DRUG
LY3502970
Administered orally
A Study of LY3502970 in Participants With Type 2 Diabetes Mellitus
Status
Completed
Phase
Phase 2
Enrollment
383
Locations
44
Results
Posted
Publications
2
Study summary
What the protocol is testing.
The main purpose of this study is to evaluate the efficacy and safety of LY3502970 in participants with type 2 diabetes (T2D) who failed to achieve adequate glycemic control on diet and exercise alone or on a stable dose of metformin. This study will last about 30 weeks.
Interventions
Treatment arms and agents.
DRUG
Dulaglutide
Administered subcutaneously
DRUG
Placebo
Administered orally
DRUG
Placebo
Administered subcutaneously
Timeline
From registration to results.
First posted
Sep 17, 2021
Study start
Sep 15, 2021
Primary completion
Sep 30, 2022
Study completion
Sep 30, 2022
Results posted
Oct 17, 2023
Registry updated
Oct 17, 2023
Outcomes
What the study measures.
Primary outcomes
Change From Baseline in HbA1c in LY3502970 as Compared to Placebo
Time frame · Baseline, Week 26
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed model repeated measures (MMRM) model with Baseline + Country + Baseline HbA1c Group (\<=8.0%, \>8.0%) + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Secondary outcomes
Change From Baseline in HbA1c in LY3502970 as Compared to Dulaglutide
Time frame · Baseline, Week 26
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed model repeated measures (MMRM) model with Baseline + Country + Baseline HbA1c Group (\<=8.0%, \>8.0%) + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Percentage of Participants With HbA1c ≤ 6.5%
Time frame · Week 26
Percentage of Participants with HbA1c ≤ 6.5%. Odds ratio was calculated using logistic regression model.
Percentage of Participants With HbA1c <7.0%
Time frame · Week 26
Percentage of Participants with HbA1c \<7.0%. Odds ratio was calculated using logistic regression model.
Change From Baseline in Fasting Serum Glucose
Time frame · Baseline, Week 26
Fasting glucose is a test to determine sugar levels in blood sample after an overnight fast. LS mean was determined by MMRM model with Baseline + Country + Baseline HbA1c Group (\<=8.0%, 8.0%) + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Change From Baseline in Body Weight
Time frame · Baseline, Week 26
LS mean was determined by MMRM model with Baseline + Country + Baseline HbA1c Group (\<=8.0%, \>8.0%) + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
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).
PK: Steady State AUC of LY3502970
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Sex
- ALL
- Healthy volunteers
- No
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
Study locations
44 registered sites.
Hungary · Poland · Puerto Rico · Slovakia · United States. Showing up to 24 locations stored in the fast local snapshot.
Anaheim Clinical Trials, LLC
Anaheim, California, United States
Velocity Clinical Research, Huntington Park
Huntington Park, California, United States
Velocity Clinical Research, Westlake
Los Angeles, California, United States
Rancho Cucamonga Clinical Research
Rancho Cucamonga, California, United States
Touro University California
Vallejo, California, United States
New West Physicians Clinical Research
Golden, Colorado, United States
Optumcare Colorado Springs - Monument
Monument, Colorado, United States
Cotton O'Neil Clinical Research Center
Topeka, Kansas, United States
Clinvest Research LLC
Springfield, Missouri, United States
Premier Research
Trenton, New Jersey, United States
Intend Research, LLC
Norman, Oklahoma, United States
Capital Area Research, LLC
Camp Hill, Pennsylvania, United States
Family Medical Associates
Levittown, Pennsylvania, United States
Tristar Clinical Investigations
Philadelphia, Pennsylvania, United States
Dallas Diabetes Research Center
Dallas, Texas, United States
Biopharma Informatic, LLC
Houston, Texas, United States
Bandera Family Health Care
San Antonio, Texas, United States
Consano Clinical Research, LLC
Shavano Park, Texas, United States
Capital Clinical Research Center
Olympia, Washington, United States
Eastside Research Associates
Redmond, Washington, United States
Bugát Pál Kórház
Gyöngyös, Heves County, Hungary
Kanizsai Dorottya Korhaz
Nagykanizsa, Zala County, Hungary
Zala Megyei Szent Rafael Kórház
Zalaegerszeg, Zala County, Hungary
Szent Margit Rendelőintézet Nonprofit Kft
Budapest, Hungary
Publications
Results and literature.
PMID 40481478 ↗Wharton S, Rosenstock J, Konige M, Lin Y, Duffin K, Wilson J, Banerjee H, Pirro V, Kazda C, Mather K. Treatment with orforglipron, an oral glucagon like peptide-1 receptor agonist, is associated with improvements of CV risk biomarkers in participants with type 2 diabetes or obesity without diabetes. Cardiovasc Diabetol. 2025 Jun 6;24(1):240. doi: 10.1186/s12933-025-02781-x.PMID 37369232 ↗Frias JP, Hsia S, Eyde S, Liu R, Ma X, Konig M, Kazda C, Mather KJ, Haupt A, Pratt E, Robins D. Efficacy and safety of oral orforglipron in patients with type 2 diabetes: a multicentre, randomised, dose-response, phase 2 study. Lancet. 2023 Aug 5;402(10400):472-483. doi: 10.1016/S0140-6736(23)01302-8. Epub 2023 Jun 24.
Related trials
More studies on Dulaglutide.
NCT IDStudyPhase / statusEnrollmentUpdated
Determination of Resistance Training Status for Patients on Glucagon-Like Peptide-1 Receptor Agonists
Ohio State University · Obesity & Overweight · Diabetes (DM)
Not applicable
Recruiting
300
2026-07
A Study of Dulaglutide (LY2189265) 3.0 mg and 4.5 mg in Pediatric Participants With Type 2 Diabetes Mellitus (AWARD-PEDS PLUS)
Eli Lilly · Type 2 Diabetes
Phase 3
Recruiting
55
2026-07
A Study of Orforglipron (LY3502970) Compared With Dulaglutide in Pediatric Participants With Type 2 Diabetes
Eli Lilly · Diabetes Mellitus, Type 2
Phase 3
Not yet recruiting
170
2026-07
Emulation of the REWIND Cardiovascular Outcomes Trial in Healthcare Claims Data.
Brigham and Women's Hospital · Type 2 Diabetes
Not applicable
Completed
300,000
2026-07
INcreTin-based thERapies for Cardiovascular Event PrevenTion in Patients With and Without ASCVD (INTERCEPT-ASCVD)
Brigham and Women's Hospital · Type 2 Diabetes · Overweight
Not applicable
Completed
60,000
2026-07
Injectable Semaglutide vs Dulaglutide in Individuals at Cardiovascular Risk
Brigham and Women's Hospital · Type 2 Diabetes Mellitus · Obesity
Not applicable
Completed
120,000
2026-07
A Study of Tirzepatide (LY3298176) Compared With Dulaglutide on Major Cardiovascular Events in Participants With Type 2 Diabetes
Eli Lilly · Type 2 Diabetes Mellitus
Phase 3
Completed
13,299
2026-07
Phase II Study of Switching From Dulaglutide to PG-102(MG12) in Type 2 Diabetes Mellitus
ProGen. Co., Ltd. · Type 2 Diabetes
Phase 2
Not yet recruiting
60
2026-07
Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.