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Recruiting NCT06842186

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

Phase I / Phase II Interventional Overweight and Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: WVE-007.
Who it may be relevant to
Registry conditions: Overweight and Obesity. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Moldova, Romania, United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Drug WVE-007
    Stereopure siRNA oligonucleotide

Primary outcome measures

  • The proportion of participants with adverse events [Time frame: Day 1 through end of study]
Secondary outcome measures (3)
  • Maximum concentration of WVE-007 in plasma (Cmax) [Time frame: 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) [Time frame: Part A:Day 1 through 169 Part B: Day 1 through 253]
  • Change over time from baseline levels of serum activin E [Time frame: Part A:Day 1 through 169 Part B: Day 1 through 337]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Romania · 2 centers
  • Arensia Clinics S.R.L. — Bucharest
  • Spitalul Clinic Judetean De Urgenta Cluj — Cluj-Napoca
United Kingdom · 2 centers
  • Parexel International Early Phase Clinical Unit — Harrow
  • Simbec-Orion Clinical Pharmacology — Merthyr Tydfil
United States · 1 center
  • Parexel International-EPCU Baltimore — Baltimore
Moldova · 1 center
  • ARENSIA Research Clinic — Chisinau

Identifiers

NCT: NCT06842186 · WVE-007-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