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Validation & Intervention Testing for Aging, Longevity and Healthspan (VITAL-H)

3 november 2026 uppdaterad av: Elena Volpi, The University of Texas Health Science Center at San Antonio

Validation & Intervention Testing for Aging, Longevity and Healthspan (VITAL-H)

The study aims to address the gap between lifespan and healthspan (years of life free of age-related diseases and disabilities) by testing whether 2 approved U.S Food and Drug Administration (FDA) medications, dapagliflozin and semaglutide, can help people stay healthier as they age and delay the age-related functional decline. The study will test these medications over 36 months of treatment plus 6 months of observational follow up to see if they can safely maintain health and function during aging and eventually support their use for extending healthspan.

This study is being done because there are limited ways to slow down the age-related health and functional decline, and few reliable ways to measure early changes in healthspan in humans. The 2 study drugs have shown promising results in laboratory and early human studies, but more evidence is needed.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

Phase 2b, hybrid-decentralized, double-blind, randomized placebo-controlled trial to evaluate the independent effects of dapagliflozin, oral semaglutide, and placebo on functional decline in healthy adults aged 60-75 years. 1200 individuals will be randomized to parallel intervention arms and followed for 36 months of intervention plus 6 months post-intervention follow-up to evaluate changes in locomotion (continuous short physical performance battery - primary outcome), vitality (peak oxygen uptake during exercise, VO2 peak - secondary outcome). Exploratory outcomes will include changes in body composition, individual components of intrinsic capacity (IC) across multiple functional geroscience-based domains, and overall intrinsic capacity. This hybrid-decentralized clinical trial integrates wearable technology, deep phenotyping, and biomarker analyses to evaluate if the proposed therapies demonstrate meaningful differences in functional healthy longevity outcomes.

Studietyp

Interventionell

Inskrivning (Beräknad)

1200

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

  • Namn: Elena Volpi, MD, PhD
  • Telefonnummer: (210) 562- 6139
  • E-post: volpi@uthscsa.edu

Studera Kontakt Backup

Studieorter

  • Förenta staterna
    • Texas
      • San Antonio, Texas, Förenta staterna, 78229
        • South Texas Veterans Health Care System
        • Kontakt:
      • San Antonio, Texas, Förenta staterna, 78207
        • Texas Diabetes Institute
        • Kontakt:
      • San Antonio, Texas, Förenta staterna, 78229
        • Sam and Ann Barshop Institute for Longevity & Aging Studies
        • Kontakt:
      • San Antonio, Texas, Förenta staterna, 78227
        • San Antonio Food Bank
        • Kontakt:
      • San Antonio, Texas, Förenta staterna, 78229
        • Barshop Institute Mobile Research Clinic
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

60 år till 75 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  1. Ability to understand and the willingness to sign a written informed consent document.
  2. Males and females; Age 60-75
  3. Willingness to adhere to the study intervention regimen (dapagliflozin or semaglutide).
  4. Body mass index 20-40 kg/m2
  5. Community dwelling

Exclusion Criteria:

  1. Any medical condition that, in the opinion of the investigator, would place the participant at increased risk for participation.

  2. Participation in another treatment or intervention study within 6 months

  3. Use of the following medication or supplements

    • That may be used for weight or appetite control
    • That may be used for glucose lowering
    • Immunosuppressant or biologics

  4. Any of the following conditions

    • Myocardial infarction (MI), cerebrovascular accident (CVA/stroke), congestive heart failure (CHF) or revascularization procedures like percutaneous coronary intervention (stents)
    • Renal impairment with estimated glomerular filtration rate (eGFR<45)
    • Requirement of assistive devices for ambulation
    • Pancreatitis history (if cause has been removed then okay to enroll)
    • Recurrent urinary tract infections (2 or more within 6 months, or 3 or more within past 12 months)
    • Personal or family history of medullary thyroid cancer or Multiple Endocrine Neoplasia syndrome type 2
    • Active cancer (okay if in remission for ≥ 3 years or had non melanoma skin cancer)
    • Uncontrolled Hypertension above 160/90 (we will include individuals with controlled hypertension and no complications)
    • Diabetes or Hemoglobin A1c ≥6.5%
    • Multiple sclerosis, MS, Parkinson Disease, mild cognitive impairment, dementia
    • History of solid organ transplant

  5. Planned elective orthopedic surgery during the study

  6. Hypersensitivity to any of the study drugs

  7. Prisoner

  8. Females who are pregnant, breastfeeding, or planning to become pregnant

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Semaglutide Arm

Semaglutide and dapagliflozin placebo are administered
Läkemedel: Semaglutide oral

Participants will start taking a 1.5 mg semaglutide pill, titrated to 4 mg as tolerated, plus one placebo pill per day for 36 months.

