---
title: "Cardiovascular safety of oral orforglipron versus insulin glargine in T2D at increased CV risk (AC"
id: "pubmed-42815506"
canonical_url: "https://medichelpline.com/clinical-feed/pubmed-42815506"
content_type: "clinical_feed_article"
specialty: "Endocrinology"
source_name: "PubMed / NCBI"
source_url: "https://pubmed.ncbi.nlm.nih.gov/42815506/"
doi: "10.1016/S0140-6736(26)01865-9"
published_at: "2026-10-17T00:00:00.000Z"
evidence_level: "Journal Article"
license: "CC-BY-NC-4.0 / Informational Use"
---
# Cardiovascular safety of oral orforglipron versus insulin glargine in T2D at increased CV risk (AC
## Provenance & Clinical Metadata
- **Canonical URL:** https://medichelpline.com/clinical-feed/pubmed-42815506
- **Specialty:** [Endocrinology](https://medichelpline.com/clinical-feed/endocrinology.md)
- **Primary Source:** PubMed / NCBI
- **Source URL:** [Original Journal Publication](https://pubmed.ncbi.nlm.nih.gov/42815506/)
- **DOI:** [10.1016/S0140-6736(26)01865-9](https://doi.org/10.1016%2FS0140-6736(26)01865-9)
- **Published At:** 2026-10-17T00:00:00.000Z
- **Evidence Rating:** Journal Article
## Executive GIST (TL;DR)
- The ACHIEVE-4 trial compared oral **orforglipron** with injectable **insulin glargine** for cardiovascular safety in adults with type 2 diabetes at increased cardiovascular risk. - Phase 3, event-driven, randomised, open-label, active-comparator design conducted across 317 sites in 16 countries; registered as NCT05803421. - Eligible participants had HbA1c 7.0–10.5% and BMI ≥25 kg/m2, and were on up to three oral glucose-lowering drugs (metformin, a sulfonylurea, and/or an SGLT2 inhibitor). - Randomisation was 1:1 to oral orforglipron (maximum tolerated dose up to a 36 mg capsule, equivalent to a 17.2 mg tablet) or titrated daily insulin glargine. - Primary endpoint: time to first occurrence of four-component major adverse cardiovascular events (**MACE-4**): cardiovascular death, non-fatal MI, non-fatal stroke, or hospitalisation for unstable angina. - Non-inferiority margin prespecified: upper bound of two-sided 95% CI for HR 2 year) follow-up data in the abstract.
## Clinical Analysis & Structured Key Points
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Epub 2026 Sep 30. # Cardiovascular safety of orforglipron versus insulin glargine in adults with type 2 diabetes at increased cardiovascular risk (ACHIEVE-4): a phase 3, event-driven, randomised, open-label, non-inferiority, active comparator trial [Klara R Klein](https://pubmed.ncbi.nlm.nih.gov/?term=Klein+KR&cauthor_id=42815506)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42815506/#full-view-affiliation-1 "Department of Medicine, University of North Carolina School of Medicine, Chapel Hill, NC, USA. Electronic address: klara_klein@med.unc.edu."), [Carol Wysham](https://pubmed.ncbi.nlm.nih.gov/?term=Wysham+C&cauthor_id=42815506)[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42815506/#full-view-affiliation-2 "Division of Endocrinology and Diabetes, Multicare/Rockwood Clinic, Spokane, WA, USA."), [Katherine R Tuttle](https://pubmed.ncbi.nlm.nih.gov/?term=Tuttle+KR&cauthor_id=42815506)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42815506/#full-view-affiliation-3 "Providence Medical Research Center, Providence Inland Northwest Health, Spokane, WA, USA; Nephrology Division and Kidney Research Institute, Department of Medicine, University of Washington School of Medicine, Seattle, WA, USA."), [Melanie J Davies](https://pubmed.ncbi.nlm.nih.gov/?term=Davies+MJ&cauthor_id=42815506)[ 4 ](https://pubmed.ncbi.nlm.nih.gov/42815506/#full-view-affiliation-4 "Diabetes Research Centre, University of Leicester, Leicester NIHR Biomedical Research Centre, Leicester, UK."), [David Cox](https://pubmed.ncbi.nlm.nih.gov/?term=Cox+D&cauthor_id=42815506)[ 5 ](https://pubmed.ncbi.nlm.nih.gov/42815506/#full-view-affiliation-5 "Eli Lilly and