AgingPhase 2VITAL-HNCT07923630
Validation & Intervention Testing for Aging, Longevity and Healthspan
A Phase 2 study testing Dapagliflozin 10Mg Oral Tablet and Semaglutide oral in people with Aging and Functional Decline, run by The University of Texas Health Science Center at San Antonio at 5 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging, Functional Decline
- What is being tested?
- Dapagliflozin 10Mg Oral Tablet and Semaglutide oral
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,200 participants
- Where
- 5 sitesUnited States
- Study dates
- Jan 2027to Feb 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ability to understand and the willingness to sign a written informed consent document.
- Males and females; Age 60-75
- Willingness to adhere to the study intervention regimen (dapagliflozin or semaglutide).
- Body mass index 20-40 kg/m2
- Community dwelling
Who cannot join
- Any medical condition that, in the opinion of the investigator, would place the participant at increased risk for participation.
- Participation in another treatment or intervention study within 6 months
- 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
Show all 22Show fewer
- 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
- Planned elective orthopedic surgery during the study
- Hypersensitivity to any of the study drugs
- Prisoner
- Females who are pregnant, breastfeeding, or planning to become pregnant
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites
Texas Diabetes Institute
San Antonio, Texas, 78207
Renata Belfort De Aguiar, MD, PhD, 210 -358 -7229, belfortda@uthscsa.edu
San Antonio Food Bank
San Antonio, Texas, 78227
Shreya Rao, MD, 210 567 4600, raos4@uthscsa.edu
Barshop Institute Mobile Research Clinic
San Antonio, Texas, 78229
Shreya Rao, MD, 210 567 4600, raos4@uthscsa.edu
Sam and Ann Barshop Institute for Longevity & Aging Studies
San Antonio, Texas, 78229
Tiffany Cortes, MD, 210 450 8998, cortest@uthscsa.edu
South Texas Veterans Health Care System
San Antonio, Texas, 78229
Dean L Jr. Kellogg, MD, PhD, 210 617 5311, KelloggD@uthscsa.edu
About this study
Official title: 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.
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.
- Conditions
- Aging, Functional Decline
- Being tested
- Dapagliflozin 10Mg Oral Tablet, Semaglutide oral, Placebo
- Keywords
- Community dwelling, Lifespan, Healthspan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin 10Mg Oral TabletDrug
Also called Farxiga 10 mg
Participants will take one dapagliflozin plus one placebo pill daily for 36 months
Semaglutide oralDrug
Also called Weygovy pill
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.
PlaceboOther
Also called Inert tablet
Participants will take two placebo pills daily for 36 months
| Study group | Role | What they receive |
|---|---|---|
| Semaglutide Arm | Experimental | Semaglutide and dapagliflozin placebo are administered Receives: Drug: Semaglutide oral; Other: Placebo |
| Dapagliflozin Arm | Experimental | Dapagliflozin and semaglutide placebo are administered Receives: Drug: Dapagliflozin 10Mg Oral Tablet; Other: Placebo |
| Placebo Arm | Placebo comparator | The placebo arm consists of 2 placebos, one matched to each study drug with the same ingredients for both. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline to end of study (approximately 36 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study startJan 2027 (estimated)
- Primary completionDec 2030 (estimated)
- Study completionFeb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Hybrid-decentralized, double-blind, randomized placebo-controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health and Human Services
- Responsible party
- Principal investigator, Elena Volpi, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07923630
- Sponsor's protocol ID
- STUDY00002818
- Other IDs
- ARPA-H/1AY2AX000159 - 01
- Acronym
- VITAL-H
- Status last verified
- Nov 2026
- First submitted
- 26 Oct 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation & Intervention Testing for Aging, Longevity and Healthspan (VITAL-H)
- ClinicalTrials.gov ID
- NCT07923630
- Acronym / sponsor ID
- VITAL-H / STUDY00002818
- Conditions
- Aging, Functional Decline
- Keywords
- Community dwelling, Lifespan, Healthspan
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- Department of Health and Human Services
- Study start
- Jan 2027 (estimated)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Feb 2031 (estimated)
- First posted
- 6 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Hybrid-decentralized, double-blind, randomized placebo-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Semaglutide Arm | Experimental | Drug: Semaglutide oral, Other: PlaceboSemaglutide and dapagliflozin placebo are administered |
| Dapagliflozin Arm | Experimental | Drug: Dapagliflozin 10Mg Oral Tablet, Other: PlaceboDapagliflozin and semaglutide placebo are administered |
| Placebo Arm | Placebo comparator | Other: PlaceboThe placebo arm consists of 2 placebos, one matched to each study drug with the same ingredients for both. |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ability to understand and the willingness to sign a written informed consent document.
- Males and females; Age 60-75
- Willingness to adhere to the study intervention regimen (dapagliflozin or semaglutide).
- Body mass index 20-40 kg/m2
- Community dwelling
Key exclusion criteria (22 listed)
- Any medical condition that, in the opinion of the investigator, would place the participant at increased risk for participation.
- Participation in another treatment or intervention study within 6 months
- Use of the following medication or supplements
- Any of the following conditions
- Planned elective orthopedic surgery during the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dapagliflozin 10Mg Oral TabletAlso: Farxiga 10 mgParticipants will take one dapagliflozin plus one placebo pill daily for 36 months | Drug | Dapagliflozin Arm |
| Semaglutide oralAlso: Weygovy pillParticipants will start taking a 1.5 mg semaglutide pill, titrated to 4 mg as tolerated, plus one placebo pill per day for 36 months. | Drug | Semaglutide Arm |
| PlaceboAlso: Inert tabletParticipants will take two placebo pills daily for 36 months | Other | Dapagliflozin Arm, Placebo Arm, Semaglutide Arm |
Primary outcome
Continuous Short Physical Performance Battery SPPB
Time frame: 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.
1 secondary outcome
Physiological reserve
Time frame: Baseline to end of study (approximately 36 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dapagliflozin 10Mg Oral Tablet and Semaglutide oral in people with Aging and Functional Decline, run by The University of Texas Health Science Center at San Antonio at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elena Volpi, MD, PhD ((210) 562- 6139, volpi@uthscsa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Continuous Short Physical Performance Battery SPPB (time frame: Baseline to end of study (approximately 36 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026; AzTrials last refreshed its copy on 6 Nov 2026.