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ACHIEVE-2

CompletedPhase 3

A Study of Orforglipron (LY3502970) Compared With Dapagliflozin in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin

A Phase 3, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Once Daily Oral Orforglipron Compared With Dapagliflozin in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin (ACHIEVE-2)

Lead sponsor

Eli Lilly and Company

Asset

Orforglipron

Oral · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

962

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI ≥23•HbA1c ≥7%

Primary endpoint

•HbA1c, change

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 IDNCT06192108

Org study ID18566

Secondary ID2023-507206-13-00EU Trial Number

Secondary IDJ2A-MC-GZGVEli Lilly and Company

Secondary IDU1111-1296-1507UTN Number

Timeline

Milestones

Study first posted2024-01-05actual

Study start2024-01-10actual

Primary completion2025-09-26actual

Study completion2025-09-26actual

Last update posted2025-10-20actual

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 a clinical diagnosis of T2D based on the World Health Organization classification or other locally applicable diagnostic standards.

•Have HbA1c ≥7.0% (53 mmol/mol) to ≤10.5% (91 mmol/mol) at screening.

•Have been on stable diabetes treatment with metformin ≥1500 milligram per day (mg/day) during the 90 days prior to screening and maintained through randomization.

•Are of stable body 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 body mass index (BMI) ≥23.0 kilogram/square meter (kg/m²) at screening.

Exclusion criteria

•Have Type 1 Diabetes (T1D)

•Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema

•Have an estimated glomerular filtration rate (eGFR) <45 milliliter per minute (mL/min)/1.73 square meter (m2)

•Have acute or chronic hepatitis

•Have had chronic or acute pancreatitis any time.

•Have been treated with any antihyperglycemic medication (other than metformin) within the 90 days prior to screening.

Endpoints (17)

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

Cardiometabolic biomarkers

Patient-reported / QoL

Weight & body composition

5 endpoints

Secondary/protocol endpoint

Percentage Change from Baseline in Body Weight

Time frame:Baseline, Week 40

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Body Weight

Time frame:Baseline, Week 40

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants Who Achieved Weight Loss of ≥5% from Baseline

Time frame:Baseline to Week 40

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Who Achieved Weight Loss of ≥10% from baseline

Time frame:Baseline to Week 40

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Who Achieved Weight Loss of ≥15% from baseline

Time frame:Baseline to Week 40

≥15% weight-loss responders

threshold achievement, improvement

Glycemic / diabetes

5 endpoints

Primary/protocol endpoint

Change from Baseline in Hemoglobin A1c: (HbA1c)

Time frame:Baseline, Week 40

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change from Baseline in HbA1c

Time frame:Baseline, Week 40

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participants Who Achieved HbA1c <7.0% (53 millimole/mole(mmol/mol))

Time frame:Week 40

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participants Who Achieved HbA1c ≤6.5% (48 mmol/mol)

Time frame:Week 40

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change from Baseline in Fasting Serum Glucose

Time frame:Baseline, Week 40

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Cardiometabolic biomarkers

5 endpoints

Secondary/protocol endpoint

Percentage Change from Baseline in Non-High-Density Lipoprotein (non-HDL)-Cholesterol

Time frame:Baseline, Week 40

Non-HDL cholesterol, change

percent change from baseline, improvement

Secondary/protocol endpoint

Percentage Change from Baseline in Triglycerides

Time frame:Baseline, Week 40

Triglycerides, change

percent change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

Change from Baseline in Systolic Blood Pressure (SBP)

Time frame:Baseline, Week 40

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Change from Baseline in Diastolic Blood Pressure (DBP)

Time frame:Baseline, Week 40

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

Percentage Change from Baseline in Total Cholesterol

Time frame:Baseline, Week 40

Total cholesterol, change

percent change from baseline, improvement

LOINC 2093-3

Patient-reported / QoL

2 endpoints

Secondary/protocol endpoint

Change from Baseline in Short Form 36 Version 2 (SF-36-v2) Acute Form Domain Summary Scores

Time frame:Baseline, Week 40

SF-36 total

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Diabetes Treatment Satisfaction Questionnaire-Change (DTSQc) Scores

Time frame:Baseline, Week 40

change from baseline, improvement

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Welch M, Forst T, Jia W, Del Pino PO, Denning M, Wu WS, Li J, Liu R, Eifu M, Chen Y; ACHIEVE-2 Trial Investigators. Orforglipron compared with dapagliflozin in adults with type 2 diabetes and inadequate glycaemic control with metformin (ACHIEVE-2): a multicentre, randomised, non-inferiority, open-label, phase 3 trial. Lancet. 2026 Jun 8:S0140-6736(26)00800-7. doi: 10.1016/S0140-6736(26)00800-7. Online ahead of print.
PMID42259339via clinicaltrials gov reference derived

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.