NCT06842186

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P75+ for phase_1

Timeline
5mo left

Started Jan 2025

Geographic Reach
4 countries

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress76%
Jan 2025Oct 2026

First Submitted

Initial submission to the registry

January 29, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

January 31, 2025

Completed
24 days until next milestone

First Posted

Study publicly available on registry

February 24, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

February 10, 2026

Status Verified

November 1, 2025

Enrollment Period

1.7 years

First QC Date

January 29, 2025

Last Update Submit

February 6, 2026

Conditions

Obesity and Overweight

Outcome Measures

Primary Outcomes (1)

  • The proportion of participants with adverse events

    Day 1 through end of study

Secondary Outcomes (3)

  • 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

Other Outcomes (2)

  • Percent change of weight (kg) from baseline

    Day 1 through 169

  • Body composition changes as follows: Change in body fat percentage from baseline, percent change of visceral fat (kg) from baseline, and percent change in fat-free mass (kg) from baseline

    Day 1 through 169

Study Arms (5)

Cohort 1

EXPERIMENTAL

Experimental WVE-007 (Dose 1) or Placebo

Drug: WVE-007

Cohort 2

EXPERIMENTAL

Experimental WVE-007 (Dose 2) or Placebo

Drug: WVE-007

Cohort 3

EXPERIMENTAL

Experimental WVE-007 (Dose 3) or Placebo

Drug: WVE-007

Cohort 4

EXPERIMENTAL

Experimental WVE-007 (Dose 4) or Placebo

Drug: WVE-007

Cohort 5

EXPERIMENTAL

Experimental WVE-007 (Dose 5) or Placebo

Drug: WVE-007

Interventions

WVE-007DRUG

Stereopure siRNA oligonucleotide

Cohort 1Cohort 2Cohort 3Cohort 4Cohort 5

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Parexel International-EPCU Baltimore

Baltimore, Maryland, 21225, United States

RECRUITING

ARENSIA Research Clinic

Chisinau, MD-2025, Moldova

RECRUITING

Arensia Clinics S.R.L.

Bucharest, 011658, Romania

RECRUITING

Spitalul Clinic Judetean De Urgenta Cluj

Cluj-Napoca, 400006, Romania

RECRUITING

Parexel International Early Phase Clinical Unit

Harrow, HA1 3UJ, United Kingdom

RECRUITING

Simbec-Orion Clinical Pharmacology

Merthyr Tydfil, CF48 4DR, United Kingdom

RECRUITING

MeSH Terms

Conditions

ObesityOverweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Medical Director, MD

    Wave Life Sciences

    STUDY DIRECTOR

Central Study Contacts

Clinical Operations

CONTACT

855-215-4687Clinicaltrials@wavelifesci.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2025

First Posted

February 24, 2025

Study Start

January 31, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

February 10, 2026

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

MO(1)US(1)RO(2)GB(2)