Clinical trial Recruiting at 1 site Phase 4 Interventional Ages 19 and up

Evaluating Enavogliflozin for Heart and Kidney Health in Type 2 Diabetes

Official title: A Prospective, Open, Registry-based Randomized, Controlled, Investigator Initiated Trial of Enavogliflozin(ENVlo) to EvaLuate Cardio-renal Outcome in Type 2 Diabetes Mellitus Patients (ENVELOP Study)

Run by Yonsei University · NCT06642623 · Data updated 2026-11-12

This study is testing if a new diabetes medication called enavogliflozin can improve heart and kidney health in adults with type 2 diabetes compared to other similar medications.

More Cardiovascular Diseases trials

Quick facts

PhasePhase 4
Study typeInterventional
Ages19 Years and up
SexAll
Enrollment2862 (estimated)
SponsorYonsei University
Academic / other
Locations1 site (Seoul)
StatusRecruiting
StartedJanuary 22, 2024
Main results expectedSeptember 30, 2029
Study endsDecember 31, 2030
Registry record updatedOctober 15, 2024
Trial IDNCT06642623 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 19 or older with type 2 diabetes who have a history of or are at risk for cardiovascular disease.

Probably not a fit

Patients with other types of diabetes, severe kidney issues, or major comorbidities may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of enavogliflozin, a sodium-glucose cotransporter-2 (SGLT2) inhibitor, on cardiovascular and renal outcomes in adults with type 2 diabetes. The study is a multicenter, randomized, open-label trial comparing enavogliflozin to other established SGLT2 inhibitors like dapagliflozin and empagliflozin. A total of 2,862 participants will be enrolled, and the primary goal is to assess the time to the first occurrence of major adverse cardiovascular and renal events. This research aims to provide insights into the long-term benefits of enavogliflozin in this patient population.

Why it matters

Potential benefit: If successful, this study could provide evidence for the long-term cardiovascular and renal benefits of enavogliflozin in patients with type 2 diabetes.

How similar studies have gone: Other studies have shown success with SGLT2 inhibitors in improving cardiovascular and renal outcomes, making this approach promising.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Male and female adults aged 19 years and older at screening
2. Subjects diagnosed with T2D at screening
3. Subjects on treatment with or requiring treatment with enavogliflozin, dapagliflozin, or empagliflozin within the scope of label and reimbursement criteria

Exclusion Criteria:

1. Subjects with different types of diabetes mellitus other than T2D
2. Subjects with moderate to severe hepatic impairment
3. Subjects with contraindications to SGLT-2 inhibitors, i.e., kidney function disorders with estimated glomerular filtration (eGFR) \<60 mL/min/1.73 m2, end stage renal disease (ESRD), or on dialysis
4. Subjects with major comorbidities
5. Subjects with a history of hypersensitivity to enavogliflozin, dapagliflozin, or empagliflozin and any of its components
6. Pregnant or breastfeeding women

Where it's running

  • Department of Internal Medicine, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul 03722, Republic of Korea
    Seoul, South Korea
    Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.