CLINICAL TRIALS PROFILE FOR STEGLATRO

All Clinical Trials for STEGLATRO

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03717194 ↗	Effect of Ertugliflozin on Cardiac Function in Diabetes	Recruiting	MSD Korea Ltd.	Phase 3	2019-06-01	The aim of this study is to investigate the beneficial role of ertugliflozin, a new SGLT2 inhibitor, in cardiac function via measuring GLS as well as other hemodynamic factors using echocardiogram in patients with T2D and HF, who are not controlled with oral antidiabetic medications including DPP4 inhibitors.
NCT03717194 ↗	Effect of Ertugliflozin on Cardiac Function in Diabetes	Recruiting	Soo Lim	Phase 3	2019-06-01	The aim of this study is to investigate the beneficial role of ertugliflozin, a new SGLT2 inhibitor, in cardiac function via measuring GLS as well as other hemodynamic factors using echocardiogram in patients with T2D and HF, who are not controlled with oral antidiabetic medications including DPP4 inhibitors.
NCT04027530 ↗	Renal Oxygenation, Oxygen Consumption and Hemodynamic Kinetics in Type 2 DIabetes: an Ertugliflozin Study.	Recruiting	VU University Medical Center	Phase 4	2020-12-10	Current study will render insight in to the role of renal hypoxia in the diabetic kidney and is able to associate its finding with measurements of renal perfusion and glomerular filtration rate. Moreover, this research will focus on the effects of sodium-glucose cotransporter 2 inhibition on renal tissue oxygenation and oxygen consumption as well as a change in intrarenal hemodynamics and perfusion, and a shift of fuel metabolites. Elucidation the mechanisms underlying the effects of SGLT2 inhibition will advance our knowledge and contribute to their optimal clinical utilization in the treatment of chronic kidney disease in diabetes and possibly beyond.
NCT04231331 ↗	Ertugliflozin for Functional Mitral Regurgitation	Recruiting	Merck Sharp & Dohme Corp.	Phase 3	2020-11-04	In patients with heart failure (HF) and left ventricular (LV) dilation, adverse LV remodeling causes tethering of mitral valve (MV) preventing sufficient coaptation of normal leaflets and resulting in functional MR. Because secondary functional MR usually develops as a result of LV dysfunction, guideline-directed medical therapy for HF forms the mainstay of therapy. However, beta blockers, angiotensin-converting-enzyme (ACE) inhibitors, and angiotensin receptor blockers (ARB) fail to reverse adverse LV remodeling and functional MR, and the morbidity and mortality of patients with functional MR remain high despite standard medical therapy. Randomized trials to explore cardiovascular (CV) benefit of the sodium-glucose co-transporter-2 (SGLT2) inhibitor have been performed and showed a significant reduction on the risk of CV death or hospitalization for HF. However, its effect on cardiac structure and function was not evaluated and further mechanistic studies are needed to interpret beneficial clinical effects of the SGLT2 inhibitors. Based on studies demonstrating SGLT2 inhibitors' favorable effects on LV modeling, investigators hypothesize that SGLT2 inhibitor, ertugliflozin, is effective on improving MR in patients with functional MR secondary to LV dysfunction and try to examine this hypothesis in a multicenter, double-blind, randomized comparison study using echocardiography.
NCT04231331 ↗	Ertugliflozin for Functional Mitral Regurgitation	Recruiting	Asan Medical Center	Phase 3	2020-11-04	In patients with heart failure (HF) and left ventricular (LV) dilation, adverse LV remodeling causes tethering of mitral valve (MV) preventing sufficient coaptation of normal leaflets and resulting in functional MR. Because secondary functional MR usually develops as a result of LV dysfunction, guideline-directed medical therapy for HF forms the mainstay of therapy. However, beta blockers, angiotensin-converting-enzyme (ACE) inhibitors, and angiotensin receptor blockers (ARB) fail to reverse adverse LV remodeling and functional MR, and the morbidity and mortality of patients with functional MR remain high despite standard medical therapy. Randomized trials to explore cardiovascular (CV) benefit of the sodium-glucose co-transporter-2 (SGLT2) inhibitor have been performed and showed a significant reduction on the risk of CV death or hospitalization for HF. However, its effect on cardiac structure and function was not evaluated and further mechanistic studies are needed to interpret beneficial clinical effects of the SGLT2 inhibitors. Based on studies demonstrating SGLT2 inhibitors' favorable effects on LV modeling, investigators hypothesize that SGLT2 inhibitor, ertugliflozin, is effective on improving MR in patients with functional MR secondary to LV dysfunction and try to examine this hypothesis in a multicenter, double-blind, randomized comparison study using echocardiography.

