ACHIEVE-J

CompletedPhase 3

A Long-term Safety Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes

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)

Lead sponsor

Eli Lilly and Company

Asset

Orforglipron

Oral · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

466

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI ≥23•HbA1c ≥7%

Primary endpoint

•Treatment-emergent AEs (any)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06010004

Org study ID18745

Secondary IDJ2A-JE-GZPEEli Lilly and Company

Timeline

Milestones

Study first posted2023-08-24actual

Study start2023-09-28actual

Primary completion2025-06-05actual

Study completion2025-06-05actual

Last update posted2025-07-14actual

Assets

Investigational agents

Orforglipron

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (13)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition

Glycemic / diabetes

Safety / tolerability / PK

Weight & body composition

6 endpoints

Secondary/protocol endpoint

Change from Baseline in Body Weight

Time frame:Baseline, Week 52

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants who Achieve Weight Loss of ≥5%

Time frame:Week 52

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants who Achieve Weight Loss of ≥10%

Time frame:Week 52

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants who Achieve Weight Loss of ≥15%

Time frame:Week 52

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Change from Baseline in Waist Circumference

Time frame:Baseline, Week 52

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Body Mass Index (BMI)

Time frame:Baseline, Week 52

BMI, change

change from baseline, improvement

Glycemic / diabetes

6 endpoints

Secondary/protocol endpoint

Change from Baseline in Hemoglobin A1c (HbA1c)

Time frame:Baseline, Week 52

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participants who Achieve HbA1c <7.0% (<53 mmol/mol)

Time frame:Week 52

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participants who Achieve HbA1c ≤6.5% (<48 mmol/mol)

Time frame:Week 52

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participants who Achieve HbA1c <5.7% (<39 mmol/mol)

Time frame:Week 52

HbA1c <5.7% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change from Baseline in Fasting Serum Glucose

Time frame:Baseline, Week 52

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change from Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG)

Time frame:Baseline, Week 52

change from baseline, improvement

Safety / tolerability / PK

1 endpoint

Primary/protocol endpoint

Number of Participants with Treatment Emergent Adverse Events (TEAEs)

Time frame:Baseline through Week 52

Treatment-emergent AEs (any)

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.