WVE-007 for Obesity

(INLIGHT Trial)

Recruiting at 6 trial locations

Overseen By Clinical Operations

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Wave Life Sciences Ltd.

Must not be taking: SiRNA agents

Disqualifiers: CV disease, Thyroid disorders, Liver disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6-8 weeks

136 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and effects of a new treatment, WVE-007, for individuals with overweight or obesity. Researchers aim to determine how the body processes different doses of this treatment when administered as an injection under the skin. Suitable participants should have a Body Mass Index (BMI) between 28 and 35 and have maintained a stable weight for the past few months. The trial will compare multiple doses of WVE-007 with a placebo to identify the optimal balance of effectiveness and safety. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that WVE-007 is likely to be safe for humans?

Research shows that WVE-007, a treatment under study for obesity, appears safe. Ongoing studies report no serious side effects, indicating that participants generally tolerate the treatment well. These findings come from studies administering WVE-007 in increasing doses, and patients continue to tolerate it well. For those considering joining a trial, this information suggests that WVE-007 might be a safe option. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for obesity?

Researchers are excited about WVE-007 for obesity because it offers a fresh approach compared to existing treatments like lifestyle changes, medications such as orlistat, or surgical interventions. WVE-007 is unique because it uses a novel mechanism of action to target the underlying biological pathways associated with obesity, potentially leading to more effective weight management. Additionally, the treatment is being tested at various doses, which could allow for personalized treatment plans tailored to individual patients’ needs. This innovative approach has the potential to offer an alternative for patients who have not had success with traditional methods.

What evidence suggests that WVE-007 might be an effective treatment for obesity?

Research has shown that a single dose of WVE-007 can effectively reduce body fat. In one study, this treatment led to a 9.4% decrease in visceral fat, the fat surrounding organs, and a 4.5% reduction in total body fat. These results suggest that WVE-007 could be promising for managing obesity. The treatment targets INHBE, a molecule involved in fat storage. Early findings indicate it could help reduce body fat in individuals struggling with obesity. Participants in this trial will receive varying doses of WVE-007 or a placebo to further evaluate its effectiveness. ^{1 2 6 7 8}

Who Is on the Research Team?

Medical Director, MD

Principal Investigator

Wave Life Sciences

Are You a Good Fit for This Trial?

This trial is for adults aged 18 to 60 with a stable body mass index (BMI) of 28 to 35, who are generally healthy as determined by medical history and exams. It's not for those with thyroid disorders, recent participation in other studies, significant heart disease, or prior use of siRNA agents within the last year.

Inclusion Criteria

Healthy, in the opinion of the Investigator, as determined by prestudy medical history, physical examination, and clinical laboratory assessments

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)

I am between 18 and 60 years old.

Exclusion Criteria

I have or had a thyroid disorder.

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

I have a history or diagnosis of liver disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive single ascending doses of WVE-007 or placebo administered subcutaneously

6-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• WVE-007

Trial Overview

The study tests WVE-007 administered under the skin at increasing doses to evaluate its safety and effects on the body in adults with overweight or obesity. The focus is on how well it's tolerated and how it influences weight-related measures.

How Is the Trial Designed?

Group I: Cohort 5 Experimental Treatment 1 Intervention

Experimental WVE-007 (Dose 5) or Placebo

Group II: Cohort 4 Experimental Treatment 1 Intervention

Experimental WVE-007 (Dose 4) or Placebo

Group III: Cohort 3 Experimental Treatment 1 Intervention

Experimental WVE-007 (Dose 3) or Placebo

Group IV: Cohort 2 Experimental Treatment 1 Intervention

Experimental WVE-007 (Dose 2) or Placebo

Group V: Cohort 1 Experimental Treatment 1 Intervention

Experimental WVE-007 (Dose 1) or Placebo

Who Is Running the Clinical Trial?

Wave Life Sciences Ltd.

Lead Sponsor

Trials

14

Recruited

630+

Citations

1.

ir.wavelifesciences.com

ir.wavelifesciences.com/news-releases/news-release-details/wave-life-sciences-announces-positive-interim-data-phase-1

Single Dose Resulted in Improvement in Body ...

From baseline, a single dose of WVE-007 improved body composition and led to a 9.4% reduction in visceral fat (p=0.02), a 4.5% reduction in ...

2.

fiercebiotech.com

fiercebiotech.com/biotech/wave-structure-move-assets-clinical-ladder-biotechs-obesity-development-blitz-rolls

Wave, Structure stocks double on obesity data readouts

In the trial, the single dose of WVE-007 helped patients reduce their visceral fat by 9.4% and achieve a 4.5% reduction in total body fat, or ...

3.

statnews.com

statnews.com/2025/12/11/wave-obesity-drug-wve-007-wall-street-body-composition/

Wave's 'gym bro' obesity drug is story over substance | STAT

In the study, WVE-007 reduced visceral fat (that's fat around your organs) by 9% compared to a placebo. That sounds like a lot, but it actually ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06842186

NCT06842186 | A Phase 1 Study of WVE-007 in Adults ...

The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of WVE-007 when administered subcutaneously (SC) as ...

5.

bioworld.com

bioworld.com/articles/726865-wave-life-structure-and-ascletis-post-wins-in-obesity-management

Wave Life, Structure and Ascletis post wins in obesity ...

The Inlight study of WVE-007, an INHBE-targeting siRNA for obesity, one 240-mg dose led to drops in total and visceral fat mass at three months ...

6.

trialfinder.panfoundation.org

trialfinder.panfoundation.org/en-US/trial/listing/578735

A Phase 1 Study of WVE-007 in Adults Living With ...

The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of WVE-007 when administered subcutaneously (SC) as ...

7.

clinicaltrialsarena.com

clinicaltrialsarena.com/news/wave-life-sciences-obesity-sirna-shows-once-or-twice-yearly-potential/

Wave Life Sciences' obesity siRNA shows “once or twice ...

While advancing dose-escalation, there have been no reported serious adverse events, with WVE-007 appearing to be safe and well tolerated to ...

8.

ir.wavelifesciences.com

ir.wavelifesciences.com/news-releases/news-release-details/wave-life-sciences-announce-interim-data-phase-1-inlight-trial

Reimagining RNA medicine

Wave Life Sciences to Announce Interim Data from the Phase 1 INLIGHT Trial of WVE-007 (INHBE) for Obesity on Monday, December 8, 2025.