Clinical Trial Conditions for STEGLATRO

Condition Name

Condition Name for STEGLATRO
Intervention	Trials
Renal Hypoxia	1
Cardiac Resynchronization Therapy	1
Renoprotection	1
Diabetic Kidney Disease	1

Condition MeSH

Condition MeSH for STEGLATRO
Intervention	Trials
Diabetes Mellitus, Type 2	2
Diabetes Mellitus	2
Heart Failure	2
Mitral Valve Insufficiency	1

Clinical Trial Locations for STEGLATRO

Trials by Country

Trials by Country for STEGLATRO
Location	Trials
Austria	3
Korea, Republic of	2
Netherlands	1

Clinical Trial Progress for STEGLATRO

Clinical Trial Phase

Clinical Trial Phase for STEGLATRO
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	3

Clinical Trial Status

Clinical Trial Status for STEGLATRO
Clinical Trial Phase	Trials
Recruiting	4

Clinical Trial Sponsors for STEGLATRO

Sponsor Name

Sponsor Name for STEGLATRO
Sponsor	Trials
Klinikum Wiener Neustadt	1
Medical University Innsbruck	1
MSD Korea Ltd.	1

Sponsor Type

Sponsor Type for STEGLATRO
Sponsor	Trials
Other	12
Industry	2

STEGLATRO (ertugliflozin) Clinical Trials Update, Market Analysis, and Projection

Last updated: May 1, 2026

What is STEGLATRO and what is its current evidence base?

STEGLATRO is ertugliflozin, an oral sodium-glucose cotransporter-2 (SGLT2) inhibitor for type 2 diabetes. The pivotal efficacy and cardiovascular outcome program for ertugliflozin is the VERTIS clinical trial program.

Core outcomes from the VERTIS cardiovascular outcomes trial

• Trial: VERTIS CV (NCT01986818)
• Design: Phase 3, randomized, double-blind, placebo-controlled, event-driven cardiovascular outcomes
• Population: Type 2 diabetes with established cardiovascular disease or high cardiovascular risk
• Primary endpoint: Major adverse cardiovascular events (MACE: CV death, nonfatal MI, nonfatal stroke)
• Key results (CV safety and efficacy):
  • VERTIS CV met noninferiority for MACE vs placebo.
  • The program supports CV safety labeling consistent with SGLT2 inhibitor class outcomes described in FDA communications for this drug.

What clinical trials are most relevant now?

STEGLATRO’s clinically relevant pipeline activity is largely shaped by (1) ongoing post-marketing and long-term follow-up studies, and (2) expansion into combination regimens and broader-label evidence under the class-level CV and renal outcome framework.

Trial map by evidence type (VERTIS program and major derivative studies)

• Cardiovascular outcomes: VERTIS CV (ERTUGLIFLOZIN vs placebo)
• Renal and composite kidney endpoints: VERTIS DK and related renal-focused analyses within the VERTIS framework (endpoint-driven analyses aligned to kidney disease progression constructs used across the SGLT2 class)
• Glycemic efficacy and safety: VERTIS Met (ertugliflozin + metformin), VERTIS SITA (ertugliflozin + sitagliptin), VERTIS Factorial/other add-on and monotherapy studies (placebo-controlled and active-comparator designs typical of the SGLT2 class)

Regulatory and clinical takeaways

• The commercial positioning of STEGLATRO in the market is anchored to demonstrated CV safety/noninferiority and the SGLT2 renal and heart failure evidence that became standard across the class during and after the VERTIS program maturity period.
• Since SGLT2 adoption in cardiometabolic care follows a class pattern, the drug’s market performance depends less on incremental clinical trial “breakthrough” and more on label breadth, guideline inclusion, payer coverage, and acquisition cost versus competing agents.

What is the STEGLATRO market today and how does it compare to competitors?

STEGLATRO competes in the oral SGLT2 inhibitor market against:

• empagliflozin (Jardiance)
• dapagliflozin (Farxiga)
• canagliflozin (Invokana)

Competitive market structure

• The SGLT2 segment has two dominant drivers:
  1. guideline-driven preference for agents with strong cardiorenal outcomes,
  2. payer formulary placement based on WAC-to-outcome value and contracting.

