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Looking for participantsPhase1/Phase2

A Phase 1/2a Study of WVE-007 in Adults Living With Overweight or Obesity

Sponsor: Wave Life Sciences USA, Inc.

NCT ID: NCT06842186

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
WVE-007 (drug)
How long the study runs
Study runs about 35 months (dates as stated)
About the drug or intervention
WVE-007 — drug: Stereopure siRNA oligonucleotide
Patient visit burden
Not specified by the sponsor

In plain English

This early-stage (Phase 1/2a) study, run by Wave Life Sciences USA, Inc., is testing a new medicine called WVE-007 in adults aged 18 to 60 who are living with overweight or obesity. Part A includes people with a body mass index (BMI) of 28 to 35, while Part B includes people with a BMI of 35 to 50 who also have pre-type 2 diabetes or type 2 diabetes.

Who can take part

  • Men and women aged 18 to 60 years
  • Part A: BMI of 28 to 35, stable (within about 5%) for the previous 3 to 6 months; for some extra groups, a BMI of 28 to 40 is allowed
  • Part A: healthy in the opinion of the study doctor, based on medical history, an examination, and blood tests
  • Part B: BMI of 35 to 50
  • Part B: thyroid stimulating hormone (a blood test) within the normal range at screening; thyroid hormone tablets are allowed if the dose has been stable for the last 60 days
  • Part B: have pre-type 2 diabetes or type 2 diabetes

Who may not be able to

  • Part A: past or current heart disease, such as heart failure, heart attack, or angina, or significantly abnormal test results
  • Part A: past or current thyroid disorders
  • Part A: medical history or diagnosis of liver disease
  • Part A and B: use of any small interfering RNA (siRNA) medicine in the past 12 months
  • Part A and B: taking an experimental treatment within the last 90 days (or longer, depending on the medicine), or still in follow-up for another study
  • Part B: significant heart disease, in the opinion of the study doctor
  • Part B: taking prescription medicines such as anti-obesity or psychiatric medicines in the last 14 days (or longer, depending on the medicine), except certain blood pressure medicines and statins
  • Part B: taking more than 2 blood pressure medicines, or a change in blood pressure medicine dose in the 60 days before screening
  • Part B: taking more than 1 cholesterol-lowering medicine, or a change in dose in the 60 days before screening
  • Part B, pre-type 2 diabetes groups only: use of GLP-1 receptor agonist medicines or dual incretin agonists in the 4 months before screening
  • Part B, type 2 diabetes groups only: use of insulin or medicines that make the pancreas release insulin (including sulfonylureas, meglitinides, GLP-1 receptor agonists, dual incretin agonists, and DPP-4 inhibitors) in the 60 days before screening

What taking part involves

  • • Not stated — ask the trial team
  • • The study drug being tested is called WVE-007

Time commitment: Not stated — ask the trial team (the data does not say how many visits or how long the study lasts).

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years to 60 Years
Who
All
Number of participants
296
Started
2025-01-31
Last checked
2025-11

Plain English Summary

What is this study?

  • • Testing a new treatment for overweight and obesity
  • • Phase1/Phase2 - 296 participants
  • • The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of ascending doses of WVE-007 when administered subcutaneously (SC)

Who can take part?

  • • Ages 18 Years to 60 Years
  • • Diagnosed with overweight and obesity

Where?

  • • Harrow - Parexel International Early Phase Clinical Unit
  • • Merthyr Tydfil - Simbec-Orion Clinical Pharmacology

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Overweight and Obesity

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 60 Years
  • Who can join: All genders

What the study is looking for

  • ✓Part A
  • ✓Male and female participants aged 18 to 60 years
  • ✓Healthy, in the opinion of the Investigator, as determined by prestudy medical history, physical examination, and...
  • ✓Inclusion Criteria : Part B
  • ✓BMI 35 to 50 kg/m2 (inclusive)

Who cannot take part

  • ✗Part A
  • ✗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...
See the full criteria
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.

Where Is This Study? (2 UK sites)

Parexel International Early Phase Clinical Unit

Harrow HA1 3UJ, United Kingdom

Recruiting
Site contact (verified)

Simbec-Orion Clinical Pharmacology

Merthyr Tydfil CF48 4DR, United Kingdom

Recruiting
Site contact (verified)

How to Get in Touch

Clinical Operations

Sponsor contact

CONTACT

855-215-4687 Clinicaltrials@wavelifesci.com
Data sourced from ClinicalTrials.gov · Last verified: 2025-11