---
title: "Orforglipron Added to Titrated Insulin Glargine Improves Glycemic Control and Weight in Type 2 Dia"
id: "pubmed-42251769"
canonical_url: "https://medichelpline.com/clinical-feed/pubmed-42251769"
content_type: "clinical_feed_article"
specialty: "Pharmacology"
source_name: "PubMed / NCBI"
source_url: "https://pubmed.ncbi.nlm.nih.gov/42251769/"
doi: "10.1001/jama.2026.9512"
published_at: "2026-08-04T00:00:00.000Z"
evidence_level: "Journal Article"
license: "CC-BY-NC-4.0 / Informational Use"
---
# Orforglipron Added to Titrated Insulin Glargine Improves Glycemic Control and Weight in Type 2 Dia
## Provenance & Clinical Metadata
- **Canonical URL:** https://medichelpline.com/clinical-feed/pubmed-42251769
- **Specialty:** [Pharmacology](https://medichelpline.com/clinical-feed/pharmacology.md)
- **Primary Source:** PubMed / NCBI
- **Source URL:** [Original Journal Publication](https://pubmed.ncbi.nlm.nih.gov/42251769/)
- **DOI:** [10.1001/jama.2026.9512](https://doi.org/10.1001%2Fjama.2026.9512)
- **Published At:** 2026-08-04T00:00:00.000Z
- **Evidence Rating:** Journal Article
## Executive GIST (TL;DR)
- The ACHIEVE-5 trial evaluated oral **orforglipron**, a nonpeptide GLP-1 receptor agonist, added to titrated **insulin glargine** in adults with type 2 diabetes inadequately controlled on basal insulin. - Randomized, double-blind, phase 3 study at 72 sites across the US, Brazil, China, Japan, and Romania from November 10, 2023, to September 15, 2025. - 546 participants were randomized to orforglipron 3 mg (n=137), 12 mg (n=132), 36 mg (n=136), or placebo (n=141), all plus titrated insulin glargine; 507 (92.9%) completed 40 weeks. - Baseline: median age 61 years, mean HbA1c 8.50%, mean BMI 30.8, median diabetes duration 14.6 years. - Primary outcome (week 40): mean HbA1c reductions were -1.58% (3 mg), -1.88% (12 mg), -1.82% (36 mg) vs -0.79% for placebo; all doses were superior to placebo (P < .001). - Key secondary outcomes (including achieving HbA1c <7.0% and ≤6.5%) favored **orforglipron**; all key secondary endpoints were statistically significant vs placebo. - Mean percentage body weight change at week 40: -2.6% (3 mg), -4.8% (12 mg), -5.4% (36 mg) vs +0.2% with placebo. - Most common adverse events were gastrointestinal and generally mild to moderate. No increased risk of clinically significant **hypoglycemia** vs placebo was observed. - Trial registration: ClinicalTrials.gov NCT06109311. Other details such as longer-term outcomes and certain subgroup analyses were not reported in the abstract.
