Skip to content
GLP-1 Desk
Menu

Evidence review

GLP-1, the Heart and the Kidneys: The SELECT and FLOW Trials

Semaglutide's two newest FDA indications aren't about weight loss at all — they're for reducing heart-attack, stroke and kidney-disease risk directly.

By The Desk, Provider Intelligence Desk
On this page

The Desk's #1 pick

CoreAge Rx

A

The Desk's top dispatch: flat all-in pricing, both molecules, all 50 states — no teaser-rate traps.

Check availability
Semaglutide
$149/mo
Tirzepatide
$349/mo
Coverage
All 50 states
Access
Compounded

Advertising disclosure · we may earn a commission at no extra cost to you. It never changes what we write about a product — an unflattering finding on a paying provider stays in.

Also on the board

Strut Health

B+

The same molecule as a lozenge or an injection at the same price — the only place on this board where the needle is genuinely optional.

Check Strut Health availability

Weight loss is not the only thing semaglutide is now FDA-approved to do. Two large outcomes trials, run specifically to test cardiovascular and kidney endpoints rather than the number on the scale, led to two separate label expansions — and both matter regardless of how much weight a patient loses.

SELECT: cardiovascular risk, independent of diabetes

The SELECT trial enrolled 17,604 adults with established cardiovascular disease and overweight or obesity, but without diabetes — a population outside the traditional GLP-1 diabetes-outcomes evidence base. Over a median follow-up beyond three years, semaglutide reduced the composite rate of cardiovascular death, non-fatal heart attack, or non-fatal stroke to 6.5%, versus 8.0% on placebo1. In March 2024, the FDA approved Wegovy specifically to reduce this risk in adults with cardiovascular disease and obesity or overweight — the first weight-management drug ever approved for that purpose2.

FLOW: kidney outcomes in type 2 diabetes

The FLOW trial studied a different population: 3,533 adults with type 2 diabetes and chronic kidney disease, on top of standard care. Semaglutide reduced the risk of the trial's composite kidney and cardiovascular-death outcome, with a hazard ratio of 0.76 — a 24% relative risk reduction3. In January 2025, the FDA approved Ozempic to reduce the risk of sustained kidney function decline, kidney failure, and cardiovascular death specifically in adults with type 2 diabetes and chronic kidney disease4.

Why these are two separate approvals, not one

Ozempic and Wegovy are the same molecule under different FDA approvals to begin with — see Ozempic vs Wegovy for that distinction. SELECT and FLOW extend that split further: Wegovy's cardiovascular claim is approved for a non-diabetic population with existing heart disease, while Ozempic's kidney claim is approved for a diabetic population with chronic kidney disease. Neither trial's result transfers to the other drug's label, and neither transfers to tirzepatide, which was not the molecule studied in either trial.

What this means beyond the prescription pad

Both trials are evidence that at least one GLP-1 molecule has measurable effects on hard outcomes — death, heart attack, stroke, kidney failure — that are not fully explained by weight loss alone; both trials adjusted for and discussed effects beyond the weight change itself13. That is a meaningfully different claim than "this drug helps you lose weight," and it is part of why these two approvals specifically cite outcomes data rather than a weight-loss percentage.

Related reading

For the full molecule-level picture, see GLP-1 side effects for the safety data behind both drugs, and semaglutide vs tirzepatide for how the two GLP-1 molecules compare on the weight-loss evidence these outcomes trials build on. If you're choosing a provider with either of these conditions in mind, confirm brand-name access on the best semaglutide providers board rather than assuming a compounded filing carries the same FDA-reviewed indication. The rest of the Desk's sourced evidence is in the research library.

Frequently asked questions

Does semaglutide reduce heart attack and stroke risk?

In the SELECT trial — 17,604 adults with cardiovascular disease and obesity or overweight but no diabetes — semaglutide reduced the composite rate of cardiovascular death, non-fatal heart attack or non-fatal stroke to 6.5%, versus 8.0% on placebo. The FDA approved Wegovy for this specific use in March 2024.

Does semaglutide help kidney disease?

In the FLOW trial — 3,533 adults with type 2 diabetes and chronic kidney disease — semaglutide reduced the risk of the trial's composite kidney and cardiovascular-death outcome by 24% (hazard ratio 0.76). The FDA approved Ozempic for this use in January 2025.

Does tirzepatide have the same heart and kidney approvals?

No. SELECT and FLOW both studied semaglutide specifically, not tirzepatide, and neither approval extends to Zepbound's label.

Are these benefits separate from weight loss?

Both trials specifically examined outcomes — death, heart attack, stroke, kidney failure — as a distinct question from the weight-loss percentage, and both discussed effects that were not fully explained by weight change alone.

References

  1. Lincoff AM, Brown-Frandsen K, Colhoun HM, et al. (2023). Semaglutide and Cardiovascular Outcomes in Obesity without Diabetes (SELECT). New England Journal of Medicine. https://pubmed.ncbi.nlm.nih.gov/37952131/
  2. U.S. Food and Drug Administration (2024). FDA Approves First Treatment to Reduce Risk of Serious Heart Problems Specifically in Adults with Obesity or Overweight. FDA.gov, Press Announcements. https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-reduce-risk-serious-heart-problems-specifically-adults-obesity-or
  3. Perkovic V, Tuttle KR, Rossing P, et al. (2024). Effects of Semaglutide on Chronic Kidney Disease in Patients with Type 2 Diabetes (FLOW). New England Journal of Medicine. https://pubmed.ncbi.nlm.nih.gov/38785209/
  4. U.S. Food and Drug Administration (2025). Ozempic (semaglutide) injection — Supplemental Approval Letter, Chronic Kidney Disease Indication. Drugs@FDA. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/209637Orig1s025ltr.pdf

Medical disclaimer: This content is for general educational purposes only and is not medical advice, diagnosis, or treatment. Always consult a licensed healthcare professional before starting, stopping, or changing any treatment.

Continue reading