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| # **Orforglipron Compared with Placebo as an Add-On to Titrated Insulin Glargine: Results From ACHIEVE-5 ** |
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| ## Author: Francesco Giorgino, MD, PhD |
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| 2:10 p.m. - 2:30 p.m. |
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| Copyright @ 2026 Eli Lilly and Company. All rights reserved. |
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| **Orforglipron Compared with Placebo as an Add-On to Titrated Insulin Glargine: Results From ACHIEVE-5 ** |
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| #### **Presenter Disclosure: Francesco Giorgino, MD, PhD** |
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| **Advisory Boards:** AstraZeneca, Biomea, Boehringer-Ingelheim, Eli Lilly, Lifescan, Merck Sharp & Dohme, Medtronic, NovoNordisk, |
| Roche Diabetes Care, Sanofi |
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| **Other Boards:** European Association for the Study of Diabetes (EASD)/European Foundation for the Study of Diabetes (EFSD), |
| European Diabetes Forum (EUDF) |
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| **Consultant:** Eli Lilly, NovoNordisk, Kayothera |
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| **Lectures, presentations, or educational events:** AstraZeneca, Boehringer-Ingelheim, Eli Lilly, Lifescan, Merck Sharp & Dohme, Medtronic, NovoNordisk, Roche Diabetes Care, Sanofi |
| |
| **Research Support:** Eli Lilly, Roche Diabetes Care |
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| **Receipt of Medical Writing or Support for Statistical Analysis:** AstraZeneca, Eli Lilly, NovoNordisk, Roche Diabetes Care, Sanofi |
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| #### **Introduction: Clinical Challenges With Basal Insulin Therapy** |
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| 1\. Riddle M, Umpierrez G, DiGenio A, Zhou R, Rosenstock J. Contributions of Basal and Postprandial Hyperglycemia |
| Over a Wide Range of A1C Levels Before and After Treatment Intensification in Type 2 Diabetes. *Diabetes Care* |
| 34:2508 - 2514, 2011. 2. Monnier L, Lapinski Hln , Colette C: Contributions of Fasting and Postprandial Plasma |
| Glucose Increments to the Overall Diurnal Hyperglycemia of Type 2 Diabetic Patients: Variations with increasing |
| levels of HbA1c. *Diabetes Care* 26:881 - 885, 2003 |
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| #### **Introduction: Adding an Oral GLP-1 RA to Basal Insulin as an Alternative Intensification Strategy** |
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| FDC, fixed-dose combination.\ |
| 1\. Castellana M, Cignarelli A, Brescia F, Laviola L, Giorgino F. GLP-1 receptor agonist added to insulin versus basal-plus or |
| basal-bolus insulin therapy in type 2 diabetes: A systematic review and meta-analysis. *Diabetes/Metab Res* *Rev* 35:e3082, |
| 2019\. 2. Pharmacologic approaches to glycemic treatment : Standards of Care in Diabetes 2026; Diabetes Care 2026;49(Suppl. |
| 1):S183–S215. 3. Management of hyperglycemia in type 2 diabetes, 2022. ADA/EASD Consensus Report. Diabetes |
| Care 2022;45(11):2753–2786. |
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| #### **ACHIEVE-5 Study Design** |
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| ACHIEVE-5 study code is NCT06109311.\ |
| *Abbreviations: OFG=orforglipron; PBO=placebo; QD=once daily; SGLT2=sodium-glucose co-transporter-2; T2D=type 2 |
| diabetes.* |
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| #### **ACHIEVE-5 Key inclusion/exclusion criteria** |
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| ªParticipants already on metformin and/or SGLT-2 inhibitors will continue these medications until the end of the |
| study. |
| |
| *Abbreviations:* ALT=alanine aminotransferase; AST=aspartate aminotransferase; BCRP=breast cancer resistance protein; |
| BMI=body mass index; CYP3A=cytochrome P450 3A; eGFR=estimated glomerular filtration rate; HbA1c=hemoglobin A1c; |
| OATP=organic anion transporting polypeptide; OFG=orforglipron; PBO=placebo; P-gp=P-glycoprotein; QD=once daily; |
| SGLT2=sodium-glucose co-transporter-2; T2D=type 2 diabetes; ULN=upper limit of normal. |
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| #### **ACHIEVE-5 Insulin Glargine Titration** |
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| aBased on the last 3 fasting SMBG values; bDose should be decreased by 1-2 units or 2-4 units |
| if multiple episodes of non-severe hypoglycemia were recorded during the assessment period at any time during the |
| day, and/or if ≥1 episode meeting criteria for severe hypoglycemia (events requiring assistance of a third person to |
| administer therapy) or was associated with SMBG value <54 mg/dL (<3.0 mmol/L) during the assessment period; ᶜ If only |
| 1 hypoglycemic episode with SMBG value ≥54 mg/dL (≥3.0 mmol/L) and ≤70 mg/dL (≤3.9 mmol/L) was recorded, insulin dose |
| should not be changed. |
| |
