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The "Reducing Inflammation for Greater Health Trial (RIGHT)" Study-Concept, Rationale, and Design.

Sebastian E Sattui1, Marnie Bertolet2, Daniel E Forman1,3,4

  • 1Department of Medicine, School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.

Journal of the American Geriatrics Society
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PubMed
Summary
This summary is machine-generated.

The RIGHT study investigates if clazkizumab, an interleukin-6 (IL-6) inhibitor, can improve physical and cognitive function in older adults. This trial aims to slow age-related decline and assess the geroscience hypothesis.

Keywords:
agingclinical trialinflammation

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Area of Science:

  • Gerontology and Aging Research
  • Immunology and Inflammation
  • Clinical Trials and Therapeutics

Background:

  • Aging is associated with chronic low-grade inflammation (inflammaging), linked to functional decline.
  • Interleukin-6 (IL-6) is a key pro-inflammatory cytokine implicated in age-related diseases and functional impairment.
  • Targeting IL-6 may offer a therapeutic strategy to mitigate aging-related functional decline.

Purpose of the Study:

  • To evaluate the efficacy of clazkizumab, an IL-6 inhibitor, in improving or slowing the decline of physical, cognitive, and vascular function in older adults.
  • To test the geroscience hypothesis that intervening in the aging process can lead to broad health improvements.
  • To assess the safety and tolerability of clazkizumab in this population.

Main Methods:

  • A single-center, randomized, double-blind, placebo-controlled trial (RIGHT study).
  • Enrollment of participants aged ≥70 years with low-to-moderate physical function and elevated IL-6 levels.
  • Treatment with clazkizumab (5 mg subcutaneous injection every 4 weeks for 24 weeks) or placebo, with walking speed as the primary outcome.

Main Results:

  • Primary outcome: change in 400m walking speed over 24 weeks.
  • Secondary outcomes: assessments of physical function (SPPB, oxygen consumption, fatigability), cognitive function, vascular health, inflammatory markers (IL-6, CRP), and safety.
  • Exploration of 6-month changes in mobility and other health aspects.

Conclusions:

  • The RIGHT study will provide crucial data on the potential of IL-6 inhibition to combat age-related functional decline.
  • Findings will inform the validity of targeting aging mechanisms for healthspan extension.
  • The study will establish the safety profile and efficacy of clazkizumab in an older adult cohort.