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Orforglipron-Diabetes

This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling.

What orforglipron clinical trials are being conducted in people with type 2 diabetes?

The ACHIEVE clinical trial program will evaluate orforglipron in adults with type 2 diabetes. The phase 3b study GZP2 is evaluating orforglipron in participants with obesity or overweight with type 2 diabetes.

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Orforglipron Phase 3 Clinical Studies

Orforglipron is a novel, once-daily, oral, nonpeptide glucagon-like peptide-1 receptor agonist (GLP-1 RA) being developed for the treatment of adults with type 2 diabetes (T2D) and obesity.1

Eli Lilly and Company does not have any ongoing clinical trials comparing the efficacy and safety of orforglipron with injectable GLP-1 RAs or tirzepatide.

Phase 3 Orforglipron Clinical Studies for the Treatment of Type 2 Diabetes

The ACHIEVE clinical trial program assesses the efficacy and safety of orforglipron as a treatment for T2D in adults (Overview of the ACHIEVE Phase 3 Clinical Trial Program of Orforglipron for the Treatment of T2D).

Overview of the ACHIEVE Phase 3 Clinical Trial Program of Orforglipron for the Treatment of T2D
Trial, Target Population, and Trial Status	Key Inclusion Criteria	Concomitant Therapya	Orforglipron Groups	Comparator	Primary Endpoint(s)	Primary Timepoint
Global trials
ACHIEVE-12 in People With T2D NCT05971940 Complete	T2D HbA1c ≥7.0% to ≤9.5% Naïve to insulin and not on antihyperglycemic medications 90 days prior to study start BMI ≥23.0 kg/m²	None	Oral Once daily 3 mg, 12 mg, or 36 mg doses	PBO	CFB in HbA1c	40 weeks
ACHIEVE-23 in People With T2D NCT06192108 Ongoing	T2D HbA1c ≥7.0% to ≤10.5% BMI ≥23.0 kg/m²	MET	Oral Once daily	DAPAb	CFB in HbA1c	40 weeks
ACHIEVE-34 in People With T2D NCT06045221 Ongoing	T2D HbA1c ≥7.0% to ≤10.5%	MET	Oral Once daily	SEMAb	CFB in HbA1c	52 weeks
ACHIEVE-45 in People With T2D and Obesity or Overweight at Increased Risk for CV events NCT05803421 Ongoing	T2D HbA1c ≥7.0% to ≤10.5%c, or ≥7.5% to ≤10.5%d Increased CV riske BMI ≥25 kg/m²	1-3 OAMs of MET, SGLT2i, or SU	Oral Once daily	iGLARf	Time to first occurrence of any MACE-4g	Event driven
ACHIEVE-56 in People With T2D NCT06109311 Ongoing	T2D HbA1c ≥7.0% to ≤10.5% BMI ≥23.0 kg/m²	iGLAR alone or in combination with MET, SGLT2i, or both	Oral Once daily	PBOb	CFB in HbA1c	40 weeks
Regional trial
ACHIEVE-J7 in People With T2D in Japan NCT06010004 Ongoing	T2D HbA1c ≥7.0% to ≤10.5% BMI ≥23.0 kg/m²	Monotherapy or OAM	Oral	None	Number of participants with ≥1 TEAE	52 weeks

Abbreviations: BMI = body mass index; CFB = change from baseline; CHD = coronary heart disease; CHF = congestive heart failure; CKD = chronic kidney disease; CV = cardiovascular; DAPA = dapagliflozin; HbA1c = glycated hemoglobin; iGLAR = insulin glargine; MACE-4 = major adverse cardiovascular events; MET = metformin; NYHA = New York Heart Association; OAM = oral antihyperglycemic medication; PBO = placebo; SC = subcutaneously; SEMA = semaglutide; SGLT2i = sodium-glucose cotransporter-2 inhibitor; SU = sulfonylurea; T2D = type 2 diabetes; TEAE = treatment-emergent adverse event.

aFor the treatment of T2D.

bAdministered orally.

cBackground T2D medication does not include SU.

dBackground T2D medication includes SU.

eDue to CHD, PAD (presumed to be of atherosclerotic origin), cerebrovascular disease (presumed to be of atherosclerotic origin), CKD, CHF NYHA II to III.

fAdministered SC once daily.

gMyocardial infarction, stroke, hospitalization for unstable angina, or CV death.

