Recruiting
Phase 1
Phase 2

WVE-007

Sponsor:

Wave Life Sciences USA, Inc.

Code:

NCT06842186

Conditions

Overweight and Obesity

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

Interventions

WVE-007

Study Details

Brief summary:

The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of ascending doses of WVE-007 when administered subcutaneously (SC) . Part A is a single ascending dose study in adults living with overweight and obesity. The Part B of the study is a repeat dose administration in two adult populations: Pre Type 2 diabetes (Pre T2D) and Type 2 Diabetes (T2D) in adults who are affected by obesity.

Conditions

Overweight and Obesity

Study ID

NCT06842186

Start date

Jan 31, 2025

Status verified date

Nov, 2025

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

Inclusion Criteria: Part A

  • 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). For participants considered for enrollment in a cohort expansion, BMI 28 to 40 kg/ m2 will be allowed.
  • Healthy, in the opinion of the Investigator, as determined by prestudy medical history, physical examination, and clinical laboratory assessments

Inclusion Criteria : Part B

  • Male and female participants aged 18 to 60 years
  • BMI 35 to 50 kg/m2 (inclusive)
  • Thyroid stimulating hormone is within normal range at Screening. May be on supplemental thyroid hormone as managed by their prescribing physician and stable within the last 60 days
  • Have Pre T2D or T2D

Exclusion Criteria: Part A

  • 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

Exclusion Criteria: Part B

  • History of significant CV disease in the opinion of the Investigator.
  • Use of prescription medications (ie, anti-obesity or psychiatric medications) within 14 days or 7 half-lives (whichever is longer) before the first dose of study drug, except for allowed antihypertensive medications and statins.
  • Taking >2 antihypertensive medications, or antihypertensive medication dose was changed in the 60 days prior to Screening.
  • Taking >1 cholesterol-lowering medication, or cholesterol-lowering medication dose was changed in the 60 days prior to Screening.
  • Cohorts 1 and 2 (preT2D) only: use of any GLP-1 receptor agonists or dual incretin agonists within the 4 months prior to Screening.
  • Cohorts 4 and 5 (T2D) only: use of insulin or any medication that directly stimulates pancreatic insulin within the 60 days prior to Screening, including sulfonylureas, meglitinides, GLP-1 receptor agonists, dual incretin agonists, and DPP-4 inhibitors.
  • 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

Enrollment

296 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort 1

Part A: Experimental WVE-007 (Dose 1) or Placebo Part B Pre-T2D: Experimental WVE-007 (Dose 1) or Placebo

experimental: Cohort 2

Part A: Experimental WVE-007 (Dose 2) or Placebo Part B Pre-T2D: Experimental WVE-007 (Dose 2) or Placebo

experimental: Cohort 3

Part A: Experimental WVE-007 (Dose 3) or Placebo

experimental: Cohort 4

Part A: Experimental WVE-007 (Dose 4) or Placebo Part B T2D: Experimental WVE-007 (Dose 4) or Placebo

experimental: Cohort 5

Part A: Experimental WVE-007 (Dose 5) or Placebo Part B T2D: Experimental WVE-007 (Dose 5) or Placebo

Interventions

WVE-007

Stereopure siRNA oligonucleotide

Primary outcome measure

  • The proportion of participants with adverse events [ Time Frame: Day 1 through end of study ]

Central Contacts and Locations

Central contacts

Clinical Operations

855-215-4687Clinicaltrials@wavelifesci.com

Locations

Parexel International-EPCU Baltimore

Recruiting

Baltimore, Maryland, United States, 21225

Contacts

Ronald Goldwater, M.D.

877-617-8839study.baltimore@parexel.com

More Information

Sponsor

Wave Life Sciences USA, Inc.

Last update posted

Jun 2, 2026

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-25. This information was provided to ClinicalTrials.gov by Wave Life Sciences USA, Inc. on 2026-06-02. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.