---
title: "Klotho-Up Wellness Study | Lionheart Longevity Investor Relations"
description: "Design of the Lionheart Health Klotho-Up Wellness Study: a 12-month, open-label feasibility study of a combined approach to increasing circulating Klotho."
url: https://investors.lionheartlongevity.com/science/klotho-up-study
---

Clinical Research

# Klotho-Up Wellness Study

A 12-month, open-label, non-randomized interventional feasibility study evaluating a combined approach to increasing circulating Klotho and supporting healthspan.

Design

12-month, open-label, non-randomized interventional feasibility study

Primary focus

Muscle function, cognitive performance and immune health

Oversight

U.S. IRB approved core arm; separate IRB approval required in each outside-U.S. clinic country

## Study arms

U.S. IRB approved

### U.S. Core Arm

Participants receive a coordinated program consisting of:

* Bioelectric neuromuscular stimulation and enhanced exercise, generally two to three sessions weekly.
* A Klotho-promoting nutrition program.
* Daily supplements, including Rejuvant™, personalized SNIP Nutrition and Klotho-support supplements.
* Optional targeted bioelectric therapies addressing joint, sexual, skin, hair/scalp, gut, vision, hearing, bladder, kidney, blood pressure and inflammation health.
* U.S. IRB approval permits legally available research peptides, including Klotho peptides, with proper separate patient consent.

Requires separate IRB approval in each OUS clinic country

### Outside-U.S. Advanced Arm

The optional international arm combines the core program with physician-directed advanced interventions:

* AAV gene therapy targeting Klotho, hTERT and Follistatin.
* A personalized peptide longevity stack, including Klotho peptides, administered alongside the bioelectric and lifestyle program.
* Optional Klotho and other exosomes, from pre-differentiated cells; U.S.-sourced preferred.
* Optional umbilical cord stem cells, encapsulated MSCs and Klotho-expressing stem cells.
* Additional safety monitoring appropriate to these investigational interventions, subject to applicable local regulatory and ethics requirements.

## Assessments and outcomes

1. Visit 1Baseline
2. Visit 2\~3 months
3. Visit 3\~6 months
4. Visit 4\~12 months

The assessment program includes an extensive biomarker panel, microbiome testing and imaging.

### Primary measures

* Muscle strength
* Walking performance
* Muscle mass
* Cognition
* Memory
* Mood
* Immune and inflammatory markers
* Circulating Klotho

### Secondary measures

* Vision
* Hearing
* Joint pain
* Sexual health
* Skin elasticity
* Hair density
* Sleep
* Stress
* Bladder health
* Exercise capacity

## Study materials for clinics

[Clinic PosterPrintable study poster for participating clinics.PDF · 1 page View PDF](https://investors.lionheartlongevity.com/docs/klotho-up-clinic-poster.pdf)[Trifold BrochurePrintable patient-facing study brochure.PDF · 2 pages View PDF](https://investors.lionheartlongevity.com/docs/klotho-up-trifold-brochure.pdf)[Klotho Evidence TablePotential benefits of Klotho by health area, with primary-study references.PDF · 8 pages View PDF](https://investors.lionheartlongevity.com/docs/lionheart-klotho-evidence-table.pdf)

Disclosure

The study is designed to evaluate feasibility, safety and changes in healthspan-related outcomes. IRB approval supports research conducted under the approved protocol and does not constitute FDA approval of new treatment indications.