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NCT06842186

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

NCT ID: NCT06842186

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-31

Study Completion Date

2026-10-31

Brief Summary

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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

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Conditions

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Obesity and Overweight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Cohort 1

Experimental WVE-007 (Dose 1) or Placebo

Group Type EXPERIMENTAL

WVE-007

Intervention Type DRUG

Stereopure siRNA oligonucleotide

Cohort 2

Experimental WVE-007 (Dose 2) or Placebo

Group Type EXPERIMENTAL

WVE-007

Intervention Type DRUG

Stereopure siRNA oligonucleotide

Cohort 3

Experimental WVE-007 (Dose 3) or Placebo

Group Type EXPERIMENTAL

WVE-007

Intervention Type DRUG

Stereopure siRNA oligonucleotide

Cohort 4

Experimental WVE-007 (Dose 4) or Placebo

Group Type EXPERIMENTAL

WVE-007

Intervention Type DRUG

Stereopure siRNA oligonucleotide

Cohort 5

Experimental WVE-007 (Dose 5) or Placebo

Group Type EXPERIMENTAL

WVE-007

Intervention Type DRUG

Stereopure siRNA oligonucleotide

Interventions

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WVE-007

Stereopure siRNA oligonucleotide

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wave Life Sciences Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director, MD

Role: STUDY_DIRECTOR

Wave Life Sciences

Locations

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Parexel International-EPCU Baltimore

Baltimore, Maryland, United States

Site Status RECRUITING

ARENSIA Research Clinic

Chisinau, , Moldova

Site Status RECRUITING

Arensia Clinics S.R.L.

Bucharest, , Romania

Site Status RECRUITING

Spitalul Clinic Judetean De Urgenta Cluj

Cluj-Napoca, , Romania

Site Status RECRUITING

Parexel International Early Phase Clinical Unit

Harrow, , United Kingdom

Site Status RECRUITING

Simbec-Orion Clinical Pharmacology

Merthyr Tydfil, , United Kingdom

Site Status RECRUITING

Countries

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United States Moldova Romania United Kingdom

Central Contacts

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Clinical Operations

Role: CONTACT

Phone: 855-215-4687

Email: [email protected]

Facility Contacts

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Ronald Goldwater, M.D.

Role: primary

Maxim Bogus

Role: primary

Simona Macovei

Role: primary

Emanuela Beni

Role: primary

Pablo Forte

Role: primary

Annelize Koch

Role: primary

Other Identifiers

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WVE-007-001

Identifier Type: -

Identifier Source: org_study_id