Phase 3 · Orforglipron

ACHIEVE-J trial results

A Phase 3, Long-term Safety Study of LY3502970 in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone or in Combination With Oral Antihyperglycemic Medications (ACHIEVE-J)

Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Participants), Baseline to Week 54. 3 mg Orforglipron: 107; 12 mg Orforglipron: 114; 36 mg Orforglipron: 118.

Participants: 401
Status: completed
Completed: 2025-06-05
Sponsor: Eli Lilly and Company

As posted on ClinicalTrials.gov (NCT06010004), updated at source Jun 30, 2026. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What ACHIEVE-J measured first

Number of Participants With Treatment Emergent Adverse Events (TEAEs)Participants · Baseline to Week 54 · count of participants

3 mg Orforglipronn=132	12 mg Orforglipronn=135	36 mg Orforglipronn=134
107	114	118

Side effects by arm

Side effects in ACHIEVE-J

Percent of participants affected, Baseline to Week 54. The most common events the registry lists.

Event	3 mg Orforglipron	12 mg Orforglipron	36 mg Orforglipron
Any serious event	3%	2.2%	4.5%
Constipation	16.7%	30.4%	29.1%
Nausea	12.9%	19.3%	27.6%
Nasopharyngitis	17.4%	22.2%	16.4%
Dyspepsia	6.1%	7.4%	13.4%
Vomiting	12.9%	11.1%	12.7%
Diarrhoea	9.1%	11.9%	11.9%
Decreased appetite	2.3%	4.4%	9.7%
Covid-19	9.1%	8.1%	8.2%
Gastrointestinal disorder	8.3%	3.7%	5.2%
Abdominal discomfort	7.6%	4.4%	5.2%
Back pain	6.8%	3.7%	6%
Abdominal distension	3%	6.7%	3.7%
Eructation	1.5%	5.2%	6%
Diabetic retinopathy	5.3%	3%	4.5%
Pyrexia	5.3%	3.7%	1.5%
Lipase increased	5.3%	2.2%	5.2%
Malaise	0.8%	0.7%	4.5%
Dizziness	2.3%	2.2%	4.5%
Headache	3%	3.7%	4.5%
Orthostatic hypotension	2.3%	0%	4.5%
Coronavirus infection	3.8%	0%	2.2%
Pharyngitis	3.8%	3%	2.2%
Cough	3.8%	1.5%	2.2%
Oropharyngeal pain	3.8%	2.2%	0%
Abdominal pain upper	2.3%	3.7%	2.2%

Secondary outcomes

What else it measured

Change From Baseline in Hemoglobin A1c (HbA1c)percentage of HbA1c · Baseline, Week 52 · least squares mean

3 mg Orforglipronn=125	12 mg Orforglipronn=128	36 mg Orforglipronn=125
-1.71(0.072)	-1.97(0.075)	-2.13(0.073)

Percentage of Participants Who Achieved HbA1c <7.0%percentage of participants · Week 52 · mean

3 mg Orforglipronn=125	12 mg Orforglipronn=128	36 mg Orforglipronn=125
82.73(3.25)	86.11(2.86)	90.82(2.52)

Percentage of Participants Who Achieved HbA1c ≤6.5%percentage of participants · Week 52 · mean

3 mg Orforglipronn=125	12 mg Orforglipronn=128	36 mg Orforglipronn=125
62.64(4.11)	76.23(3.57)	84.56(3.27)

Percentage of Participants Who Achieved HbA1c <5.7%percentage of participants · Week 52 · mean

3 mg Orforglipronn=125	12 mg Orforglipronn=128	36 mg Orforglipronn=125
7.70(2.20)	21.92(3.54)	30.51(3.86)

Change From Baseline in Fasting Serum Glucosemilligrams per deciliter (mg/dL) · Baseline, Week 52 · least squares mean

3 mg Orforglipronn=125	12 mg Orforglipronn=128	36 mg Orforglipronn=124
-51.7(1.40)	-55.1(2.86)	-64.5(1.37)

Change From Baseline in Body Weightkilogram (kg) · Baseline, Week 52 · least squares mean

3 mg Orforglipronn=125	12 mg Orforglipronn=127	36 mg Orforglipronn=125
-1.81(0.307)	-5.08(0.474)	-6.75(0.509)

