Overweight and ObesityPhase 1/2INLIGHTNCT06842186
A Phase 1/2a Study of WVE-007 in Adults Living With Overweight or Obesity
A Phase 1/2 study testing WVE-007 in people with Overweight and Obesity, run by Wave Life Sciences USA, Inc. at 7 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- WVE-007
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 7 sitesin 4 countries
- Study dates
- 31 Jan 2025to Dec 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- Male and female participants aged 18 to 75 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
- Participants with or without Type 2 Diabetes (T2D and non-T2D, respectively)
Who cannot join
- 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
- History of significant CV disease in the opinion of the Investigator.
Show all 15Show fewer
- Use of prescription medications (ie, anti-obesity or psychiatric medications) within 14 days or 5 half-lives (whichever is longer) before the first dose of study drug, except for allowed antihypertensive medications and lipid lowering medications.
- Taking >3 antihypertensive medications, or antihypertensive medication dose was changed in the 60 days prior to Screening.
- Taking >2 cholesterol-lowering medication, or cholesterol-lowering medication dose was changed in the 60 days prior to Screening.
- Cohorts 1 and 2 only: use of any GLP-1 receptor agonists or dual incretin agonists within the 4 months prior to Screening.
- Cohorts 4 to 7 only: use of sulfonylurea and meglitinides within 60 days prior to Screening and insulin, GLP-1 receptor agonist, and dual incretin agonist within 90 days prior to Screening
- Cohorts 6 and 7 only: Known serious hypersensitivity to tirzepatide or any excipients
- Diagnosis of Type 1 diabetes mellitus, or dependence on daily or ongoing use of insulin or insulin analogs for glycemic control.
- 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.
Trial locations and contacts
7 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 4 countries
United States2 sites, 1 recruiting
- Recruiting
Parexel International-EPCU Baltimore
Baltimore, Maryland, 21225
Ronald Goldwater, M.D., 877-617-8839, study.baltimore@parexel.com
- Active, not recruiting
Arensia Exploratory Medicine, Inc. USA
Phoenix, Arizona, 85015
Romania2 sites, 2 recruiting
- Recruiting
Arensia Clinics S.R.L.
Bucharest, 011658
Simona Macovei, +40711912918, simona.macovei@arensia-em.com
- Recruiting
Spitalul Clinic Judetean De Urgenta Cluj
Cluj-Napoca, 400006
Emanuela Beni, +40711912839, emanuela.beni@arensia-em.com
United Kingdom2 sites, 2 recruiting
- Recruiting
Parexel International Early Phase Clinical Unit
Harrow, HA1 3UJ
Pablo Forte, 01895 614 890, Pablo.ForteSoto@parexel.com
- Recruiting
Simbec-Orion Clinical Pharmacology
Merthyr Tydfil, CF48 4DR
Annelize Koch, 01685 700870, Annelize.koch@simbecorion.com
Moldova1 site, 1 recruiting
- Recruiting
ARENSIA Research Clinic
Chisinau, MD-2025
Maxim Bogus, 373 78883374, Maxim.bogus@arensia-em.com
About this study
Official title: A Phase 1/2a, 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
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 adult with obesity, with or without Type 2 Diabetes (T2D and non-T2D, respectively). In addition, Part B includes two dose groups that will receive WVE-007 and tirzepatide in adults living with obesity and T2D.
