DelfaGLP-1 Atlas

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ACHIEVE-3

CompletedPhase 3

A Study of Orforglipron (LY3502970) Compared With Semaglutide in Participants With Type 2 Diabetes Inadequately Controlled With Metformin

A Phase 3, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Once Daily Oral LY3502970 Compared With Oral Semaglutide in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin (ACHIEVE-3)

Assets

Orforglipron / Semaglutide

Listed sites

131

Recruiting sites

—

Enrollment

1,698

actual

Study population

Type 2 diabetes

Key I/E criterion

•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 IDNCT06045221
Org study ID18565
Secondary IDJ2A-MC-GZGUEli Lilly and Company
Secondary IDU1111-1290-6014UTN Number

Timeline

Milestones

Study first posted2023-09-21actual
Study start2023-09-22actual
Primary completion2025-08-22actual
Study completion2025-08-22actual
Last update posted2025-09-22actual

Assets

Investigational agents

OrforglipronSemaglutide

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
•Have HbA1c ≥7.0% (53 mmol/mol) to ≤10.5% (91 mmol/mol), as determined by the central laboratory at screening.
•Have been on stable diabetes treatment with metformin ≥1500 milligram (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

Exclusion criteria

•Have Type 1 Diabetes
•Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema, for example, laser photocoagulation or intravitreal injections of anti-vascular endothelial growth factor inhibitors.
•Have a history of ketoacidosis or hyperosmolar state or coma within the last 6 months prior to screening, or between screening and randomization.
•Have a New York Heart Association functional classification IV congestive heart failure.
•Have an estimated glomerular filtration rate (eGFR) <45 milliliter/minute (mL/min)/1.73 square meter (m²) or lower than the country-specific threshold for discontinuing metformin therapy per local label as determined by the central laboratory at screening.
•Have a serum calcitonin level of ≥35 nanogram/Liter (ng/L), as determined by the central laboratory at screening.
•Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years.

Endpoints (21)

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

Cardiometabolic biomarkers
8
Glycemic / diabetes
7
Weight & body composition
5
Patient-reported / QoL
1

Weight & body composition

5 endpoints
Secondary/protocol endpoint

Percentage Change from Baseline in Body Weight

Time frame:Baseline, Week 52

Body weight, % change

percent change from baseline, improvement

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 Achieved Weight Loss of ≥5%

Time frame:Week 52

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Who Achieved Weight Loss of ≥10%

Time frame:Week 52

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Who Achieved Weight Loss of ≥15%

Time frame:Week 52

≥15% weight-loss responders

threshold achievement, improvement

Glycemic / diabetes

7 endpoints
Primary/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

Change from Baseline in HbA1c

Time frame:Baseline, Week 52

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 52

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 52

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participants Who Achieved 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

Cardiometabolic biomarkers

8 endpoints
Secondary/protocol endpoint

Change from Baseline in Systolic Blood Pressure (SBP)

Time frame:Baseline, Week 52

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 52

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

Percentage Change from Baseline in Total Cholesterol

Time frame:Baseline, Week 52

Total cholesterol, change

percent change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

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

Time frame:Baseline, Week 52

HDL-C, change

percent change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

Percentage Change from Baseline in Low Density Lipoprotein (LDL)-Cholesterol

Time frame:Baseline, Week 52

LDL-C, change

percent change from baseline, improvement

LOINC 13457-7

Secondary/protocol endpoint

Percentage Change from Baseline in Very Low Density Lipoprotein (VLDL)-Cholesterol

Time frame:Baseline, Week 52

VLDL, change

percent change from baseline, improvement

Secondary/protocol endpoint

Percentage Change from Baseline in Non-HDL-Cholesterol

Time frame:Baseline, Week 52

Non-HDL cholesterol, change

percent change from baseline, improvement

Secondary/protocol endpoint

Percentage Change from Baseline in Triglycerides

Time frame:Baseline, Week 52

Triglycerides, change

percent change from baseline, improvement

LOINC 2571-8

Patient-reported / QoL

1 endpoint
Secondary/protocol endpoint

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

Time frame:Baseline, Week 52

SF-36 total

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

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.