Nature Medicine May 25, 2024

Long-term kidney outcomes of semaglutide in obesity and cardiovascular disease in the SELECT trial

Helen M Colhoun, Ildiko Lingvay, Paul M Brown, et al.

Bottom Line

In a pre-specified secondary analysis of the SELECT trial, once-weekly subcutaneous semaglutide 2.4 mg significantly reduced the risk of a composite kidney endpoint by 22% and slowed eGFR decline in non-diabetic adults with overweight or obesity and established cardiovascular disease.

Key Findings

1. The pre-specified main composite kidney endpoint occurred in 1.8% of the semaglutide group compared to 2.2% of the placebo group, reflecting a significant 22% risk reduction (HR 0.78; 95% CI 0.63-0.96; P=0.02).
2. At 104 weeks, the overall treatment benefit for estimated glomerular filtration rate (eGFR) was 0.75 ml/min/1.73 m² (95% CI 0.43-1.06; P<0.001) in favor of semaglutide.
3. The eGFR preservation benefit at 104 weeks was more pronounced in patients with pre-existing renal impairment (baseline eGFR <60 ml/min/1.73 m²), showing a treatment difference of 2.19 ml/min/1.73 m² (95% CI 1.00-3.38; P<0.001).
4. The reduction in the main composite kidney endpoint was largely driven by a prevention of persistent macroalbuminuria and fewer persistent ≥50% reductions in eGFR.

Study Design

Design
Secondary Analysis
Double-Blind
Sample
17,604
Patients
Duration
40 mo
Median
Setting
Multinational
Population Adults aged ≥45 years with overweight or obesity (BMI ≥27 kg/m²) and established cardiovascular disease, without diabetes.
Intervention Once-weekly subcutaneous semaglutide 2.4 mg
Comparator Matching placebo
Outcome Pre-specified main composite kidney endpoint: death from kidney disease, initiation of chronic kidney replacement therapy, onset of persistent eGFR <15 ml/min/1.73 m², persistent ≥50% reduction in eGFR, or onset of persistent macroalbuminuria.

Study Limitations

As a secondary analysis, the trial was not primarily powered for kidney outcomes, resulting in a low absolute number of hard end-stage renal events (e.g., kidney failure or renal death).
The study population was restricted to patients with established cardiovascular disease, limiting generalizability to obese individuals without pre-existing clinical cardiovascular disease.
Individuals with diabetes were excluded, meaning these specific results address non-diabetic nephropathy, although other dedicated trials (like FLOW) address diabetic populations.
The mean follow-up period of approximately 40 months may not be long enough to capture the full, lifetime trajectory of chronic kidney disease progression or the delay to dialysis.

Clinical Significance

This analysis establishes that the cardio-metabolic benefits of GLP-1 receptor agonists extend to renal protection even in the absence of diabetes. For patients with obesity and cardiovascular disease, semaglutide offers a disease-modifying approach that mitigates obesity-associated chronic kidney disease progression, emphasizing the renoprotective value of metabolic and weight optimization.

Historical Context

Historically, major trials demonstrating pharmacological renal protection have focused almost exclusively on populations with diabetic kidney disease (e.g., using RAAS inhibitors, SGLT2 inhibitors, or non-steroidal MRAs). While the primary SELECT trial broke ground by showing semaglutide reduced major adverse cardiovascular events (MACE) in a non-diabetic obese population, this secondary analysis bridged a critical gap in nephrology. Released concurrently with the FLOW trial—which proved primary kidney benefits of semaglutide in diabetic kidney disease—this SELECT analysis confirms that GLP-1 receptor agonists exert broad renoprotective effects that are at least partially independent of glucose-lowering.

Guided Discussion

High-yield insights from every perspective

Med Student
Medical Student

Given that the patients in the SELECT trial were non-diabetic, what are the proposed mechanisms by which semaglutide confers kidney protection and slows eGFR decline independent of glycemic control?

Key Response

This question tests foundational knowledge of the pleiotropic effects of GLP-1 receptor agonists. In the absence of hyperglycemia, semaglutide's nephroprotective mechanisms include the reduction of systemic inflammation, improvement in endothelial function, and reduction of obesity-related glomerular hyperfiltration through weight loss. Additionally, GLP-1 RAs may inhibit proximal tubular sodium reabsorption via NHE3, leading to increased macula densa sodium delivery and afferent arteriolar vasoconstriction via tubuloglomerular feedback, which reduces intraglomerular pressure.

Resident
Resident

A 55-year-old patient with obesity (BMI 34), a prior myocardial infarction, and no diabetes presents with an eGFR of 55 mL/min/1.73m2. Based on the SELECT trial findings, how would you incorporate semaglutide into their management, and what specific clinical monitoring would you prioritize?

Key Response

This addresses clinical application and patient management. The resident should recognize that semaglutide 2.4 mg is indicated for secondary CV prevention in this patient, with the added benefit of slowing eGFR decline as per SELECT. Management involves starting semaglutide while actively monitoring for gastrointestinal side effects (nausea, vomiting, diarrhea) that could lead to acute volume depletion and acute kidney injury, a critical consideration in a patient with pre-existing stage 3 CKD.