Percentage of Participants Who Achieved Weight Loss of ≥5% From Baselinepercentage of participants · Week 52 · mean

3 mg Orforglipronn=125	12 mg Orforglipronn=127	36 mg Orforglipronn=125
27.00(3.90)	49.52(4.40)	65.14(4.24)

Percentage of Participants Who Achieved Weight Loss of ≥10% From Baselinepercentage of participants · Week 52 · mean

3 mg Orforglipronn=125	12 mg Orforglipronn=127	36 mg Orforglipronn=125
10.11(2.66)	24.68(3.78)	37.91(4.30)

Percentage of Participants Who Achieved Weight Loss of ≥15% From Baselinepercentage of participants · Week 52 · mean

3 mg Orforglipronn=125	12 mg Orforglipronn=127	36 mg Orforglipronn=125
2.79(1.46)	13.96(3.07)	20.94(3.66)

Change From Baseline in Waist Circumferencecentimeter (cm) · Baseline, Week 52 · least squares mean

3 mg Orforglipronn=120	12 mg Orforglipronn=120	36 mg Orforglipronn=110
-2.4(0.43)	-4.6(0.49)	-6.5(0.54)

Change From Baseline in Body Mass Index (BMI)kilogram per square meter (kg/m^2) · Baseline, Week 52 · least squares mean

3 mg Orforglipronn=120	12 mg Orforglipronn=120	36 mg Orforglipronn=110
-0.7(0.12)	-1.9(0.17)	-2.5(0.19)

Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG)mg/dL · Baseline, Week 52 · mean

3 mg Orforglipronn=122	12 mg Orforglipronn=126	36 mg Orforglipronn=123
-66.32(40.622)	-73.14(41.064)	-82.27(39.367)

The trial

How ACHIEVE-J was run

The purpose of this study is to determine the long-term safety of the study intervention orforglipron as a monotherapy or in combination with oral antihyperglycemic medication. This study includes 3 periods as follows: * screening and lead-in period: up to 4 weeks * treatment period: 52 weeks, including 20 weeks of dose escalation, and * safety follow-up period: 2 weeks.

3 mg Orforglipron: Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by the maintenance dose of 3 mg for the remainder of the duration.
12 mg Orforglipron: Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 12 mg at week 12, which was then continued for the remainder of the duration.
36 mg Orforglipron: Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 36 mg at week 20, which was then continued for the remainder of the duration.

Who could join the trial

Inclusion Criteria: * Have Type 2 Diabetes (T2D) * Have HbA1c ≥7.0% (≥53 mmol/mol) to ≤10.5% (≤91 mmol/mol) as determined by the central laboratory at screening. * Are of stable weight (±5%) for at least 90 days prior to screening and agree to not initiate an intensive diet or exercise program during the study with the intent of reducing body weight other than the lifestyle and/or dietary measures for diabetes treatment. * Have a BMI ≥23.0 kilogram/square meter (kg/m²) at screening. Exclusion Criteria: * Have Type 1 Diabetes (T1D). * Have a history of severe hypoglycemia or hypoglycemia unawareness within the last 6 months prior to screening, or between screening and randomization. * Have New York Heart Association functional classification IV congestive heart failure. * Have had any of the following cardiovascular (CV) conditions within 60 days prior to screening, or between screening and randomization. * acute myocardial infarction * cerebrovascular accident (stroke), or * hospitalization for congestive heart failure * Have acute or chronic hepatitis and pancreatitis

Published papers

Papers from ACHIEVE-J

Yabe D, Shiraiwa T, Ugai H, Takeuchi M, Suzuki R. Long-term safety of oral orforglipron in Japanese participants with type 2 diabetes (ACHIEVE-J): a multicentre, randomised, open-label, parallel-group phase 3 trial. Lancet Diabetes Endocrinol. 2026 Aug 17:S2213-8587(26)00138-5. doi: 10.1016/S2213-8587(26)00138-5. Online ahead of print.

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

GLPcompare is an informational data platform, not a medical provider or pharmacy. Nothing here is medical advice, a diagnosis, or a recommendation to start, stop, or change any treatment. Data is aggregated from public sources and can be incomplete or out of date. Always confirm with a licensed clinician and the current FDA label.