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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 evaluates orforglipron for the treatment of type 2 diabetes in adults.
ACHIEVE Clinical Trial Program: Orforglipron for the Treatment of Type 2 Diabetes
Orforglipron is a novel, once-daily, oral, nonpeptide glucagon-like peptide-1 (GLP-1) receptor agonist being developed for the treatment of adults with type 2 diabetes (T2D) and obesity.1
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).
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.
Trial and Target Population |
Key Inclusion Criteria |
Concomitant Therapya |
Orforglipron Groups |
Comparator |
Primary Endpoint(s) |
Primary Timepoint |
Global trials |
||||||
ACHIEVE-12 |
|
None |
Oral |
PBO |
CFB in HbA1c |
40 weeks |
ACHIEVE-23 |
|
MET |
Oral |
DAPAb |
CFB in HbA1c |
40 weeks |
ACHIEVE-34 |
|
MET |
Oral |
SEMAb |
CFB in HbA1c |
52 weeks |
ACHIEVE-45 |
1-3 OAMs of MET, SGLT2i, or SU |
Oral |
iGLARf |
Time to first occurrence of any MACE-4g |
Event driven |
|
ACHIEVE-56 |
|
iGLAR alone or in combination with MET, SGLT2i, or both |
Oral |
PBOb |
CFB in HbA1c |
40 weeks |
Regional trial |
||||||
ACHIEVE-J7 |
|
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.
References
The published reference below is 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
2Lilly's oral GLP-1, orforglipron, demonstrated statistically significant efficacy results and a safety profile consistent with injectable GLP-1 medicines in successful Phase 3 trial. Press release. Eli Lilly and Company; April 17, 2025. Accessed April 17, 2025. https://investor.lilly.com/news-releases/news-release-details/lillys-oral-glp-1-orforglipron-demonstrated-statistically
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
Date of Last Review: April 17, 2025