Positioning implications for ertugliflozin

• STEGLATRO benefits from the SGLT2 class effect on CV and renal risk constructs used in practice, but market share tends to follow the strongest payer and guideline momentum around the leading agents (Jardiance and Farxiga) in many geographies.
• The likely “price and access” gap versus top-selling SGLT2 brands is the main constraint on scale, unless offset by contracting strength or specific payer incentives for preferred formulary use.

How does STEGLATRO’s clinical differentiation affect commercial uptake?

Clinical differentiation for SGLT2 inhibitors increasingly comes from:

• demonstrated outcomes in dedicated CVOT and kidney-focused analyses,
• label language (heart failure, CKD) and eligibility definitions,
• and the ability to fit prescribing behavior within comorbidity-first pathways.

For STEGLATRO:

• The clinical evidence foundation is built on VERTIS CV and related VERTIS outcomes analyses (cardiovascular safety and outcomes positioning) as reported in FDA-facing and trial registry records for the VERTIS program (e.g., VERTIS CV, NCT01986818).
• Where competing agents have clearer or earlier uptake in payer formularies due to perceived strength or broader uptake in guideline pathways, STEGLATRO’s growth depends on continued contracting and uptake within diabetes-centered and cardiorenal comorbidity care streams.

What is the market projection for STEGLATRO over the next 5 years?

A projection requires a baseline (units/revenue or category share), growth rate, and competitive capture assumptions. The prompt does not include STEGLATRO-specific sales baselines, unit trends, or payer/channel data necessary to produce a complete, accurate numeric forecast.

Because those inputs are not provided here, a numeric STEGLATRO forecast would not be complete or accurate. Under the operating constraint, no forecast numbers are issued.

What can be stated as decision-grade directional drivers without assigning a numeric model:

• Growth headwinds:
  • high brand competition among SGLT2 inhibitors with entrenched payer preference for the top two brands in many formularies,
  • price pressure and contracting volatility within Medicare Part D and commercial plans,
  • guideline and formulary consolidation toward fewer preferred agents.
• Growth tailwinds:
  • continued conversion of diabetes patients into cardiorenal risk workflows,
  • potential formulary wins in health systems using class-based outcome pathways where STEGLATRO is placed as a preferred option,
  • combination strategy and persistence-based adherence within oral SGLT2 regimens.

What should R&D and investment teams monitor?

1. Label and outcome evidence delivery
   • Continued publication and regulatory updates around VERTIS-derived kidney and cardiovascular endpoint constructs, and how payers interpret label eligibility categories.
2. Payer formulary mechanics
   • Movement between “preferred” and “non-preferred” tiers; step edits; prior authorization patterns for SGLT2s.
3. Competitive contracting
   • Net pricing versus Jardiance and Farxiga after rebates and managed care contracting.
4. Real-world persistence and switching
   • Switch rates after acute events (HF hospitalization, CKD progression) that drive post-index changes among SGLT2 brands.

Key Takeaways

• STEGLATRO is ertugliflozin and its clinical evidence anchor is the VERTIS outcomes program, with VERTIS CV (NCT01986818) as the primary cardiovascular outcomes trial.
• Market performance is driven primarily by payer formulary position and contracting, not by major incremental trial breakthroughs at this stage of the class.
• A numeric 5-year STEGLATRO projection cannot be produced from the provided information while meeting completeness and accuracy requirements.

FAQs

1) What trial established STEGLATRO’s cardiovascular outcomes position?
VERTIS CV (NCT01986818).

2) What drug class is STEGLATRO in?
SGLT2 inhibitor (sodium-glucose cotransporter-2).

3) Why does STEGLATRO’s market uptake depend on factors beyond clinical trial results?
Because SGLT2 inhibitors compete heavily on payer placement, net pricing, and formulary tiering once class-level outcomes are established.

4) Is STEGLATRO currently considered a standard-of-care option for type 2 diabetes with CV risk?
It is positioned within the SGLT2 CV safety and outcomes framework supported by VERTIS evidence.

5) Can a numeric market forecast be given without baseline sales and channel data?
No. A forecast would not be complete or accurate without those inputs.

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References

[1] ClinicalTrials.gov. VERTIS CV (Cardiovascular Outcomes Trial). NCT01986818. https://clinicaltrials.gov/ct2/show/NCT01986818
[2] FDA. (Trial and label-related communications for ertugliflozin and SGLT2 CV outcomes context are reflected in regulatory materials associated with the VERTIS program). https://www.fda.gov/