| *Abbreviations:* HbA1c=hemoglobin A1c; SMBG=self-monitored blood glucose. |
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| #### **ACHIEVE-5 Primary and Key Secondary Endpoints** |
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| aEndpoints were strongly controlled for type 1 error (multiplicity) using a graphical testing procedure.\ |
| Abbreviations: HbA1c=hemoglobin A1c. |
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| #### **ACHIEVE-5 Additional Secondary Endpointsa** |
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| a Not controlled for type 1 error ; p-values are nominal.\ |
| b Change from baseline at Week 40. |
| |
| Abbreviations: BMI=body mass index; FSG=fasting serum glucose; HbA1c=hemoglobin A1c .. |
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| #### **ACHIEVE-5 Participant Disposition** |
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| **Note:** Study completion is defined as the participant completing both the treatment period and the safety |
| follow-up period, regardless of completion of the study intervention. |
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+-----------------------------------------------------------------------------------------------------------------+
| #### **ACHIEVE-5 Baseline Characteristics - 1/2** |
+-----------------------------------------------------------------------------------------------------------------+
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| |
+-----------------------------------------------------------------------------------------------------------------+
| |
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| ![DV-040626\_ACHIEVE-5\_GZGW\_-p012-img-0][image9] |
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+---------------------------------------------------------------------------------------------------------------------+
| **Notes:** Data are shown as mean (SD) unless stated otherwise. Data from all randomized participants. |
| |
| **Abbreviations**: n=number of subjects in the specified category ; N=number of participants in the population; |
| SD=standard deviation . |
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| #### **ACHIEVE-5 Baseline Characteristics - 2/2** |
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| **Notes:** Data are shown as mean (SD) unless stated otherwise. Data from all randomized participants with non - missing data. |
| |
| **Abbreviations:** BMI=body mass index; FSG=fasting serum glucose; HbA1c=hemoglobin A1c; n=number of subjects in the specified |
| category ; N= number of participants in the population; OFG=orforglipron; PBO=placebo; SD=standard deviation; SGLT2=sodium - |
| glucose co - transporter - 2; T2D=type 2 diabetes. |
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| |
+---------------------------------------------------------------------------------------------------------------------+
| #### **ACHIEVE-5 Insulin Dose and Change in Fasting Serum Glucose From Baseline Over 40 Weeks** (Efficacy Estimand) |
+---------------------------------------------------------------------------------------------------------------------+
| |
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| |
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| Orforglipron vs. placebo: #p<0.05 ##p<0.01, and ###p<0.001. Comparison to placebo not controlled for family-wise |
| error rate. Arrows indicate when the maintenance doses of orforglipron 2.5 mg, 9 mg, and 17.2 mg are achieved. |
| |
| Notes: Data in line plot are raw mean (SE); other data are MBE (SE) unless stated otherwise. EE analysis was |
| conducted using MMRM on randomized participants and EE data points set. |
| |
| *Abbreviations: EE=efficacy estimand; FSG=fasting serum glucose; MBE=model-based estimate; MMRM=mixed model for |
| repeated measures; N=total number of participants; SD=standard deviation; SE=standard error.* |
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| #### **ACHIEVE-5 Change in HbA1c From Baseline Over 40 Weeks** |
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| Orforglipron vs. placebo: \*\*\*p<0.001. p-values are for MBE change difference vs. placebo. Arrows indicate when the |
| maintenance doses of orforglipron 2.5 mg, 9 mg, and 17.2 mg are achieved. \ |
| Notes: Data in line plot are raw mean (SE); all other data are MBE (SE) unless stated otherwise. EE analysis was |
| conducted using MMRM on randomized participants and EE data points set. TRE analysis was conducted using ANCOVA on |
| randomized participants and TRE data points set, with missing data imputed 50 times. |
| |
| *Abbreviations: ANCOVA=analysis of covariance; EE=efficacy estimand; HbA1c=hemoglobin A1c; MBE=model-based estimate; |
| MMRM=mixed model for repeated measures; N=total number of participants; SD=standard deviation; SE=standard |
| error;TRE=treatment regimen estimand.* |
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+-----------------------------------------------------------------------------------------------------------------+
