NCT05972564 (SADIE2) is a Phase 1, PHASE2 clinical trial of Empagliflozin 25 MG in Obesity, sponsored by Vanderbilt University Medical Center.

Who is sponsoring NCT05972564?

NCT05972564 is sponsored by Vanderbilt University Medical Center.

What drugs are being tested in NCT05972564?

Interventions in NCT05972564: Empagliflozin 25 MG, Placebo.

What condition does NCT05972564 study?

NCT05972564 studies Obesity, Metabolic Syndrome.

Is NCT05972564 still recruiting?

NCT05972564 is currently recruiting now. Last updated 13 June 2025.

Last reviewed 2025-06-13 · How we verify

NCT05972564: SADIE2

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function

Recruiting now Phase 1, PHASE2 Last updated 13 June 2025

What this trial tests

Phase 1, PHASE2 trial testing Empagliflozin 25 MG in Obesity in 74 participants. Currently enrolling.

Timeline

6 September 2023

Primary endpoint
30 September 2026

30 December 2026

Quick facts

Lead sponsor	Vanderbilt University Medical Center
Phase	Phase 1, PHASE2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	basic science
Enrollment	74
Start date	6 September 2023
Primary completion	30 September 2026
Estimated completion	30 December 2026
Sites	1 location across United States

Drugs / interventions tested

Empagliflozin 25 MG — full drug profile →
Placebo

Conditions studied

Obesity — all drugs for Obesity →
Metabolic Syndrome — all drugs for Metabolic Syndrome →

Sponsor

Vanderbilt University Medical Center

Who can join

Adults 18 to 70, any sex, with Obesity or Metabolic Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Obesity is associated with increased cardiometabolic disease risk due, in part, to heightened chronic inflammation arising from adipose tissue. There are no current targeted therapies to prevent or reverse the chronic inflammation of obesity, and a better understanding of these inflammatory pathways in humans is key to future therapeutic interventions. This trial will determine both the anti-inflammatory potential of the SGLT2 inhibitor empagliflozin, and the contribution of adipose inflammation to surrogate measures of cardiovascular disease in a randomized controlled trial of obese patients.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Systemic and organ-specific anti-inflammatory effects of sodium-glucose cotransporter-2 inhibitors.
Mashayekhi M, Safa BI, Gonzalez MSC, Kim SF, et al · · 2024 · cited 23× · PMID 38423898 · DOI 10.1016/j.tem.2024.02.003

Verify or expand the search:

Other trials of Empagliflozin 25 MG

Trials testing the same drug.

NCT07053306 — SGLT2i, Ketoacidosis, Volume Contraction, and Insulinopenia · Phase 1 · recruiting
NCT07053293 — SGLT2i, Hepatic Glucose Production, and SNS · EARLY_PHASE1 · recruiting
NCT05715814 — meChANisms and sAfety of SGLT2 Inhibition in peRitoneal dialYsis · Phase 3 · recruiting
NCT06578676 — To Evaluate the Safety and Pharmacokinetic Interaction Between HODO-22251 and HODO-22252 in Healthy Adults · Phase 1 · recruiting
NCT06249932 — Empagliflozin in Heart Failure with Reduced Ejection Fraction and End Stage Renal Disease · Phase 4 · recruiting

Other recruiting trials for Obesity

Currently open trials in the same condition.

NCT07403604 — Effect of Insulin Lowering on Lipogenesis · Phase 1 · recruiting
NCT07509307 — AMAZE 6: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Knee · Phase 3 · recruiting
NCT07272837 — Impact of Semaglutide (Ozempic/Wegovy®) on Heart and Muscle Mass · recruiting
NCT07481630 — A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Knee Osteoart · Phase 3 · recruiting
NCT07527195 — Understanding the Effect of CagriSema, Cagrilintide, and Semaglutide on Muscle Health (Role of Amylin Signature in Muscl · Phase 1 · recruiting

Other Vanderbilt University Medical Center trials

Trials by the same sponsor.

NCT07005037 — Swallowing Impairments in ICU Survivors and Community-Dwelling Adults · not yet recruiting
NCT07527273 — Cognitive Enhancement in Recurrent Depression (The COG-D-R Study) · NA · not yet recruiting
NCT07295288 — Botox Injections in Non-Cranial Nerve VII Innervated Muscles for Facial Synkinesis · Phase 4 · not yet recruiting
NCT07431541 — Topical Carboxytherapy Paste Following Microneedling · Phase 1, PHASE2 · not yet recruiting
NCT07224711 — The Impact of Perioperative Lidocaine Infusions on Enhanced Recovery After Non-Cardiac Surgery · Phase 4 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05972564 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Vanderbilt University Medical Center
Last refreshed: 13 June 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05972564.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing