A Phase 1/2a Study of WVE-007 in Adults Living With Overweight or Obesity
ConditionOverweight and Obesity
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-60
SponsorWave Life Sciences USA, Inc.
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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 60 years
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
WVE-007
DrugStereopure siRNA oligonucleotide
Treatment groups
296 Participants
are divided into 5 treatment groupsGroup A: Cohort 1Experimental treatment 1 intervention
Group B: Cohort 2Experimental treatment 1 intervention
Group C: Cohort 3Experimental treatment 1 intervention
Group D: Cohort 4Experimental treatment 1 intervention
Group E: Cohort 5Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The proportion of participants with adverse events
Time frame
Day 1 through end of studySecondary outcomes
1
Maximum concentration of WVE-007 in plasma (Cmax)
Time frame
Part A:Day 1 through 169 Part B: Day 1 through 2532
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 2533
Change over time from baseline levels of serum activin E
Time frame
Part A:Day 1 through 169 Part B: Day 1 through 337Other outcomes
1
Percent change of weight (kg) from baseline
Time frame
Day 1 through 169 Part B: Day 1 through 3372
Body composition changes as follows: Change in body fat percentage from baseline, percent change of visceral fat (kg) from baseline, and percent change in fat-free mass (kg) from baseline
Time frame
Part A: Day 1 through 169 Part B: Day 1 through 337Sponsors and contacts
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Source ClinicalTrials.gov