Andra namn:
  • Weygovy pill
Övrig: Placebo

Participants will take two placebo pills daily for 36 months

Andra namn:
  • Inert tablett
Experimentell: Dapagliflozin Arm

Dapagliflozin and semaglutide placebo are administered
Övrig: Placebo

Participants will take two placebo pills daily for 36 months

Andra namn:
  • Inert tablett
Läkemedel: Dapagliflozin 10Mg Oral Tablet

Participants will take one dapagliflozin plus one placebo pill daily for 36 months

Andra namn:
  • Farxiga 10 mg
Placebo-jämförare: Placebo Arm

The placebo arm consists of 2 placebos, one matched to each study drug with the same ingredients for both.
Övrig: Placebo

Participants will take two placebo pills daily for 36 months

Andra namn:
  • Inert tablett

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Continuous Short Physical Performance Battery SPPB
Tidsram: Baseline to end of study (approximately 36 months)

This is a well-established objective measure of physical function that assesses standing balance, gait speed test, and repeated chair stands. The SPPB score ranges from 0 to 12, with higher scores indicating better lower extremity physical function.
Baseline to end of study (approximately 36 months)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Physiological reserve
Tidsram: Baseline to end of study (approximately 36 months)

Measured as Cardio-Pulmonary Exercise Test (CPET) on a cycle ergometer to measure maximum oxygen consumption rate (VO2 peak) during exercise during a treadmill test on a stationary bicycle.
Baseline to end of study (approximately 36 months)

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
6-minute Walk Test
Tidsram: Baseline to end of study (approximately 36 months)

Distance walked at self-selected normal pace over 6 minutes
Baseline to end of study (approximately 36 months)
Grip strength
Tidsram: Baseline to end of study (approximately 36 months)

Isometric hand grip strength during a 3-5 second period
Baseline to end of study (approximately 36 months)
Montreal Cognitive Assessment (MOCA)
Tidsram: Baseline to end of study (approximately 36 months)

Participants will complete the MOCA a brief cognitive screening tool used to assess cognitive function on person or remotely, as applicable. Scores are calculated according to the standardized scoring procedures for the version administered, with higher scores indicating better cognitive function.
Baseline to end of study (approximately 36 months)
Center for Epidemiological Studies Depression Scale (CES-D)
Tidsram: Baseline to end of study (approximately 36 months)

Total scores range from 0 to 60, with higher scores indicating greater depressive symptom burden.
Baseline to end of study (approximately 36 months)
Glycosolated hemoglobin (HbA1c)
Tidsram: Baseline to end of study (approximately 36 months)

Percentage of glucose in hemoglobin averaged over a 3 month period
Baseline to end of study (approximately 36 months)
Body weight
Tidsram: Baseline to end of study (approximately 36 months)

Body weight (kg)
Baseline to end of study (approximately 36 months)
Body mass index (BMI)
Tidsram: Baseline to 36 weeks

Body mass index is calculated using weight (kg) and height (meters)
Baseline to 36 weeks
Visual acuity
Tidsram: Baseline to end of study (approximately 36 months)

Measured using Snellen test
Baseline to end of study (approximately 36 months)
Hearing thresholds (dB)
Tidsram: Baseline to end of study (approximately 36 months)

Hearing is tested using a hand-held portable audiometer at various frequencies.
Baseline to end of study (approximately 36 months)
Pulmonary Function (FEV1)
Tidsram: Baseline to 36 months

Measure of peak expiratory flow (FEV1) using a portable spirometer.
Baseline to 36 months
Fat free mass
Tidsram: Baseline to end of study (approximately 36 months)

Measured by Bioelectrical Impedance Analysis (BIA)
Baseline to end of study (approximately 36 months)
Body fat percentage
Tidsram: Baseline to end of study (approximately 36 months)

Measured by Bioelectrical Impedance Analysis (BIA)
Baseline to end of study (approximately 36 months)
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Tidsram: Baseline to end of study (approximately 36 months)

calculated from fasting insulin and fasting glucose
Baseline to end of study (approximately 36 months)
Nutritional Status
Tidsram: Baseline to end of study (approximately 36 months)

Mini Nutritional Assessment (MNA) is a 6-item screening tool with total scores ranging from 0 to 14. Scores of 12-14 indicate normal nutritional status, 8-11 indicate risk of malnutrition, and 0-7 indicate malnourished.
Baseline to end of study (approximately 36 months)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

The University of Texas Health Science Center at San Antonio

Samarbetspartners

Department of Health and Human Services

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 januari 2027

Primärt slutförande (Beräknad)

1 december 2030

Avslutad studie (Beräknad)

1 februari 2031

Studieregistreringsdatum

Först inskickad

26 oktober 2026

Först inskickad som uppfyllde QC-kriterierna

3 november 2026

Första postat (Faktisk)

6 november 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

6 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

3 november 2026

Senast verifierad

1 november 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • STUDY00002818
  • ARPA-H/1AY2AX000159 - 01 (Annat bidrag/finansieringsnummer: DHHS)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

Only deidentified individual participant data (IPD) will be shared with the entitites involved at sites used for the study and possibly the data safety monitoring board if needed. Any public data will be shared as aggregated data on ClinicalTrials.gov or in a peer review journal.

Tidsram för IPD-delning

After study completion and when data are analyzed

IPD-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • SAV
  • ICF

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

produkt tillverkad i och exporterad från U.S.A.

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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