The University of Texas Health Science Center at San Antonio
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.
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 bo…
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…
Participants will take one dapagliflozin plus one placebo pill daily for 36 months
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.
Participants will take two placebo pills daily for 36 months