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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат WVE-007
  Stereopure siRNA oligonucleotide

Первичные конечные точки

• The proportion of participants with adverse events [Срок оценки: Day 1 through end of study]

Вторичные конечные точки (3)

• Maximum concentration of WVE-007 in plasma (Cmax) [Срок оценки: 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) [Срок оценки: Part A:Day 1 through 169 Part B: Day 1 through 253]
• Change over time from baseline levels of serum activin E [Срок оценки: Part A:Day 1 through 169 Part B: Day 1 through 337]

Критерии участия

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Румыния · 2 центра

• Arensia Clinics S.R.L. — Bucharest
• Spitalul Clinic Judetean De Urgenta Cluj — Cluj-Napoca

Великобритания · 2 центра

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

США · 1 центр

• Parexel International-EPCU Baltimore — Baltimore

Moldova · 1 центр

• ARENSIA Research Clinic — Chisinau

Идентификаторы

NCT: NCT06842186 · WVE-007-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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