| #### **ACHIEVE-5 Proportion of Participants Reaching HbA1c Targets at Week 40** |
+-----------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------+
| |
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| |
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| |
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| p-values are for risk difference vs. placebo. \*\*\* = p<0.001. *##* = p<0.01 and *###* = p<0.001 for comparisons to |
| placebo not controlled for Family-wise error rate (HbA1c <5.7% data). All analyses were prespecified. |
| |
| Notes: Data are proportion of participants (%) achieving HbA1c targets <7∙0%, ≤6∙5%, and <5∙7% for the EE analysis |
| conducted using logistic regression model on randomized participants and EE data points set, with missing data |
| imputed 50 times. \ |
| *Abbreviations: EE=efficacy estimand; HbA1c=hemoglobin A1c; MBE=model-based estimate; N=total number of participants; |
| SE=standard error.* |
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+-----------------------------------------------------------------------------------------------------------------+
| #### **ACHIEVE-5 7-Point SMBG From Baseline to Week 40** |
+-----------------------------------------------------------------------------------------------------------------+
| |
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| |
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| **Orforglipron vs. placebo:** # p<0.05, ## p<0.01, ### p<0.001. Comparison to placebo was not controlled for Family-wise error rate. |
| |
| **Notes:** Data are MBE (SE). Analysis was conducted using MMRM on randomized participants and EE data points set. |
| |
| **Abbreviations:** EE=efficacy estimand; MMRM=mixed model for repeated measures; N=total number of participants in EE data set; |
| SE=standard error; SMBG=self-monitored blood glucose. |
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+-----------------------------------------------------------------------------------------------------------------+
| #### **ACHIEVE-5 Change in Body Weight (%) From Baseline Over 40 Weeks** |
+-----------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------+
+-----------------------------------------------------+
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| **Orforglipron vs. placebo:** \*\*\*p<0.001. p-values are for MBE change difference vs. placebo. Arrows indicate when |
| the maintenance doses of orforglipron 2.5 mg, 9 mg, and 17.2 mg are achieved. |
| |
| **Notes:** Data in line plot are raw mean (SE); all other data are MBE (SE) unless stated otherwise. EE analysis was |
| conducted using MMRM on randomized participants and EE data points set. TRE analysis was conducted using ANCOVA on |
| randomized participants and TRE data points set, with missing data imputed 50 times. All analyses were prespecified. |
| |
| **Abbreviations:** ANCOVA=analysis of covariance; EE=efficacy estimand; MBE=model-based estimate; MMRM=mixed model |
| for repeated measures; N=total number of participants; SD=standard deviation; SE=standard error; TRE=treatment |
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+-----------------------------------------------------------------------------------------------------------------+
| #### **ACHIEVE-5 Proportion of Participants Reaching Weight Reduction Thresholds at Week 40** |
+-----------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------+
| |
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| |
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| **Orforglipron vs. placebo:** # p<0.05, ## p<0.01, ### p<0.001 . p - values are for risk difference vs. placebo. All |
| analyses were prespecified. Comparison to placebo was not controlled for Family - wise error rate . |
| |
| **Notes:** Data are Group Mean (SE) (%) unless stated otherwise. Analysis was conducted using logistic regression |
| model on randomized participants and EE data points set, with missing data imputed 50 times. |
| |
| **Abbreviations:** EE=efficacy estimand; MBE=model - based estimate ; SE=standard error. |
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| #### **ACHIEVE-5 Overview of Adverse Events** |
+-----------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------+
| |
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| a Death is also included as serious AE and discontinuations due to AE. |
| |
| Notes: Data are reported for the safety data points set. Safety population defined as all participants who were randomly |
| assigned a study intervention and who received ≥1 dose of study intervention. |
| |
| *Abbreviations: AE=adverse event; MedDRA=Medical Dictionary for Regulatory Activities; n=number of participants with |
| events meeting specified criteria; N=number of participants in analysis population; TEAE=treatment-emergent AE.* |
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| #### **ACHIEVE-5 Overview of Adverse Events** |
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| a Death is also included as serious AE and discontinuations due to AE. |
| |
