ELITE: Deep Profiling and Algorithmic Polytherapy to Map Individual Response in Healthy Aging

What Was Tested

In this phase 2 trial, researchers set out to test Semaglutide.

The purpose of ELITE was to characterize individual response to multidomain healthy-aging interventions over approximately eight weeks by combining a clinical measure of muscular, immune and cognitive function with frequent digital monitoring between study visits.

The primary outcome was change from baseline to Week 8 in the Muscular-Immune-Cognitive Composite (MIC-C).

It had two arms (groups): Arm A: Metformin + Semaglutide + AgeBiotics (experimental) and Arm B: Metformin + Empagliflozin + AgeBiotics (experimental).

The registry classes the interventions as dietary supplement and drug.

More on the Plan

The study was designed to characterize individual response to multidomain healthy-aging interventions by combining randomized treatment with frequent digital monitoring, scheduled clinical and functional assessment, multi-omic profiling and a prespecified Bayesian response framework.

The central scientific question was whether change during treatment could be followed at higher temporal resolution than is possible with clinic visits alone, and whether those longitudinal digital trajectories could be related to measured changes in muscular, immune and cognitive function.

Treatment exposure, digital measurements, clinical assessments and molecular data were therefore organized on the same participant timeline.

ELITE evaluated a protocol-defined algorithmic polytherapy intervention that integrated multicomponent treatment exposure, high-frequency longitudinal digital measurement, a prespecified Composite Response Score (CRS/ADAPT Score), Bayesian response-state classification, and physician-supervised clinical review.

Who Took Part

The registry lists 31 actual participants took part.

It was open to people of any sex aged from 50 years up to 80 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Male or female, aged 50 to 80 years, inclusive. Body-mass index (BMI) ≥25 kg/m². Willing and able to provide written informed consent prior to any study-related procedures. If female and of childbearing potential, must be postmenopausal for at least one year.

The full record lists 7 inclusion and 26 exclusion criteria; among the exclusions: history of pancreatitis, medullary thyroid carcinoma (personal or family), or multiple endocrine neoplasia syndrome type 2 (men 2); known child-pugh class b or c hepatic disease; BMI \<25 kg/m².

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Because people in this Semaglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Semaglutide group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Semaglutide study: the participants and staff both knew the treatment.

It started in 2025-11-17 with completion listed for 2026-02-25.

It ran at 1 site in Israel.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change From Baseline in Muscular-Immune-Cognitive Composite (MIC-C) Score at Week 8 (time frame: Baseline to Week 8).

It also tracked 7 secondary outcomes, for example Change From Baseline in MIC-C Muscular Subdomain Score at Week 8, Change From Baseline in MIC-C Immune Subdomain Score at Week 8, Change From Baseline in MIC-C Cognitive Subdomain Score at Week 8, Association Between Change in the Longitudinal Multimodal Digital Health Composite and Change in MIC-C, Incidence, Severity, and Relatedness of Adverse Events and Serious Adverse Events and Study Completion Rate.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Semaglutide in 31 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, all human trials.