A Study of LY3502970 in Participants With Type 2 Diabetes Mellitus
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: LY3502970 Dose 1 Participants will receive escalated doses of LY3502970 administered orally |
Drug: LY3502970
Administered orally
|
Experimental: LY3502970 Dose 2 Participants will receive escalated doses of LY3502970 administered orally |
Drug: LY3502970
Administered orally
|
Experimental: LY3502970 Dose 3 Participants will receive escalated doses of LY3502970 administered orally |
Drug: LY3502970
Administered orally
|
Experimental: LY3502970 Dose 4 Participants will receive escalated doses of LY3502970 administered orally |
Drug: LY3502970
Administered orally
|
Experimental: LY3502970 Dose 5 Participants will receive escalated doses of LY3502970 administered orally |
Drug: LY3502970
Administered orally
|
Active Comparator: Dulaglutide Participants will receive Dulaglutide subcutaneously (SC) |
Drug: Dulaglutide
Administered subcutaneously
|
Placebo Comparator: Placebo Matching LY3502970 Participants will receive placebo matching LY3502970 orally |
Drug: Placebo
Administered orally
|
Placebo Comparator: Placebo Matching Dulaglutide Participants will receive placebo matching Dulaglutide subcutaneously |
Drug: Placebo
Administered subcutaneously
|
Outcome Measures
Primary Outcome Measures
- Change from Baseline in Hemoglobin A1c (HbA1c) in LY3502970 and Placebo [Baseline, Week 26]
Change from Baseline in HbA1c in LY3502970 and Placebo
Secondary Outcome Measures
- Change from Baseline in HbA1c in LY3502970 and Dulaglutide [Baseline, Week 26]
Change from Baseline in HbA1c in LY3502970 and Dulaglutide
- Percentage of Participants with HbA1c ≤ 6.5% [Week 26]
Percentage of Participants with HbA1c ≤ 6.5%
- Percentage of Participants with HbA1c <7.0% [Week 26]
Percentage of Participants with HbA1c <7.0%
- Percentage of Participants in Fasting Glucose [Week 26]
Percentage of Participants in Fasting Glucose
- Change from Baseline in Body Weight [Baseline, Week 26]
Change from Baseline in Body Weight
- Pharmacokinetics (PK): Steady State Area Under the Concentration Curve (AUC) of LY3502970 [Baseline through Week 26]
PK: Steady State AUC of LY3502970
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Anaheim Clinical Trials, LLC | Anaheim | California | United States | 92801 |
2 | Velocity Clinical Research, Huntington Park | Huntington Park | California | United States | 90255 |
3 | Velocity Clinical Research, Westlake | Los Angeles | California | United States | 90057 |
4 | Rancho Cucamonga Clinical Research | Rancho Cucamonga | California | United States | 91730 |
5 | Touro University California | Vallejo | California | United States | 94592 |
6 | New West Physicians Clinical Research | Golden | Colorado | United States | 80401 |
7 | Optumcare Colorado Springs - Monument | Monument | Colorado | United States | 80132 |
8 | Cotton O'Neil Clinical Research Center | Topeka | Kansas | United States | 66606 |
9 | Clinvest Research LLC | Springfield | Missouri | United States | 65807 |
10 | Premier Research | Trenton | New Jersey | United States | 08611 |
11 | Intend Research, LLC | Norman | Oklahoma | United States | 73069 |
12 | Capital Area Research, LLC | Camp Hill | Pennsylvania | United States | 17011 |
13 | Family Medical Associates | Levittown | Pennsylvania | United States | 19056 |
14 | Tristar Clinical Investigations | Philadelphia | Pennsylvania | United States | 19114 |
15 | Dallas Diabetes Research Center | Dallas | Texas | United States | 75230 |
16 | Biopharma Informatic, LLC | Houston | Texas | United States | 77084 |
17 | Bandera Family Health Care | San Antonio | Texas | United States | 78249 |
18 | Consano Clinical Research, LLC | Shavano Park | Texas | United States | 78231 |
19 | Capital Clinical Research Center | Olympia | Washington | United States | 98502 |
20 | Eastside Research Associates | Redmond | Washington | United States | 98052 |
21 | Bugát Pál Kórház | Gyongyos | Heves | Hungary | 3200 |
22 | Kanizsai Dorottya Korhaz | Nagykanizsa | Zala | Hungary | 8800 |
23 | Zala Megyei Szent Rafael Kórház | Zalaegerszeg | Zala | Hungary | 8900 |
24 | Szent Margit Rendelőintézet Nonprofit Kft | Budapest | Hungary | 1032 | |
25 | Clinexpert Kft. | Budapest | Hungary | 1033 | |
26 | ClinDiab Kft. | Budapest | Hungary | 1089 | |
27 | TRANTOR'99 Bt. Anyagcsere Centrum | Budapest | Hungary | 1213 | |
28 | Strazsahegy Medicina Bt. | Budapest | Hungary | H1171 | |
29 | Wojewódzki Zespól Specjalistycznej Opieki Zdrowotnej | Wrocław | Dolnośląskie | Poland | 50-403 |
30 | Gabinety TERPA | Lublin | Lubelskie | Poland | 20-333 |
31 | NZOZ Medica | Lublin | Lubelskie | Poland | 20-538 |
32 | Centralny Szpital Kliniczny MSWiA w Warszawie | Warszawa | Mazowieckie | Poland | 02-507 |
33 | Centrum Zdrowia Tuchów | Wierzchosławice | Małopolskie | Poland | 33-122 |
34 | Centrum Badan Klinicznych PI-House sp. z o.o. | Gdansk | Pomorskie | Poland | 80-546 |
35 | Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna | Lodz | Łódzkie | Poland | |
36 | NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki | Ruda Slaska | Śląskie | Poland | 41-709 |
37 | Dorado Medical Complex | Dorado | Puerto Rico | 00646 | |
38 | Clinical Research Management Group Inc. - Hospital San Cristobal | Ponce | Puerto Rico | 00780 | |
39 | BRCR Global Puerto Rico-Unda | San Juan | Puerto Rico | 00907 | |
40 | Ambulancia diabetológie a porúch látkovej premeny a výživy - DIABEDA | Bratislava | Bratislavský Kraj | Slovakia | 831 06 |
41 | Diabetol | Prešov | Prešovský Kraj | Slovakia | 080 01 |
42 | MEDI-DIA s.r.o. | Sabinov | Prešovský Kraj | Slovakia | 083 01 |
43 | DIA-MED CENTRUM s.r.o. | Puchov | Trenčiansky Kraj | Slovakia | 020 01 |
44 | Funkystuff | Nove Zamky | Slovakia | 940 01 |
Sponsors and Collaborators
- Eli Lilly and Company
Investigators
- Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 17787
- J2A-MC-GZGE
- 2021-002806-29