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Orforglipron-Diabetes

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

The ACHIEVE clinical trial program evaluates investigational doses of orforglipron for the treatment of type 2 diabetes in adults.

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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 investigational doses 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 and Target Population	Key Inclusion Criteria	Concomitant Therapya	Orforglipron Groups	Comparator	Primary Endpoint(s)	Primary Timepoint
Global trials
ACHIEVE-12 in People With T2D NCT05971940	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	PBO	CFB in HbA1c	40 weeks
ACHIEVE-23 in People With T2D NCT06192108	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	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	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	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	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.

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

2A study of orforglipron (LY3502970) in adult participants with type 2 diabetes and inadequate glycemic control with diet and exercise alone (ACHIEVE-1). ClinicalTrials.gov identifier: NCT05971940. Updated March 6, 2024. Accessed March 14, 2024. https://clinicaltrials.gov/study/NCT05971940

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: March 14, 2024

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Orforglipron-Diabetes

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

The ACHIEVE clinical trial program evaluates investigational doses of orforglipron for the treatment of type 2 diabetes in adults.

ACHIEVE Clinical Trial Program: Orforglipron for the Treatment of Type 2 Diabetes

References

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