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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Part A: Experimental WVE-007 (Dose 1) or Placebo Part B Pre-T2D: Experimental WVE-007 (Dose 1) or Placebo |
|
| Cohort 2 | Experimental | Part A: Experimental WVE-007 (Dose 2) or Placebo Part B Pre-T2D: Experimental WVE-007 (Dose 2) or Placebo |
|
| Cohort 3 | Experimental | Part A: Experimental WVE-007 (Dose 3) or Placebo |
|
| Cohort 4 | Experimental | Part A: Experimental WVE-007 (Dose 4) or Placebo Part B T2D: Experimental WVE-007 (Dose 4) or Placebo |
|
| Cohort 5 | Experimental | Part A: Experimental WVE-007 (Dose 5) or Placebo Part B T2D: Experimental WVE-007 (Dose 5) or Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WVE-007 | Drug | Stereopure siRNA oligonucleotide |
|
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of participants with adverse events | Day 1 through end of study |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change of weight (kg) from baseline | Day 1 through 169 Part B: Day 1 through 337 | |
| 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 |
Inclusion Criteria: Part A
Inclusion Criteria : Part B
Exclusion Criteria: Part A
Exclusion Criteria: Part B
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Operations | Contact | 855-215-4687 | Clinicaltrials@wavelifesci.com |
| Name | Affiliation | Role |
|---|---|---|
| Medical Director, MD | Wave Life Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parexel International-EPCU Baltimore | Recruiting | Baltimore | Maryland | 21225 | United States |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Change over time from baseline levels of serum activin E | Part A:Day 1 through 169 Part B: Day 1 through 337 |
| Part A: Day 1 through 169 Part B: Day 1 through 337 |
| ARENSIA Research Clinic | Recruiting | Chisinau | MD-2025 | Moldova |
|
| Arensia Clinics S.R.L. | Recruiting | Bucharest | 011658 | Romania |
|
| Spitalul Clinic Judetean De Urgenta Cluj | Recruiting | Cluj-Napoca | 400006 | Romania |
|
| Parexel International Early Phase Clinical Unit | Recruiting | Harrow | HA1 3UJ | United Kingdom |
|
| Simbec-Orion Clinical Pharmacology | Recruiting | Merthyr Tydfil | CF48 4DR | United Kingdom |
|
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |