Skip to main content
Delfa

← All trials/NCT07871799

ELITE

CompletedPhase 2

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

Evidence-Based Longevity Interventions and Targeted Engagement (E.L.I.T.E.)

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

-

Actual enrollment

31

Study population

Healthy volunteers

Eligibility highlights

•BMI ≥25•HbA1c ≤6.5%•Healthy volunteers

Primary endpoint

•Muscular-Immune-Cognitive Composite (MIC-C) Score

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07871799
Org study ID2361-25-SMC
Secondary IDISRCTN84791030ISRCTN
Secondary IDMOH_2026-07-21_016947Israeli Ministry of Health MyTrial Registry

Timeline

Milestones

Study start2025-11-17actual
Primary completion2026-02-25actual
Study completion2026-02-25actual
Study first posted2026-10-13actual
Last update posted2026-10-13actual

Assets

Investigational agents

Semaglutide

Who this study enrolls

Healthy volunteers

Who can enroll

Minimum age50 Years
Maximum age80 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

•Male or female, aged 50 to 80 years, inclusive.
•Generally healthy, as determined by medical history and screening assessments, with no more than 2 stable, well-controlled chronic conditions.
•Body-mass index (BMI) ≥25 kg/m².
•No diagnosis of Type 1 or Type 2 diabetes mellitus and screening HbA1c <6.5%.
•Willing and able to provide written informed consent prior to any study-related procedures.
•Willing and able to comply with all study procedures, including daily use of a compatible smartphone or tablet for app-based digital biomarker data collection and completion of required home study procedures.
•If female and of childbearing potential, must be postmenopausal for at least one year.

Exclusion criteria

Metabolic \& Endocrine

•Diagnosis of Type 1 or Type 2 diabetes mellitus, or HbA1c ≥6.5% at screening.
•History of pancreatitis, medullary thyroid carcinoma (personal or family), or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
•History of significant or recurrent hypoglycemia requiring medical intervention.
•Known Child-Pugh Class B or C hepatic disease.
•BMI <25 kg/m².

Renal \& Genitourinary

•Impaired renal function, defined as an estimated glomerular filtration rate (eGFR) <45 mL/min/1.73 m² at screening, or a reported renal problem.
•History of diabetic ketoacidosis (DKA).
•History of recurrent (≥3 in the last 12 months) or severe urinary tract infections or genital mycotic infections.

Gastrointestinal

•Self-reported history of severe gastrointestinal disease such as gastroparesis, inflammatory bowel disease (Crohn's disease or ulcerative colitis), or chronic malabsorption syndromes; known gallstones; significant hypertriglyceridemia (e.g., triglycerides >500 mg/dL); or prior biliary tract surgery.
•Previous bariatric surgery that may affect drug absorption (e.g., gastric bypass).

Cardiovascular

•New York Heart Association (NYHA) Class III or IV congestive heart failure.
•History of myocardial infarction, unstable angina, or stroke within the 6 months prior to screening.
•Symptomatic hypotension or a screening systolic blood pressure consistently <100 mmHg.

Other Medical Conditions

•Active malignancy within the last 2 years, with the exception of successfully treated non-melanoma skin cancer or cervical carcinoma in situ.
•Known significant active liver disease (e.g., active hepatitis or cirrhosis), or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.5 times the upper limit of normal at screening.
•History of lactic acidosis.
•Any condition associated with an increased risk of lactic acidosis, such as severe dehydration or acute systemic illness at the time of screening.
•Current or recent (within 2 years) diagnosis of anorexia nervosa, bulimia, or another eating disorder.
•Current use of known nephrotoxic agents (e.g., high-dose NSAIDs or contrast agents) that may exacerbate renal risk.

Concomitant Medications \& Lifestyle

•Current use of any other glucose-lowering agents (e.g., insulin, other GLP-1 receptor agonists, DPP-4 inhibitors, or sulfonylureas).
•Chronic use of systemic corticosteroids or loop diuretics. Inhaled or topical corticosteroids and stable replacement doses (e.g., hydrocortisone <20 mg/day) are acceptable.
•Participation in another interventional clinical trial within the 3 months prior to screening.
•Excessive alcohol consumption, defined as more than 14 standard drinks per week for men or 7 per week for women, or a history of alcohol use disorder.
•Known allergy or hypersensitivity to metformin, semaglutide, any SGLT-2 inhibitor, or any of their components or excipients.

General

•Any condition which, in the opinion of the investigator, would place the participant at undue risk or interfere with the study's conduct or the interpretation of its results.
•Cognitive or mental impairment that would prevent the participant from understanding the consent form, adhering to daily tasks, or providing reliable data.

Endpoints (11)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)
9
Safety / tolerability / PK
1
Other clinical outcomes
1

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Incidence, Severity, and Relatedness of Adverse Events and Serious Adverse Events

Time frame:Baseline to Week 8

descriptive

Other clinical outcomes

1 endpoint
Secondary/protocol endpoint

Overall Protocol Adherence Rate

Time frame:Throughout the 8-week intervention period.

descriptive

Other (unclassified)

9 endpoints
Primary/protocol endpoint/low confidence

Change From Baseline in Muscular-Immune-Cognitive Composite (MIC-C) Score at Week 8

Time frame:Baseline to Week 8

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change From Baseline in MIC-C Muscular Subdomain Score at Week 8

Time frame:Baseline to Week 8

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change From Baseline in MIC-C Immune Subdomain Score at Week 8

Time frame:Baseline to Week 8

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change From Baseline in MIC-C Cognitive Subdomain Score at Week 8

Time frame:Baseline to Week 8

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Association Between Change in the Longitudinal Multimodal Digital Health Composite and Change in MIC-C

Time frame:Baseline to Week 8

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Study Completion Rate

Time frame:Week 8

descriptive

Other/protocol endpoint/low confidence

Predictive Performance of the CRS/ADAPT Score for Week 8 MIC-C Response

Time frame:Baseline to Week 8

descriptive

Other/protocol endpoint/low confidence

Slope of the Longitudinal Multimodal Digital Health Composite

Time frame:Baseline through Week 8

descriptive

Other/protocol endpoint/low confidence

Variability of the Longitudinal Multimodal Digital Health Composite

Time frame:Baseline through Week 8

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateNovember 5, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.