## Clinical Analysis & Structured Key Points
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more resources ](https://pubmed.ncbi.nlm.nih.gov/42251769/#linkout) Title & authors Abstract Conflict of interest statement Comment on Similar articles References Publication types MeSH terms Substances Associated data Related information LinkOut - more resources Clinical Trial JAMA Actions * [ Search in PubMed ](https://pubmed.ncbi.nlm.nih.gov/?term=%22JAMA%22%5Bjour%5D&sort=date&sort_order=desc) * [ Search in NLM Catalog ](https://www.ncbi.nlm.nih.gov/nlmcatalog?term=%22JAMA%22%5BTitle+Abbreviation%5D) * [ Add to Search ](https://pubmed.ncbi.nlm.nih.gov/42251769/) . 2026 Aug 4;336(5):389-399. doi: 10.1001/jama.2026.9512. # Orforglipron Added to Titrated Insulin Glargine in Type 2 Diabetes: The ACHIEVE-5 Randomized Clinical Trial [Francesco Giorgino](https://pubmed.ncbi.nlm.nih.gov/?term=Giorgino+F&cauthor_id=42251769)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42251769/#full-view-affiliation-1 "Department of Regenerative and Precision Medicine and Ionian Area, Section of Internal Medicine, Endocrinology, Andrology, and Metabolic Diseases, University of Bari Aldo Moro, Bari, Italy."), [Sherwin D'Souza](https://pubmed.ncbi.nlm.nih.gov/?term=D%27Souza+S&cauthor_id=42251769)[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42251769/#full-view-affiliation-2 "St Luke's Endocrinology, Boise, Idaho."), [Lisa Ludwig](https://pubmed.ncbi.nlm.nih.gov/?term=Ludwig+L&cauthor_id=42251769)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42251769/#full-view-affiliation-3 "Eli Lilly and Company, Indianapolis, Indiana."), [Arihiro Kiyosue](https://pubmed.ncbi.nlm.nih.gov/?term=Kiyosue+A&cauthor_id=42251769)[ 4 ](https://pubmed.ncbi.nlm.nih.gov/42251769/#full-view-affiliation-4 "Tokyo-Eki Centre-Building Clinic, Tokyo, Japan."), [Hilda Ibriga](https://pubmed.ncbi.nlm.nih.gov/?term=Ibriga+H&cauthor_id=42251769)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42251769/#full-view-affiliation-3 "Eli Lilly and Company, Indianapolis, Indiana."), [Hyungmin Rha](https://pubmed.ncbi.nlm.nih.gov/?term=Rha+H&cauthor_id=42251769)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42251769/#full-view-affiliation-3 "Eli Lilly and Company, Indianapolis, Indiana."), [Max Denning](https://pubmed.ncbi.nlm.nih.gov/?term=Denning+M&cauthor_id=42251769)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42251769/#full-view-affiliation-3 "Eli Lilly and Company, Indianapolis, Indiana."), [Wen-Shuo Wu](https://pubmed.ncbi.nlm.nih.gov/?term=Wu+WS&cauthor_id=42251769)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42251769/#full-view-affiliation-3 "Eli Lilly and Company, Indianapolis, Indiana."), [Laura Fernández Landó](https://pubmed.ncbi.nlm.nih.gov/?term=Fern%C3%A1ndez+Land%C3%B3+L&cauthor_id=42251769)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42251769/#full-view-affiliation-3 "Eli Lilly and Company, Indianapolis, Indiana."), [Janet Tobian](https://pubmed.ncbi.nlm.nih.gov/?term=Tobian+J&cauthor_id=42251769)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42251769/#full-view-affiliation-3 "Eli Lilly and Company, Indianapolis, Indiana.") Affiliations Expand ### Affiliations * 1 Department of Regenerative and Precision Medicine and Ionian Area, Section of Internal Medicine, Endocrinology, Andrology, and Metabolic Diseases, University of Bari Aldo Moro, Bari, Italy. * 2 St Luke's Endocrinology, Boise, Idaho. * 3 Eli Lilly and