ClinicalTrials.gg
Not yet recruitingNCT07923630VITAL-HUpdated Nov 6, 2026

Validation & Intervention Testing for Aging, Longevity and Healthspan

A Phase 2 interventional study of Dapagliflozin 10Mg Oral Tablet and Semaglutide oral in Aging and Functional Decline, sponsored by The University of Texas Health Science Center at San Antonio. Not yet recruiting at 5 sites in United States. Open to participants aged 60 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-06.

Sponsored by The University of Texas Health Science Center at San Antonio · Phase 2, Interventional, and Treatment

Updated Nov 6, 2026Newly registeredGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
1,200
Allocation
Randomized
Ages
60 Years to 75 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Aging
  • Functional Decline

Keywords

  • Community dwelling
  • Lifespan
  • Healthspan
03

In context

Lead sponsor

The University of Texas Health Science Center at San Antonio is the lead sponsor of 445 studies on the registry; 89 are open to participants now.

Of its 65 completed or terminated interventional studies of FDA-regulated products, 35 (54%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
    • 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 (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 ≥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. to any of the study drugs
  7. Prisoner
  8. Females who are pregnant, breastfeeding, or planning to become pregnant
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
1,200 participants (estimated)

Study arms

  • Experimental
    Semaglutide Arm

    Semaglutide and dapagliflozin placebo are administered

    Drug: Semaglutide oral · Other: Placebo

  • Experimental
    Dapagliflozin Arm

    Dapagliflozin and semaglutide placebo are administered

    Drug: Dapagliflozin 10Mg Oral Tablet · Other: Placebo

  • Placebo comparator
    Placebo Arm

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

    Other: Placebo

Interventions

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

    Also known as: Farxiga 10 mg

  • DrugSemaglutide 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.

    Also known as: Weygovy pill

  • OtherPlacebo

    Participants will take two placebo pills daily for 36 months

    Also known as: Inert tablet

06

What researchers measure

Primary outcomes

  1. Continuous Short Physical Performance Battery SPPB

    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.

    Time frame: Baseline to end of study (approximately 36 months)

Secondary outcomes

  1. Physiological reserve

    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.

    Time frame: Baseline to end of study (approximately 36 months)

Other outcomes

  1. 6-minute Walk Test

    Distance walked at self-selected normal pace over 6 minutes

    Time frame: Baseline to end of study (approximately 36 months)

  2. Grip strength

    Isometric hand grip strength during a 3-5 second period

    Time frame: Baseline to end of study (approximately 36 months)

  3. Montreal Cognitive Assessment (MOCA)

    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.

    Time frame: Baseline to end of study (approximately 36 months)

  4. Center for Epidemiological Studies Depression Scale (CES-D)

    Total scores range from 0 to 60, with higher scores indicating greater depressive symptom burden.

    Time frame: Baseline to end of study (approximately 36 months)

  5. Glycosolated hemoglobin (HbA1c)

    Percentage of glucose in hemoglobin averaged over a 3 month period

    Time frame: Baseline to end of study (approximately 36 months)

  6. Body weight

    Body weight (kg)

    Time frame: Baseline to end of study (approximately 36 months)

  7. Body mass index (BMI)

    Body mass index is calculated using weight (kg) and height (meters)

    Time frame: Baseline to 36 weeks

  8. Visual acuity

    Measured using Snellen test

    Time frame: Baseline to end of study (approximately 36 months)

  9. Hearing thresholds (dB)

    Hearing is tested using a hand-held portable audiometer at various frequencies.

    Time frame: Baseline to end of study (approximately 36 months)

  10. Pulmonary Function (FEV1)

    Measure of peak expiratory flow (FEV1) using a portable spirometer.

    Time frame: Baseline to 36 months

  11. Fat free mass

    Measured by Bioelectrical Impedance Analysis (BIA)

    Time frame: Baseline to end of study (approximately 36 months)

  12. Body fat percentage

    Measured by Bioelectrical Impedance Analysis (BIA)

    Time frame: Baseline to end of study (approximately 36 months)

  13. Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)

    calculated from fasting insulin and fasting glucose

    Time frame: Baseline to end of study (approximately 36 months)

  14. Nutritional Status

    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.

    Time frame: Baseline to end of study (approximately 36 months)

07

Study locations

5 sites
  • Texas Diabetes Institute
    San Antonio, Texas 78207, United States
  • San Antonio Food Bank
    San Antonio, Texas 78227, United States
  • Barshop Institute Mobile Research Clinic
    San Antonio, Texas 78229, United States
  • Sam and Ann Barshop Institute for Longevity & Aging Studies
    San Antonio, Texas 78229, United States
  • South Texas Veterans Health Care System
    San Antonio, Texas 78229, United States
08

References and documents

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

Time frame: After study completion and when data are analyzed

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jan 2027; primary completion for Dec 2030, 47 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 26, 2026
First posted
Nov 6, 2026
StartEst.
Jan 2027
Primary completionEst.
Dec 2030
CompletionEst.
Feb 2031
Last update
Nov 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 6, 2026
Show all 1 update
  1. Nov 6, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07923630
Collaborators
Department of Health and Human Services
Responsible party
Elena Volpi (Professor, The University of Texas Health Science Center at San Antonio) — Principal investigator
First posted
Nov 6, 2026
Start date
Jan 2027 (estimated)
Primary completion
Dec 2030 (estimated)
Completion
Feb 2031 (estimated)
Last update
Nov 6, 2026

Study contacts

Elena Volpi, MD, PhD
Contact
volpi@uthscsa.edu
(210) 562- 6139
Eloisa Martinez
Contact
martineze42@uthscsa.edu
210-562-5078

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Studies of the drug tested here: Dapagliflozin

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