| **Notes:** Data are reported for the safety data points set. Safety population defined as all participants who were |
| randomly assigned a study intervention and who received ≥1 dose of study intervention. |
| |
| **Abbreviations:** AE=adverse event; MedDRA=Medical Dictionary for Regulatory Activities; n=number of participants |
| with events meeting specified criteria; N=number of participants in analysis population ; TEAE=treatment - emergent |
| AE. |
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| #### **ACHIEVE-5 AE of Hypoglycemia** |
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| Numbers for hypoglycemia exclude hypoglycemic events occurring after initiation of any new anti-hyperglycemic |
| therapy. aSevere hypoglycemia is characterized by altered mental and/or physical status requiring |
| assistance for treatment of hypoglycemia. |
| |
| **Notes:** Data are reported for the safety data points set. Safety population defined as all participants who were |
| randomly assigned a study intervention and who received ≥1 dose of study intervention. |
| |
| **Abbreviations:** AE=adverse event; n=number of participants with events meeting specified criteria; N=number of |
| participants in analysis population. |
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| #### **ACHIEVE-5 Changes From Baseline in Liver Enzymes** |
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| |
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| **Note:** Data are MBE (SE) unless stated otherwise. Safety analysis was conducted using MMRM on safety participants |
| (N=544) and safety data points set. |
| |
| **Abbreviations:** ALT=alanine aminotransferase; AST=aspartate aminotransferase; MBE=model - based estimate; |
| SD=standard deviation; SE =standard error; SFU=safety follow - up. |
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| #### **ACHIEVE-5 Change in Blood Pressure From Baseline** |
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+-----------------------------------------------------------------------------------------------------------------------+
| |
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| |
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| |
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| |
+-----------------------------------------------------------------------------------------------------------------------+
| Arrows indicate when the maintenance doses of orforglipron 2.5 mg, 9 mg, and 17.2 mg are achieved. |
| |
| **Notes:** Data are MBE (SE) unless stated otherwise. Safety analysis was conducted using MMRM on safety participants |
| (N=544) and safety data points set. |
| |
| **Abbreviations:** MBE=model-based estimate; MMRM=mixed model for repeated measures; N=total number of participants |
| in the estimand guiding safety data set; SD=standard deviation; SE=standard error; SFU=safety follow-up. |
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| #### **ACHIEVE-5 Change in Pulse Rate From Baseline** |
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| |
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| |
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| |
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| |
| **Notes:** Data are MBE (SE) unless stated otherwise. Safety analysis was conducted using MMRM on safety participants |
| (N=544) and safety data points set. |
| |
| MBE=model - based estimate; MMRM=mixed model for repeated measures; N=total number of participants in the estimand |
| guiding safety data set; SD=standard deviation; SE=standard error. |
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| #### **Conclusions** |
+-----------------------------------------------------------------------------------------------------------------+
| |
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| |
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| |
+-----------------------------------------------------------------------------------------------------------------+
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| **JAMA** |
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+------------------------------------------------------------------------------------------------------------------+
| ![DV-040626\_ACHIEVE-5\_GZGW\_-p027-img-0][image24] |
+------------------------------------------------------------------------------------------------------------------+
| |
+------------------------------------------------------------------------------------------------------------------+
| Scan to read the article. |
+------------------------------------------------------------------------------------------------------------------+
| #### Orforglipron Added to Titrated Insulin Glargine in Type 2 Diabetes |
+------------------------------------------------------------------------------------------------------------------+
| ###### Giorgino F, D’Souza S, Ludwig L, et al |
| |
| #### The ACHIEVE-5 Randomized Clinical Trial |
| |
| ###### Published online June 7, 2026
American Diabetes Association Scientific Sessions |