Company, Indianapolis, Indiana. * 4 Tokyo-Eki Centre-Building Clinic, Tokyo, Japan. * PMID: **42251769** * PMCID: **PMC13244277** (available on 2026-12-07) * DOI: [ 10.1001/jama.2026.9512 ](https://doi.org/10.1001/jama.2026.9512) Item in Clipboard Clinical Trial # Orforglipron Added to Titrated Insulin Glargine in Type 2 Diabetes: The ACHIEVE-5 Randomized Clinical Trial Francesco Giorgino et al. JAMA. 2026. Show details Display options Display options Format Abstract PubMed PMID JAMA Actions * [ Search in PubMed ](https://pubmed.ncbi.nlm.nih.gov/?term=%22JAMA%22%5Bjour%5D&sort=date&sort_order=desc) * [ Search in NLM Catalog ](https://www.ncbi.nlm.nih.gov/nlmcatalog?term=%22JAMA%22%5BTitle+Abbreviation%5D) * [ Add to Search ](https://pubmed.ncbi.nlm.nih.gov/42251769/) . 2026 Aug 4;336(5):389-399. doi: 10.1001/jama.2026.9512. ### Authors [Francesco Giorgino](https://pubmed.ncbi.nlm.nih.gov/?term=Giorgino+F&cauthor_id=42251769)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42251769/#short-view-affiliation-1 "Department of Regenerative and Precision Medicine and Ionian Area, Section of Internal Medicine, Endocrinology, Andrology, and Metabolic Diseases, University of Bari Aldo Moro, Bari, Italy."), [Sherwin D'Souza](https://pubmed.ncbi.nlm.nih.gov/?term=D%27Souza+S&cauthor_id=42251769)[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42251769/#short-view-affiliation-2 "St Luke's Endocrinology, Boise, Idaho."), [Lisa Ludwig](https://pubmed.ncbi.nlm.nih.gov/?term=Ludwig+L&cauthor_id=42251769)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42251769/#short-view-affiliation-3 "Eli Lilly and Company, Indianapolis, Indiana."), [Arihiro Kiyosue](https://pubmed.ncbi.nlm.nih.gov/?term=Kiyosue+A&cauthor_id=42251769)[ 4 ](https://pubmed.ncbi.nlm.nih.gov/42251769/#short-view-affiliation-4 "Tokyo-Eki Centre-Building Clinic, Tokyo, Japan."), [Hilda Ibriga](https://pubmed.ncbi.nlm.nih.gov/?term=Ibriga+H&cauthor_id=42251769)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42251769/#short-view-affiliation-3 "Eli Lilly and Company, Indianapolis, Indiana."), [Hyungmin Rha](https://pubmed.ncbi.nlm.nih.gov/?term=Rha+H&cauthor_id=42251769)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42251769/#short-view-affiliation-3 "Eli Lilly and Company, Indianapolis, Indiana."), [Max Denning](https://pubmed.ncbi.nlm.nih.gov/?term=Denning+M&cauthor_id=42251769)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42251769/#short-view-affiliation-3 "Eli Lilly and Company, Indianapolis, Indiana."), [Wen-Shuo Wu](https://pubmed.ncbi.nlm.nih.gov/?term=Wu+WS&cauthor_id=42251769)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42251769/#short-view-affiliation-3 "Eli Lilly and Company, Indianapolis, Indiana."), [Laura Fernández Landó](https://pubmed.ncbi.nlm.nih.gov/?term=Fern%C3%A1ndez+Land%C3%B3+L&cauthor_id=42251769)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42251769/#short-view-affiliation-3 "Eli Lilly and Company, Indianapolis, Indiana."), [Janet Tobian](https://pubmed.ncbi.nlm.nih.gov/?term=Tobian+J&cauthor_id=42251769)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42251769/#short-view-affiliation-3 "Eli Lilly and Company, Indianapolis, Indiana.") ### Affiliations * 1 Department of Regenerative and Precision Medicine and Ionian Area, Section of Internal Medicine, Endocrinology, Andrology, and Metabolic Diseases, University of Bari Aldo Moro, Bari, Italy. * 2 St Luke's Endocrinology, Boise, Idaho. * 3 Eli Lilly and