The J2A-MC-GZPO master protocol is designed to evaluate the efficacy and safety of orforglipron tablet once daily in participants who have obesity or overweight with or without T2D.8,9

Please refer to Overview of Orforglipron Tablet Once Daily Phase 3 Study in Participants With Obesity or Overweight With Type 2 Diabetes for more information about one of the master protocol studies, J2A-MC-GZP2, in participants with obesity or overweight and T2D.

Overview of Orforglipron Tablet Once Daily Phase 3 Study in Participants With Obesity or Overweight With Type 2 Diabetes
Trial, Target Population, and Trial Status	Key Inclusion Criteria	Concomitant Therapy	Orforglipron Groups	Comparator	Primary Endpoint	Primary Timepoint
J2A-MC-GZP29 in People With Obesity or Overweight With T2D NCT06972472 Ongoing	BMI ≥25 kg/m² T2D HbA1c ≥7% to ≤10% Have a history of at least one unsuccessful dietary effort to lose body weight	None	Oral tablet	PBO	CFB in HbA1c	40 weeks

Abbreviations: BMI = body mass index; CFB = change from baseline; HbA1c = glycated hemoglobin; PBO = placebo; T2D = type 2 diabetes.

References

The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).

1Frias JP, Hsia S, Eyde S, et al. Efficacy and safety of oral orforglipron in patients with type 2 diabetes: a multicentre, randomised, dose-response, phase 2 study. Lancet. 2023;402(10400):472-483. https://doi.org/10.1016/S0140-6736(23)01302-8

2Rosenstock J, Hsia S, Nevarez Ruiz L, et al. Orforglipron, an oral small-molecule GLP-1 receptor agonist, in early type 2 diabetes. N Engl J Med. 2025;392(25):1234-1245. https://doi.org/10.1056/NEJMoa2505669

3A study of orforglipron (LY3502970) compared with dapagliflozin in adult participants with type 2 diabetes and inadequate glycemic control with metformin (ACHIEVE-2). ClinicalTrials.gov identifier: NCT06192108. Updated March 19, 2024. Accessed April 2, 2024. https://clinicaltrials.gov/study/NCT06192108

4A study of orforglipron (LY3502970) compared with semaglutide in participants with type 2 diabetes inadequately controlled with metformin (ACHIEVE-3). ClinicalTrials.gov identifier: NCT06045221. Updated March 8, 2024. Accessed March 14, 2024. https://clinicaltrials.gov/study/NCT06045221

5A study of daily oral orforglipron (LY3502970) compared with insulin glargine in participants with type 2 diabetes and obesity or overweight at increased cardiovascular risk (ACHIEVE-4). ClinicalTrials.gov identifier: NCT05803421. Updated March 13, 2024. Accessed March 14, 2024. https://clinicaltrials.gov/study/NCT05803421

6A study of orforglipron (LY3502970) in participants with type 2 diabetes and inadequate glycemic control with insulin glargine, with or without metformin and/or SGLT-2 inhibitor (ACHIEVE-5). ClinicalTrials.gov identifier: NCT06109311. Updated March 7, 2024. Accessed March 14, 2024. https://clinicaltrials.gov/study/NCT06109311

7A long-term safety study of orforglipron (LY3502970) in participants with type 2 diabetes (ACHIEVE-J). ClinicalTrials.gov identifier: NCT06010004. Updated February 29, 2024. Accessed March 14, 2024. https://clinicaltrials.gov/study/NCT06010004

8A master protocol for orforglipron (LY3502970) in participants with obesity or overweight with and without type 2 diabetes. ClinicalTrials.gov identifier: NCT06993792. Updated May 29, 2025. Accessed June 17,2025. https://clinicaltrials.gov/study/NCT06993792

9A study of orforglipron (LY3502970) in participants with obesity or overweight and type 2 diabetes. ClinicalTrials.gov identifier: NCT06972472. Updated June 8, 2025. Accessed June 17,2025. https://clinicaltrials.gov/study/NCT06972472

Date of Last Review: June 17, 2025

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