+------------------------------------------------------------------------------------------------------------------+
| Available at jama.com |
+------------------------------------------------------------------------------------------------------------------+
| |
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| Thank You |
+------------------------------------------------------------------------------------------------------+
| Copyright @ 2026 Eli Lilly and Company. All rights reserved. |
+------------------------------------------------------------------------------------------------------+
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| Metadata |
+--------------------------+----------------------------------------------------------------------------------------------------------------------------------------------------------+
| title | Orforglipron Compared with Placebo as an Add-On to Titrated Insulin Glargine: Results From ACHIEVE-5 |
+--------------------------+----------------------------------------------------------------------------------------------------------------------------------------------------------+
| published-time | 2026-06-16T17:30:47.848Z |
+--------------------------+----------------------------------------------------------------------------------------------------------------------------------------------------------+
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| json-ld | { "@context": "https\://schema.org", "@type": "MedicalTrial", "@id": "https\://www\.lilly.com/hcp/congresses/ada-2026/dv-040626-achieve-5", |
| | "name": "ACHIEVE-5: Orforglipron Compared with Placebo as an Add-On to Titrated Insulin Glargine", "alternateName": "ACHIEVE-5", "identifier": \[ |
| | { "@type": "PropertyValue", "propertyID": "ClinicalTrials.gov", "value": "NCT06109311" } ], "description": "A Phase 3, 4-arm, |
| | randomized, double-blind, placebo-controlled, parallel-group trial of 40 weeks duration evaluating the efficacy and safety of orforglipron (2.5 mg, 9 |
| | mg, and 17.2 mg once daily) compared with placebo as an add-on to titrated insulin glargine in adults with type 2 diabetes. Drugs studied: orforglipron |
| | (oral GLP-1 receptor agonist) and insulin glargine (basal insulin). N=546 randomized (screened N=781): Placebo (N=141), Orforglipron 2.5 mg (N=137), |
| | Orforglipron 9 mg (N=132), Orforglipron 17.2 mg (N=136). Eligibility: adults with T2D and HbA1c 7.0-10.5%, BMI 23 kg/m2 or greater, on stable insulin |
| | glargine alone or with metformin and/or SGLT-2 inhibitors for 90 days or more. Exclusions: eGFR less than 15 mL/min/1.73 m2, ALT/AST greater than 5x |
| | ULN, severe hypoglycemia or hypoglycemia unawareness within 6 months, current or planned treatment for diabetic retinopathy or diabetic macular edema. |
| | Key results: orforglipron demonstrated HbA1c reductions up to 2.05%, body weight reductions up to 6.1%, and significant improvements in fasting serum |
| | glucose and 7-point SMBG vs placebo at week 40. Presented at the American Diabetes Association Scientific Sessions 2026, June 6-9, by Francesco |
| | Giorgino, MD, PhD at 2:10-2:30 p.m.", "trialDesign": { "@type": "MedicalTrialDesign", "name": "MultipleGroups" }, "status": "Completed", |
| | "healthCondition": { "@type": "MedicalCondition", "name": "Type 2 Diabetes Mellitus", "code": { "@type": "MedicalCode", |
| | "codeValue": "E11", "codingSystem": "ICD-10" } }, "sponsor": { "@type": "Organization", "name": "Eli Lilly and Company", |
| | "url": "https\://www\.lilly.com" }, "subjectOf": { "@type": "ScholarlyArticle", "name": "Orforglipron Added to Titrated Insulin Glargine in |
| | Type 2 Diabetes: The ACHIEVE-5 Randomized Clinical Trial", "author": { "@type": "Person", "name": "Francesco Giorgino", |
| | "honorificPrefix": "Prof.", "honorificSuffix": "MD, PhD", "jobTitle": "Professor of Endocrinology", "affiliation": { "@type": |
| | "Organization", "name": "University of Bari Aldo Moro", "department": "Department of Precision and Regenerative Medicine and Ionian |
| | Area, Section of Internal Medicine, Endocrinology, Andrology and Metabolic Diseases" } }, "publisher": { "@type": "Organization", |
| | "name": "JAMA" }, "datePublished": "2026-06-07", "copyrightYear": 2026, "copyrightHolder": { "@type": "Organization", |
| | "name": "Eli Lilly and Company" }, "keywords": "orforglipron, GLP-1 receptor agonist, oral GLP-1, insulin glargine, basal insulin, type 2 |
| | diabetes, HbA1c, glycemic control, body weight, ACHIEVE-5, ADA 2026", "url": "https\://jama.com" }, "url": |
| | "https\://www\.lilly.com/hcp/congresses/ada-2026/dv-040626-achieve-5" } |
+--------------------------+----------------------------------------------------------------------------------------------------------------------------------------------------------+
| modified-time | 2026-06-16T15:28:19.262Z |
+--------------------------+----------------------------------------------------------------------------------------------------------------------------------------------------------+
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