Company, Indianapolis, Indiana. * 4 Tokyo-Eki Centre-Building Clinic, Tokyo, Japan. * PMID: **42251769** * PMCID: **PMC13244277** (available on 2026-12-07) * DOI: [ 10.1001/jama.2026.9512 ](https://doi.org/10.1001/jama.2026.9512) Item in Clipboard Full text links Cite Display options Display options Format Abstract PubMed PMID ## Abstract **Importance:** The effects of orforglipron, an oral, nonpeptide glucagon-like peptide 1 receptor agonist, added to insulin glargine for treatment of type 2 diabetes have not been described. **Objective:** To assess efficacy and safety of orforglipron added to titrated insulin glargine in adults with type 2 diabetes and inadequate glycemic control. **Design, setting, and participants:** Randomized, double-blind, phase 3 study conducted at 72 sites across the US, Brazil, China, Japan, and Romania between November 10, 2023, and September 15, 2025, in adults with type 2 diabetes taking insulin glargine with or without metformin and/or sodium-glucose cotransporter 2 inhibitors over 40 weeks. **Interventions:** Participants were randomized (1:1:1:1) to receive once-daily 3-mg (n = 137), 12-mg (n = 132), or 36-mg (n = 136) dosages of orforglipron or placebo (n = 141), in addition to titrated insulin glargine. **Main outcomes and measures:** The primary outcome was mean hemoglobin A1c (HbA1c) change from baseline to week 40 (for the 12-mg once daily and 36-mg once daily dosages of orforglipron). Key secondary outcomes were mean HbA1c change from baseline (for the 3-mg once daily dosage of orforglipron), proportion of participants achieving HbA1c targets of lower than 7.0% and 6.5% or lower, and mean body weight change and percentage change from baseline to week 40. **Results:** Among 546 randomized participants (median age, 61.0 [IQR, 26-95] years; 52.9% male; median duration of type 2 diabetes, 14.6 [IQR, 0.1-40.7] years; mean HbA1c, 8.50% [SD, 0.95%]; mean body mass index, 30.8 [SD, 6.1]), 507 (92.9%) completed the trial. At week 40, the mean changes from baseline in HbA1c were -1.58%, -1.88%, and -1.82% with orforglipron, 3 mg, 12 mg, and 36 mg once daily, respectively, vs -0.79% with placebo. Each dosage of orforglipron was superior to placebo (estimated treatment differences: 3 mg once daily, -0.78% [95% CI, -1.02% to -0.55%]; 12 mg once daily, -1.08% [95% CI, -1.33% to -0.83%]; 36 mg once daily, -1.03% [95% CI, -1.28% to -0.77%]; P < .001 for all). All key secondary outcomes demonstrated statistically significant differences in favor of orforglipron compared with placebo. Mean percentage body weight change from baseline was -2.6%, -4.8%, and -5.4% with orforglipron, 3 mg once daily, 12 mg once daily, and 36 mg once daily, respectively, vs 0.2% with placebo. The most frequent adverse events with orforglipron were gastrointestinal (mild to moderate). Orforglipron did not increase the risk of clinically significant hypoglycemia vs placebo. **Conclusions and relevance:** In participants with type 2 diabetes inadequately controlled by insulin glargine, addition of oral orforglipron significantly improved glycemic control and body weight, without increasing hypoglycemia risk, compared with placebo. **Trial registration:** ClinicalTrials.gov Identifier: [NCT06109311](http://clinicaltrials.gov/show/NCT06109311 "See in ClinicalTrials.gov"). [PubMed Disclaimer](https://pubmed.ncbi.nlm.nih.gov/disclaimer/) ## Conflict of interest statement Conflict of Interest Disclosures: Dr Giorgino reported having unpaid