA Research Clinic

Chisinau, Moldova

Arensia Clinics S.R.L.

Bucharest, Romania

Spitalul Clinic Judetean De Urgenta Cluj

Cluj-Napoca, Romania

Parexel International Early Phase Clinical Unit

Harrow, United Kingdom

Simbec-Orion Clinical Pharmacology

Merthyr Tydfil, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06842186


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