Company, Indianapolis, IN, USA."), [Jiaxun Chen](https://pubmed.ncbi.nlm.nih.gov/?term=Chen+J&cauthor_id=42815506)[ 5 ](https://pubmed.ncbi.nlm.nih.gov/42815506/#full-view-affiliation-5 "Eli Lilly and Company, Indianapolis, IN, USA."), [Wen-Shuo Wu](https://pubmed.ncbi.nlm.nih.gov/?term=Wu+WS&cauthor_id=42815506)[ 5 ](https://pubmed.ncbi.nlm.nih.gov/42815506/#full-view-affiliation-5 "Eli Lilly and Company, Indianapolis, IN, USA."), [Max Denning](https://pubmed.ncbi.nlm.nih.gov/?term=Denning+M&cauthor_id=42815506)[ 5 ](https://pubmed.ncbi.nlm.nih.gov/42815506/#full-view-affiliation-5 "Eli Lilly and Company, Indianapolis, IN, USA."), [Rong Liu](https://pubmed.ncbi.nlm.nih.gov/?term=Liu+R&cauthor_id=42815506)[ 5 ](https://pubmed.ncbi.nlm.nih.gov/42815506/#full-view-affiliation-5 "Eli Lilly and Company, Indianapolis, IN, USA."), [Lisa Ludwig](https://pubmed.ncbi.nlm.nih.gov/?term=Ludwig+L&cauthor_id=42815506)[ 5 ](https://pubmed.ncbi.nlm.nih.gov/42815506/#full-view-affiliation-5 "Eli Lilly and Company, Indianapolis, IN, USA."), [Eric R Meskimen](https://pubmed.ncbi.nlm.nih.gov/?term=Meskimen+ER&cauthor_id=42815506)[ 5 ](https://pubmed.ncbi.nlm.nih.gov/42815506/#full-view-affiliation-5 "Eli Lilly and Company, Indianapolis, IN, USA.") Affiliations Expand ### Affiliations * 1 Department of Medicine, University of North Carolina School of Medicine, Chapel Hill, NC, USA. Electronic address: klara_klein@med.unc.edu. * 2 Division of Endocrinology and Diabetes, Multicare/Rockwood Clinic, Spokane, WA, USA. * 3 Providence Medical Research Center, Providence Inland Northwest Health, Spokane, WA, USA; Nephrology Division and Kidney Research Institute, Department of Medicine, University of Washington School of Medicine, Seattle, WA, USA. * 4 Diabetes Research Centre, University of Leicester, Leicester NIHR Biomedical Research Centre, Leicester, UK. * 5 Eli Lilly and Company, Indianapolis, IN, USA. * PMID: **42815506** * DOI: [ 10.1016/S0140-6736(26)01865-9 ](https://doi.org/10.1016/s0140-6736\(26\)01865-9) Item in Clipboard Clinical Trial # Cardiovascular safety of orforglipron versus insulin glargine in adults with type 2 diabetes at increased cardiovascular risk (ACHIEVE-4): a phase 3, event-driven, randomised, open-label, non-inferiority, active comparator trial Klara R Klein et al. Lancet. 2026. Show details Display options Display options Format Abstract PubMed PMID Lancet Actions * [ Search in PubMed ](https://pubmed.ncbi.nlm.nih.gov/?term=%22Lancet%22%5Bjour%5D&sort=date&sort_order=desc) * [ Search in NLM Catalog ](https://www.ncbi.nlm.nih.gov/nlmcatalog?term=%22Lancet%22%5BTitle+Abbreviation%5D) * [ Add to Search ](https://pubmed.ncbi.nlm.nih.gov/42815506/) . 2026 Oct 17;408(10564):1557-1570. doi: 10.1016/S0140-6736(26)01865-9. Epub 2026 Sep 30. ### Authors [Klara R Klein](https://pubmed.ncbi.nlm.nih.gov/?term=Klein+KR&cauthor_id=42815506)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42815506/#short-view-affiliation-1 "Department of Medicine, University of North Carolina School of Medicine, Chapel Hill, NC, USA. Electronic address: klara_klein@med.unc.edu."), [Carol Wysham](https://pubmed.ncbi.nlm.nih.gov/?term=Wysham+C&cauthor_id=42815506)[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42815506/#short-view-affiliation-2 "Division of Endocrinology and Diabetes, Multicare/Rockwood Clinic, Spokane, WA, USA."), [Katherine R Tuttle](https://pubmed.ncbi.nlm.nih.gov/?term=Tuttle+KR&cauthor_id=42815506)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42815506/#short-view-affiliation-3 "Providence Medical Research Center, Providence Inland Northwest Health, Spokane, WA, USA; Nephrology Division and Kidney Research Institute, Department of Medicine, University of Washington School of Medicine, Seattle, WA, USA."), [Melanie J Davies](https://pubmed.ncbi.nlm.nih.gov/?term=Davies+MJ&cauthor_id=42815506)[ 4 ](https://pubmed.ncbi.nlm.nih.gov/42815506/#short-view-affiliation-4 "Diabetes Research Centre, University of Leicester, Leicester NIHR Biomedical Research Centre, Leicester, UK."), [David Cox](https://pubmed.ncbi.nlm.nih.gov/?term=Cox+D&cauthor_id=42815506)[ 5 ](https://pubmed.ncbi.nlm.nih.gov/42815506/#short-view-affiliation-5 "Eli Lilly and Company, Indianapolis, IN, USA."), [Jiaxun Chen](https://pubmed.ncbi.nlm.nih.gov/?term=Chen+J&cauthor_id=42815506)[ 5 ](https://pubmed.ncbi.nlm.nih.gov/42815506/#short-view-affiliation-5 "Eli Lilly and Company, Indianapolis, IN, USA."), [Wen-Shuo Wu](https://pubmed.ncbi.nlm.nih.gov/?term=Wu+WS&cauthor_id=42815506)[ 5 ](https://pubmed.ncbi.nlm.nih.gov/42815506/#short-view-affiliation-5 "Eli Lilly and Company, Indianapolis, IN, USA."), [Max Denning](https://pubmed.ncbi.nlm.nih.gov/?term=Denning+M&cauthor_id=42815506)[ 5 ](https://pubmed.ncbi.nlm.nih.gov/42815506/#short-view-affiliation-5 "Eli Lilly and Company, Indianapolis, IN, USA."), [Rong Liu](https://pubmed.ncbi.nlm.nih.gov/?term=Liu+R&cauthor_id=42815506)[ 5 ](https://pubmed.ncbi.nlm.nih.gov/42815506/#short-view-affiliation-5 "Eli Lilly and Company, Indianapolis, IN, USA."), [Lisa Ludwig](https://pubmed.ncbi.nlm.nih.gov/?term=Ludwig+L&cauthor_id=42815506)[ 5 ](https://pubmed.ncbi.nlm.nih.gov/42815506/#short-view-affiliation-5 "Eli Lilly and Company, Indianapolis, IN, USA."), [Eric R Meskimen](https://pubmed.ncbi.nlm.nih.gov/?term=Meskimen+ER&cauthor_id=42815506)[ 5 ](https://pubmed.ncbi.nlm.nih.gov/42815506/#short-view-affiliation-5 "Eli Lilly and Company, Indianapolis, IN, USA.") ### Affiliations * 1 Department of Medicine, University of North Carolina School of Medicine, Chapel Hill, NC, USA. Electronic address: klara_klein@med.unc.edu. * 2 Division of Endocrinology and Diabetes, Multicare/Rockwood Clinic, Spokane, WA, USA. * 3 Providence Medical Research Center, Providence Inland Northwest Health, Spokane, WA, USA; Nephrology Division and Kidney Research Institute, Department of Medicine, University of Washington School of Medicine, Seattle, WA, USA. * 4 Diabetes Research Centre, University of Leicester, Leicester NIHR Biomedical Research Centre, Leicester, UK. * 5 Eli Lilly and Company, Indianapolis, IN, USA. * PMID: **42815506** * DOI: [ 10.1016/S0140-6736(26)01865-9 ](https://doi.org/10.1016/s0140-6736\(26\)01865-9) Item in Clipboard Cite Display options Display options Format Abstract PubMed PMID Linked Discoveries ## Erratum in * [ Department of Error. ](https://pubmed.ncbi.nlm.nih.gov/42880309/) [No authors listed] [No authors listed] Lancet. 2026 Oct 17;408(10564):1556. doi: 10.1016/S0140-6736(26)02055-6. Lancet. 2026. PMID: 42880309 No abstract available. ## Abstract **Background:** Orforglipron is an oral, non-peptide GLP-1 receptor agonist. While some peptide GLP-1 receptor agonists have established cardiovascular benefit, the cardiovascular safety of non-peptide GLP-1 receptor agonists has not been studied. This study aimed to compare the effect of orforglipron with insulin glargine on the incidence of major adverse cardiovascular events in individuals with type 2 diabetes and obesity or overweight who are at increased risk for cardiovascular events. **Methods:** This event-driven, phase 3, multicentre, randomised, open-label, active comparator, parallel-group study was conducted in 317 sites across 16 countries and territories. Adults with type 2 diabetes at increased cardiovascular risk with glycated haemoglobin (HbA1c) concentrations between 7·0% and 10·5% (53-91 mmol/mol) and a BMI of 25 kg/m2 or more, treated with up to three glucose-lowering medications (metformin, a sulfonylurea, and/or an SGLT2 inhibitor), were randomly assigned (1:1) to oral orforglipron maximum tolerated dose (up to 36 mg capsule [equivalent to 17·2 mg tablet]) or injectable titrated insulin glargine, each administered once daily. All participants had established cardiovascular or chronic kidney disease. The primary