leadership roles with the European Association for the Study of Diabetes, the European Foundation for the Study of Diabetes, and the European Diabetes Forum; receiving personal fees from AstraZeneca, Biomea Fusion, Boehringer Ingelheim, Eli Lilly and Company, Kayothera, LifeScan, MSD, Medtronic, Novo Nordisk, Roche Diabetes Care, and Sanofi; receiving nonfinancial support from AstraZeneca, Boehringer Ingelheim, Eli Lilly and Company, Medtronic, Novo Nordisk, Roche Diabetes Care, and Sanofi; and receiving grants from Eli Lilly and Company and Roche Diabetes Care. Dr D’Souza reported receiving personal fees from Eli Lilly and Company and Novo Nordisk. Dr Ludwig reported being an employee of and having stock/shares in Eli Lilly and Company. Dr Kiyosue reported receiving personal fees from Tanabe Pharma, Sumitomo Pharma, Daiichi Sankyo, Ono Pharmaceutical, AstraZeneca, Takeda, Eli Lilly and Company, Boehringer Ingelheim, Kowa, Novartis Pharma, Kyowa Kirin, MSD, and Novo Nordisk. Dr Denning reported being an employee of and having stock/shares in Eli Lilly and Company. Dr Wu reported being an employee of Eli Lilly and Company. Dr Fernández Landó reported being an employee of and having stock/shares in Eli Lilly and Company. No other disclosures were reported. ## Comment on * [ Mazdutide and Orforglipron-New Evidence in Obesity and Diabetes. ](https://pubmed.ncbi.nlm.nih.gov/42251768/) Gadde KM, Talebloo J, Heymsfield SB. Gadde KM, et al. JAMA. 2026 Aug 4;336(5):374-376. doi: 10.1001/jama.2026.10443. JAMA. 2026. PMID: 42251768 No abstract available. ## Similar articles * [ Tirzepatide vs Insulin Lispro Added to Basal Insulin in Type 2 Diabetes: The SURPASS-6 Randomized Clinical Trial. ](https://pubmed.ncbi.nlm.nih.gov/37786396/) Rosenstock J, Frías JP, Rodbard HW, Tofé S, Sears E, Huh R, Fernández Landó L, Patel H.Rosenstock J, et al.JAMA. 2023 Nov 7;330(17):1631-1640. doi: 10.1001/jama.2023.20294.JAMA. 2023.PMID: 37786396Free PMC article.Clinical Trial. * [ HRS-7535 for Type 2 Diabetes Inadequately Controlled With Metformin: A Randomized Clinical Trial. ](https://pubmed.ncbi.nlm.nih.gov/42234428/) Guo L, Sun Z, Zhang L, Qin G, Li Y, Chen X, Xu N, Su X, Mao L, Sun J, Cheng Z, Shi X, Wang F, Wang Q, Pan R, Ding S, Ye Z, Xu Y, Liu P.Guo L, et al.JAMA Netw Open. 2026 Jun 1;9(6):e2615622. doi: 10.1001/jamanetworkopen.2026.15622.JAMA Netw Open. 2026.PMID: 42234428Free PMC article.Clinical Trial. * [ Once-Weekly Insulin Icodec vs Once-Daily Insulin Degludec in Adults With Insulin-Naive Type 2 Diabetes: The ONWARDS 3 Randomized Clinical Trial. ](https://pubmed.ncbi.nlm.nih.gov/37354562/) Lingvay I, Asong M, Desouza C, Gourdy P, Kar S, Vianna A, Vilsbøll T, Vinther S, Mu Y.Lingvay I, et al.JAMA. 2023 Jul 18;330(3):228-237. doi: 10.1001/jama.2023.11313.JAMA. 2023.PMID: 37354562Free PMC article.Clinical Trial. * [ Effect of Oral Semaglutide Compared With Placebo and Subcutaneous Semaglutide on Glycemic Control in Patients With Type 2 Diabetes: A Randomized Clinical Trial. ](https://pubmed.ncbi.nlm.nih.gov/29049653/) Davies M, Pieber TR, Hartoft-Nielsen ML, Hansen OKH, Jabbour S, Rosenstock J.Davies M, et al.JAMA. 2017 Oct 17;318(15):1460-1470. doi: 10.1001/jama.2017.14752.JAMA. 2017.PMID: 29049653Free PMC article.Clinical Trial. * [ Folic acid supplementation and malaria susceptibility and severity among people taking antifolate antimalarial drugs in endemic areas. ](https://pubmed.ncbi.n
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