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CompletedPhase 2Results posted

A Study of LY3502970 in Participants With Type 2 Diabetes Mellitus

A Phase 2 Study of Once-Daily LY3502970 Compared With Placebo and Once-Weekly Dulaglutide in Participants With Type 2 Diabetes Mellitus

Assets

Dulaglutide / Orforglipron

Listed sites

44

Recruiting sites

Enrollment

383

actual

Study population

Type 2 diabetes

Key I/E criterion

BMI ≥23

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 IDNCT05048719
Org study ID17787
Secondary ID2021-002806-29
Secondary IDJ2A-MC-GZGEEli Lilly and Company

Timeline

Milestones

Study start2021-09-15actual
Study first posted2021-09-17actual
Primary completion2022-09-30actual
Study completion2022-09-30actual
Last update posted2023-10-17actual
Results first posted2023-10-17actual

Assets

Investigational agents

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

Have been diagnosed with Type 2 Diabetes on diet and exercise and/or a stable dose of metformin
Have a stable body weight for the 3 months prior to randomization
Have a body mass index (BMI) ≥23 kilogram/square meter (kg/m²)
Males must agree to use highly effective methods of contraception
Women not of childbearing potential (WNOCBP) may participate in this trial
Note: Hormone replacement therapy in post-menopausal women is allowed but women must be on stable therapy for 3 months prior to day 1.

Exclusion criteria

Have Type 1 diabetes mellitus (T1DM) or history of ketoacidosis or hyperosmolar coma
Have a history of diabetic retinopathy, diabetic maculopathy, or severe non-proliferative diabetic retinopathy that requires immediate treatment intervention
Have had more than 1 episode of severe hypoglycemia and aware of hypoglycemic symptoms
Have acute or chronic pancreatitis
Have obesity induced other endocrine disorders (Cushing's syndrome or Prader - Willi syndrome)
Have gastric emptying abnormality or chronically take medications impacting GI motility
Have poorly controlled hypertension
Have the following heart conditions within the last 6 months: myocardial infarction (MI), unstable angina, coronary artery bypass graft, percutaneous coronary intervention (diagnostic angiograms are permitted), transient ischemic attack (TIA), cerebrovascular accident (stroke)or decompensated congestive heart failure, or IV heart failure
Have any symptoms of other liver diseases besides nonalcoholic fatty liver disease (NAFLD)
Have HIV, or Hepatitis B or Hepatitis C

Endpoints (14)

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

Glycemic / diabetes
10
Weight & body composition
2
Safety / tolerability / PK
2

Weight & body composition

2 endpoints
Secondary/registry result

Change From Baseline in Body Weight

Time frame:Baseline, Week 26

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), kilograms (kg)95% CI
3 mg LY3502970-3.7
12 mg LY3502970-6.5
24 mg LY3502970-9.7
36 mg LY3502970-9.5
45 mg LY3502970-10.1
Placebo-2.2
1.5 mg Dulaglutide-3.9
LS Mean Difference-1.695% CI-3.70.6p0.153Mixed Models Analysis
LS Mean Difference-4.395% CI-6.4-2.2p<0.001Mixed Models Analysis
LS Mean Difference-7.695% CI-9.8-5.3p<0.001Mixed Models Analysis
LS Mean Difference-7.495% CI-9.4-5.3p<0.001Mixed Models Analysis
LS Mean Difference-7.995% CI-9.9-5.9p<0.001Mixed Models Analysis
LS Mean Difference0.195% CI-2.02.3p0.914Mixed Models Analysis
LS Mean Difference-2.695% CI-4.7-0.5p0.015Mixed Models Analysis
LS Mean Difference-5.995% CI-8.1-3.6p<0.001Mixed Models Analysis
LS Mean Difference-5.795% CI-7.8-3.6p<0.001Mixed Models Analysis
LS Mean Difference-6.295% CI-8.3-4.2p<0.001Mixed Models Analysis
Secondary/protocol endpoint

Change From Baseline in Body Weight

Time frame:Baseline, Week 26

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

10 endpoints
Primary/registry result

Change From Baseline in HbA1c in LY3502970 as Compared to Placebo

Time frame:Baseline, Week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

GroupValue (least_squares_mean), Percentage of HbA1c95% CI
3 mg LY3502970-1.19
12 mg LY3502970-1.91
24 mg LY3502970-1.79
36 mg LY3502970-2.03
45 mg LY3502970-2.10
Placebo-0.43
LS Mean Difference-0.7795% CI-1.13-0.40p<0.001Mixed Models Analysis
LS Mean Difference-1.4995% CI-1.85-1.12p<0.001Mixed Models Analysis
LS Mean Difference-1.3695% CI-1.75-0.98p<0.001Mixed Models Analysis
LS Mean Difference-1.6095% CI-1.96-1.25p<0.001Mixed Models Analysis
LS Mean Difference-1.6795% CI-2.02-1.32p<0.001Mixed Models Analysis
Primary/protocol endpoint

Change From Baseline in HbA1c in LY3502970 as Compared to Placebo

Time frame:Baseline, Week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result

Change From Baseline in HbA1c in LY3502970 as Compared to Dulaglutide

Time frame:Baseline, Week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

GroupValue (least_squares_mean), Percentage of HbA1c95% CI
3 mg LY3502970-1.19
12 mg LY3502970-1.91
24 mg LY3502970-1.79
36 mg LY3502970-2.03
45 mg LY3502970-2.10
1.5 mg Dulaglutide-1.10
LS Mean Difference-0.0995% CI-0.470.28p0.626Mixed Models Analysis
LS Mean Difference-0.8195% CI-1.18-0.44p<0.001Mixed Models Analysis
LS Mean Difference-0.6995% CI-1.08-0.30p<0.001Mixed Models Analysis
LS Mean Difference-0.9395% CI-1.29-0.57p<0.001Mixed Models Analysis
LS Mean Difference-1.0095% CI-1.36-0.64p<0.001Mixed Models Analysis
Secondary/registry result