outcome was time to occurrence of four-component major adverse cardiovascular events (MACE-4), including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or hospitalisation for unstable angina. Non-inferiority of orforglipron to insulin glargine was declared if the upper limit of the two-sided 95% CI for the hazard ratio (HR; orforglipron vs insulin glargine) was less than 1·8. The primary endpoint and other safety endpoints were assessed in all participants who took at least one dose of assigned treatment using all datapoints from baseline until withdrawal or study completion, regardless of treatment adherence. This trial was registered on ClinicalTrials.gov ([NCT05803421](http://clinicaltrials.gov/show/NCT05803421 "See in ClinicalTrials.gov")) and is completed. **Findings:** Between May 1, 2023, and Sept 5, 2024, 2749 participants were randomly assigned (1371 to orforglipron and 1378 to insulin glargine). 1032 (38%) participants were female and 1717 (62·5%) male. 2362 (85·9%) participants had established cardiovascular disease and 1033 (37·6%) had chronic kidney disease. Mean baseline age, HbA1c, and BMI were 63·1 years (SD 9·9), 8·2% (1·0), and 33 kg/m2 (6·2), respectively. Over a median follow-up of 2 years, the primary outcome occurred in 57 (4·2%) of 1358 orforglipron participants and 67 (5·0%) of 1343 insulin glargine participants, showing non-inferiority to insulin glargine for MACE-4 (HR 0·84; 95% CI 0·59-1·20; p<0·0001 for non-inferiority). Gastrointestinal adverse events were reported in 851 (62·1%) of 1371 orforglipron participants and 193 (14·2%) of 1355 insulin glargine participants; clinically significant or severe hypoglycaemia (glucose <3 mmol/L [54 mg/dL]) occurred in 93 (6·8%) of 1371 orforglipron participants and 260 (19·2%) of 1355 insulin glargine participants. 62 deaths were reported during the study: 19 (1·4%) of 1371 participants receiving orforglipron and 43 (3·2%) of 1355 participants receiving insulin glargine; all deaths except one (in the insulin glargine group) were deemed unrelated to treatment. **Interpretation:** In people with type 2 diabetes at increased cardiovascular risk, the cardiovascular safety of orforglipron was confirmed by demonstrating non-inferiority to insulin glargine for MACE-4. Gastrointestinal adverse events were the most frequent adverse event and most common reason for orforglipron treatment discontinuation with orforglipron, while clinically significant hypoglycaemia occurred less frequently with orforglipron than with insulin glargine. These findings support orforglipron as a potential once-daily, oral treatment option with established cardiovascular safety in people with type 2 diabetes and increased cardiovascular risk. **Funding:** Eli Lilly and Company. Copyright © 2026 Elsevier Ltd. All rights reserved, including those for text and data mining, AI training, and similar technologies. [PubMed Disclaimer](https://pubmed.ncbi.nlm.nih.gov/disclaimer/) ## Conflict of interest statement Declaration of interests KRK has received advisory or consulting fees support from Antag Therapeutics, Corxel, Eli Lilly and Company, Metsera, Novo Nordisk, Roche Pharmaceuticals, Vertex Pharmaceuticals, and vTv Therapeutics; and has received research-related contracts (paid to the institution) from Bayer, Boehringer Ingelheim, Carmot, Diasome, Eli Lilly and Company, Gentibio, Novo Nordisk, Rhythm Pharmaceuticals, Roche Pharmaceuticals, and vTv Therapeutics. CW reports receiving research funding from Eli Lilly, Novo Nordisk, and AbbVie; consultancy fees from Abbott Diabetes, Eli Lilly, Novo Nordisk, and Medscape; fees for speaking from Eli Lilly and Novo Nordisk; and currently serves as Chair of the Board of Trustees for the Hormone Foundation. KRT is supported by US federal research grants from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Heart,
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