- Conditions
- Overweight and Obesity
- Being tested
- WVE-007
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WVE-007Drug
Stereopure siRNA oligonucleotide
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Part A: Experimental WVE-007 (Dose 1) or Placebo Part B non-T2D: Experimental WVE-007 (Dose 1) or Placebo Receives: Drug: WVE-007 |
| Cohort 2 | Experimental | Part A: Experimental WVE-007 (Dose 2) or Placebo Part B non-T2D: Experimental WVE-007 (Dose 2) or Placebo Receives: Drug: WVE-007 |
| Cohort 3 | Experimental | Part A: Experimental WVE-007 (Dose 3) or Placebo Receives: Drug: WVE-007 |
| Cohort 4 | Experimental | Part A: Experimental WVE-007 (Dose 4) or Placebo Part B T2D: Experimental WVE-007 (Dose 4) or Placebo Receives: Drug: WVE-007 |
| Cohort 5 | Experimental | Part A: Experimental WVE-007 (Dose 5) or Placebo Part B T2D: Experimental WVE-007 (Dose 5) or Placebo Receives: Drug: WVE-007 |
| Cohort 6 | Experimental | Part B T2D: Experimental WVE-007 (Dose 6) or Placebo with weekly tirzepatide Receives: Drug: WVE-007 |
| Cohort 7 | Experimental | Part B T2D: Experimental WVE-007 (Dose 7) or Placebo with weekly tirzepatide Receives: Drug: WVE-007 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of participants with treatment emergent adverse events
Measured: Day 1 through end of study
Secondary outcomes (3)
Maximum concentration of WVE-007 in plasma (Cmax)
Measured: Part A:Day 1 through 169 Part B: Day 1 through 253
Area under the plasma concentration time curve for WVE-007 from time 0 to last measurable concentration (AUClast)
Measured: Part A:Day 1 through 169 Part B: Day 1 through 253
Change over time from baseline levels of serum activin E
Measured: Part A:Day 1 through 169 Part B: Day 1 through 337
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start31 Jan 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wave Life Sciences USA, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, MD, Study director, Wave Life Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06842186
- Sponsor's protocol ID
- WVE-007-001
- Acronym
- INLIGHT
- Status last verified
- Oct 2026
- First submitted
- 29 Jan 2025
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2a, 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
- ClinicalTrials.gov ID
- NCT06842186
- Acronym / sponsor ID
- INLIGHT / WVE-007-001
- Conditions
- Overweight and Obesity
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Wave Life Sciences USA, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Jan 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 24 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 adult with obesity, with or without Type 2 Diabetes (T2D and non-T2D, respectively). In addition, Part B includes two dose groups that will receive WVE-007 and tirzepatide in adults living with obesity and T2D.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: WVE-007Part A: Experimental WVE-007 (Dose 1) or Placebo Part B non-T2D: Experimental WVE-007 (Dose 1) or Placebo |
| Cohort 2 | Experimental | Drug: WVE-007Part A: Experimental WVE-007 (Dose 2) or Placebo Part B non-T2D: Experimental WVE-007 (Dose 2) or Placebo |
| Cohort 3 | Experimental | Drug: WVE-007Part A: Experimental WVE-007 (Dose 3) or Placebo |
| Cohort 4 | Experimental | Drug: WVE-007Part A: Experimental WVE-007 (Dose 4) or Placebo Part B T2D: Experimental WVE-007 (Dose 4) or Placebo |
| Cohort 5 | Experimental | Drug: WVE-007Part A: Experimental WVE-007 (Dose 5) or Placebo Part B T2D: Experimental WVE-007 (Dose 5) or Placebo |
| Cohort 6 | Experimental | Drug: WVE-007Part B T2D: Experimental WVE-007 (Dose 6) or Placebo with weekly tirzepatide |
| Cohort 7 | Experimental | Drug: WVE-007Part B T2D: Experimental WVE-007 (Dose 7) or Placebo with weekly tirzepatide |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
- Male and female participants aged 18 to 75 years
- BMI 35 to 50 kg/m2 (inclusive)
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WVE-007Stereopure siRNA oligonucleotide | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6, Cohort 7 |
Primary outcome
The proportion of participants with treatment emergent adverse events
Time frame: Day 1 through end of study
3 secondary outcomes
Maximum concentration of WVE-007 in plasma (Cmax)
Time frame: Part A:Day 1 through 169 Part B: Day 1 through 253
Area under the plasma concentration time curve for WVE-007 from time 0 to last measurable concentration (AUClast)
Time frame: Part A:Day 1 through 169 Part B: Day 1 through 253
Change over time from baseline levels of serum activin E
Time frame: Part A:Day 1 through 169 Part B: Day 1 through 337
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Medical Director, MD study director
Wave Life Sciences
7 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing WVE-007 in people with Overweight and Obesity, run by Wave Life Sciences USA, Inc. at 7 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Romania, United Kingdom, Moldova. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Operations (855-215-4687, Clinicaltrials@wavelifesci.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of participants with treatment emergent adverse events (time frame: Day 1 through end of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.