Percentage of Participants With HbA1c ≤ 6.5%

Time frame:Week 26

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

GroupValue (number), Percentage of participants95% CI
3 mg LY350297045.30
12 mg LY350297070.73
24 mg LY350297080.12
36 mg LY350297079.39
45 mg LY350297083.52
Placebo14.56
1.5 mg Dulaglutide41.04
Odds Ratio (OR)6.7795% CI2.2120.75p<0.001Regression, Logistic
Odds Ratio (OR)34.0995% CI9.92117.16p<0.001Regression, Logistic
Odds Ratio (OR)48.3395% CI11.90196.24p<0.001Regression, Logistic
Odds Ratio (OR)45.7295% CI13.61153.64p<0.001Regression, Logistic
Odds Ratio (OR)77.2395% CI20.26294.48p<0.001Regression, Logistic
Odds Ratio (OR)1.2295% CI0.483.13p0.678Regression, Logistic
Odds Ratio (OR)6.1595% CI2.1917.24p<0.001Regression, Logistic
Odds Ratio (OR)8.7195% CI2.5529.79p<0.001Regression, Logistic
Odds Ratio (OR)8.2495% CI3.0522.30p<0.001Regression, Logistic
Odds Ratio (OR)13.9395% CI4.5143.01p<0.001Regression, Logistic
Secondary/registry result

Percentage of Participants With HbA1c <7.0%

Time frame:Week 26

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

GroupValue (number), Percentage of participants95% CI
3 mg LY350297065.17
12 mg LY350297078.92
24 mg LY350297091.24
36 mg LY350297092.75
45 mg LY350297095.76
Placebo24.27
1.5 mg Dulaglutide64.06
Odds Ratio (OR)8.1995% CI2.9322.90p<0.001Regression, Logistic
Odds Ratio (OR)25.0295% CI7.5782.69p<0.001Regression, Logistic
Odds Ratio (OR)62.3195% CI12.26316.63p<0.001Regression, Logistic
Odds Ratio (OR)67.5795% CI17.56259.97p<0.001Regression, Logistic
Odds Ratio (OR)129.5595% CI26.72628.09p<0.001Regression, Logistic
Odds Ratio (OR)1.1395% CI0.432.96p0.802Regression, Logistic
Odds Ratio (OR)3.4695% CI1.1610.31p0.026Regression, Logistic
Odds Ratio (OR)8.6195% CI1.8340.51p0.006Regression, Logistic
Odds Ratio (OR)9.3495% CI2.6732.71p<0.001Regression, Logistic
Odds Ratio (OR)17.9095% CI4.0279.70p<0.001Regression, Logistic
Secondary/registry result

Change From Baseline in Fasting Serum Glucose

Time frame:Baseline, Week 26

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

GroupValue (least_squares_mean), milligrams per deciliter (mg/dL)95% CI
3 mg LY3502970-32.6
12 mg LY3502970-53.7
24 mg LY3502970-52.2
36 mg LY3502970-53.9
45 mg LY3502970-55.9
Placebo-11.1
1.5 mg Dulaglutide-33.2
LS Mean Difference-21.595% CI-32.7-10.3p<0.001Mixed Models Analysis
LS Mean Difference-42.595% CI-53.4-31.7p<0.001Mixed Models Analysis
LS Mean Difference-41.095% CI-52.7-29.3p<0.001Mixed Models Analysis
LS Mean Difference-42.795% CI-53.5-32.0p<0.001Mixed Models Analysis
LS Mean Difference-44.795% CI-55.3-34.2p<0.001Mixed Models Analysis
LS Mean Difference0.695% CI-10.611.8p<0.001Mixed Models Analysis
LS Mean Difference-20.595% CI-31.4-9.5p<0.001Mixed Models Analysis
LS Mean Difference-19.095% CI-30.7-7.2p0.002Mixed Models Analysis
LS Mean Difference-20.795% CI-31.4-9.9p<0.001Mixed Models Analysis
LS Mean Difference-22.795% CI-33.2-12.1p<0.001Mixed Models Analysis
Secondary/protocol endpoint

Change From Baseline in HbA1c in LY3502970 as Compared to Dulaglutide

Time frame:Baseline, Week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participants With HbA1c ≤ 6.5%

Time frame:Week 26

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participants With HbA1c <7.0%

Time frame:Week 26

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change From Baseline in Fasting Serum Glucose

Time frame:Baseline, Week 26

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Safety / tolerability / PK

2 endpoints
Secondary/registry result

Pharmacokinetics (PK): Steady State Area Under the Concentration Curve (AUC) of LY3502970

Time frame:Pre-dose (Week (wk) 0, wk 8, wk 12, and wk 26); Post-dose (wk 4, wk 8, wk 16, wk 20, and end of treatment).

AUC₀–∞

concentration, descriptive

Posted result

GroupValue (geometric_mean), nanogram *hour per milliliter (ng*h/mL)95% CI
3 mg LY3502970364
12 mg LY35029701020
24 mg LY35029701500
36 mg LY3502970 - 11830
36 mg LY3502970 - 22430
45 mg LY3502970 - 12230
45 mg LY3502970 - 22550
Secondary/protocol endpoint

Pharmacokinetics (PK): Steady State Area Under the Concentration Curve (AUC) of LY3502970

Time frame:Pre-dose (Week (wk) 0, wk 8, wk 12, and wk 26); Post-dose (wk 4, wk 8, wk 16, wk 20, and end of treatment).

AUC₀–∞

concentration, descriptive

Publications (2)

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.

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableClinicalTrials.gov results section

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.