Fellow
Fellow

How does the initial eGFR trajectory observed with semaglutide in the SELECT population compare to the hemodynamic 'dip' typically seen with SGLT2 inhibitors, and how should this influence the strategy for combining these agents in non-diabetic patients with structural kidney disease?

Key Response

This requires nuanced subspecialty knowledge. Fellows must differentiate between the pronounced acute hemodynamic eGFR dip of SGLT2 inhibitors (driven by strong afferent vasoconstriction) and the eGFR trajectory of semaglutide, which typically shows a much milder or absent acute dip but a gradual slowing of long-term decline. Understanding these distinct profiles helps nephrology/cardiology fellows safely sequence or combine these disease-modifying therapies without causing alarming acute drops in kidney function.

Attending
Attending

The SELECT trial expands the nephroprotective role of GLP-1 RAs to a non-diabetic population. How does this shift our historical paradigm of treating 'obesity-related glomerulopathy', and how do we prioritize GLP-1 RAs versus RAAS blockade in a normotensive patient with severe obesity and declining eGFR?

Key Response

This explores practice-changing implications. Historically, RAAS inhibition was the primary pharmacological tool used to blunt hyperfiltration in obesity-related CKD, even in normotensive patients. The SELECT data suggests that directly targeting the underlying adiposity and systemic inflammation with semaglutide offers a profound disease-modifying approach, prompting attendings to reconsider the hierarchy of CKD therapies and potentially position GLP-1 RAs earlier in the treatment algorithm for obesity-related kidney disease.

Scholarly Review

Critical appraisal through the lens of expert reviewers and guideline development

PhD
PhD

Because the kidney outcomes in the SELECT trial were a pre-specified secondary analysis rather than the primary endpoint, how does the hierarchical testing strategy and the low event rate of 'hard' kidney endpoints (like kidney failure) affect the statistical power and interpretation of the 22% risk reduction in the composite kidney endpoint?

Key Response

This targets advanced research methodology. A PhD-level critique must evaluate whether the 22% reduction in the composite endpoint was driven predominantly by less severe surrogate markers (like eGFR decline or new-onset macroalbuminuria) rather than hard endpoints like ESKD. Because it is a secondary analysis in a population with generally preserved baseline kidney function, the study may lack statistical power for isolated hard kidney outcomes, necessitating caution when interpreting the clinical weight of the composite risk reduction.

Journal Editor
Journal Editor

As an editor reviewing this manuscript, how would you challenge the authors to address the extent to which the observed kidney benefits are mediated directly by semaglutide versus indirectly through the substantial weight loss achieved, and why is this methodological distinction critical for the field?

Key Response

This focuses on critical appraisal and threats to validity. A rigorous reviewer would demand a formal mediation analysis to separate the drug's direct renal effects (e.g., anti-inflammatory, endothelial) from the hemodynamic benefits of losing substantial body weight. If the benefit is entirely weight-mediated, any potent weight loss intervention (like bariatric surgery or tirzepatide) might achieve similar outcomes; if direct, it establishes semaglutide as uniquely nephroprotective independent of weight.

Guideline Committee
Guideline Committee

Current KDIGO guidelines strongly recommend GLP-1 RAs for patients with T2D and CKD. Based on the SELECT secondary analysis, should guidelines be updated to grant a specific recommendation for GLP-1 RAs to prevent kidney function decline in non-diabetic CKD patients with obesity, or is a dedicated primary kidney outcome trial required first?

Key Response

This explores evidence grading and guideline formulation. While SELECT is a landmark trial for CV outcomes, the kidney endpoint was secondary. Guideline committees typically require a primary outcome trial (such as the FLOW trial, though FLOW was conducted in T2D) to issue a definitive Class I recommendation for CKD progression. The committee must debate whether a highly significant secondary outcome in a massive CV trial is sufficient evidence to update KDIGO or AHA/ACC guidelines to formally recommend semaglutide for renoprotection in non-diabetic obesity.

Clinical Landscape

Noteworthy Related Trials

2016

SUSTAIN 6

n = 3,297 · NEJM

Tested

Semaglutide 0.5mg or 1.0mg weekly

Population

T2DM patients with high CV risk

Comparator

Placebo

Endpoint

3-point MACE

Key result: Semaglutide significantly reduced the risk of cardiovascular events and showed lower rates of new or worsening nephropathy.
2022

EMPA-KIDNEY

n = 6,609 · NEJM

Tested

Empagliflozin 10mg daily

Population

Patients with chronic kidney disease (with or without T2DM)

Comparator

Placebo

Endpoint

Composite of kidney disease progression or cardiovascular death

Key result: Empagliflozin significantly reduced the risk of kidney disease progression or cardiovascular death across a broad range of patients with CKD, including those without diabetes.
2024

FLOW Trial

n = 3,533 · NEJM

Tested

Semaglutide 1.0mg weekly

Population

T2DM patients with chronic kidney disease

Comparator

Placebo

Endpoint

Composite of major kidney disease events and cardiovascular death

Key result: Semaglutide significantly reduced the risk of clinically important kidney outcomes and death from cardiovascular causes in patients with T2DM and CKD.

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