Overweight and Obesity
Conditions
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.
Interventions
DRUGWVE-007
Stereopure siRNA oligonucleotide
Sponsors
Wave Life Sciences USA, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of participants with adverse events | Day 1 through end of study |
Secondary
| Measure | Time frame |
|---|---|
| Maximum concentration of WVE-007 in plasma (Cmax) | 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) | Part A:Day 1 through 169 Part B: Day 1 through 253 |
| Change over time from baseline levels of serum activin E | Part A:Day 1 through 169 Part B: Day 1 through 337 |
Countries
Moldova, Romania, United Kingdom, United States
Contacts
CONTACTClinical Operations
STUDY_DIRECTORMedical Director, MD
Wave Life Sciences
Outcome results
None listed