Evaluating Once Daily Orforglipron (LY3502970) Compared to Insulin Glargine in Adults with Type 2 Diabetes and Obesity or Overweight who Have Increased Cardiovascular Risk

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What is this study about?

This clinical trial is investigating orforglipron (also called LY3502970) compared to insulin glargine in adults who have Type 2 Diabetes along with obesity or being overweight and who are at increased risk for cardiovascular (heart and blood vessel) problems. Type 2 Diabetes is a condition where the body doesn’t use insulin properly, resulting in high blood sugar levels. People in this study will have evidence of heart disease and will already be taking diabetes medications.

The purpose of this study is to determine if daily oral orforglipron is as effective as insulin glargine (an injectable insulin) in preventing major heart-related events in these patients. The study will look at outcomes such as myocardial infarction (heart attack), stroke, hospitalization for unstable angina (chest pain), and death related to heart disease.

This is a Phase 3, open-label study, which means participants and researchers will know which treatment is being given. Participants will either take orforglipron once daily by mouth or use insulin glargine injections while continuing their existing diabetes medications. The study will monitor their health status over time to compare the safety and effectiveness of these two treatment approaches.

1 Starting the Study

After joining the study, you will be randomly assigned to receive either orforglipron (LY3502970) taken by mouth once daily as a capsule or insulin glargine (Abasaglar) as an injectable solution using a pre-filled pen.

You will continue taking your current diabetes medications (1 to 3 oral medications) that you have been taking for at least 3 months before joining the study.

2 Treatment Period

If assigned to the orforglipron group, you will take a daily oral capsule of orforglipron. The exact dosage is not specified in the provided information.

If assigned to the insulin glargine group, you will use Abasaglar 100 units/mL KwikPen solution for injection. The dosage will be determined by your study doctor based on your blood sugar levels.

Throughout the treatment period, you will continue to take your background diabetes medications such as metformin, empagliflozin, canagliflozin, dapagliflozin, or ertugliflozin as prescribed before the study.

3 Regular Monitoring

You will have regular check-ups where your blood sugar levels will be monitored, including hemoglobin A1C (HbA1c) tests. This is a blood test that shows your average blood sugar level over the past 2-3 months.

Your heart health will be monitored throughout the study to track any cardiovascular events. These include heart attacks (myocardial infarction), strokes, hospitalization for unstable chest pain (unstable angina), or heart-related death.

4 Study Duration

The study begins on July 5, 2023, and is scheduled to end on August 27, 2025. You may participate for all or part of this period depending on when you join the study.

The exact duration of your participation will depend on the study protocol and your individual situation.

5 Study Completion

At the end of your participation, you will have a final assessment to evaluate the effects of the treatment on your diabetes and heart health.

After completing the study, your doctor will discuss appropriate options for continuing your diabetes management outside of the study.

Who Can Join the Study?

  • Have Type 2 Diabetes
  • Be taking a consistent dose of 1 to 3 diabetes medications by mouth for the last 3 months
  • Have heart disease (cardiovascular disease)
  • Have high blood sugar as measured by hemoglobin A1C (HbA1c) of at least 7.0% (this is a blood test that shows your average blood sugar levels over the past 2-3 months)
  • Be overweight or obese (having a body weight higher than what is considered healthy for a given height)

Who Cannot Join the Study?

  • If you have a heart attack, stroke, hospitalization for unstable chest pain (angina), or death due to heart disease in the past 60 days.
  • If you have experienced dangerously low blood sugar levels (severe hypoglycemia) in the past 6 months.
  • If you have had diabetic ketoacidosis (a serious complication where your body produces high levels of blood acids) in the past year.
  • If you have been diagnosed with Type 1 diabetes (a condition where your body doesn’t produce any insulin).
  • If you have severe liver problems or severe kidney disease requiring dialysis.
  • If you have had pancreatitis (inflammation of the pancreas) or pancreatic injury.
  • If you have a personal or family history of a specific type of thyroid cancer called medullary thyroid carcinoma.
  • If you have Multiple Endocrine Neoplasia syndrome type 2 (a rare condition that causes tumors in the endocrine glands).
  • If you are currently using certain medications like other GLP-1 receptor agonists (medications that work similar to the study drug).
  • If you have a history of gastroparesis (delayed stomach emptying).
  • If you are pregnant, planning to become pregnant, or breastfeeding.
  • If you have participated in another clinical trial within the past 30 days.
  • If you have any condition that the study doctor believes would make it unsafe for you to participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Azienda Ospedaliera Universitaria Federico II Di Napoli Naples Italy
Medical University Of Graz Graz Austria
Schwerpunktpraxis für Diabetes Hormone & Stoffwechsel Hof Germany
DIACENTRUM Brandys n.L. s.r.o. Brandys Nad Labem Czechia
MVZ im Altstadt-Carree Fulda GmbH Fulda Germany
Medic-Center Nürnberg Nürnberg Germany
Medical University Of Vienna Vienna Austria
IN DIA s.r.o. Lučenec Slovakia
Gesundheitsverbund Landkreis Konstanz gGmbH Singen (Hohentwiel) Germany
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Diabetespraxis Dr. Braun Berlin Germany
Praxis am Markt Essen Germany

Other Sites

Site Name City Country Status
Hospital Nisa Sevilla Aljarafe Castilleja De La Cuesta Spain
Cardiomed S.R.L. Iasi Romania
Praglandia s.r.o. Prague Czechia
Areteus s.r.o. Trebisov Slovakia
Nuevas Tecnologias En Diabetes Y En Endocrinologia S.L. Profesional Sevilla Spain
Ospedale San Raffaele S.r.l. Milan Italy
Hospital Universitario Quironsalud Madrid Pozuelo De Alarcon Spain
Klinik Hietzing Vienna Austria
Azienda Ospedaliero-Universitaria Maggiore Della Carita Novara Italy
A.O. Krankenhaus St. Josef Braunau GmbH Braunau Am Inn Austria
Hospital General De Segovia Segovia Spain
Hightech Medical Services S.R.L. Bucharest Romania
Human-Care s.r.o. Kosice Slovakia
MEDICON a.s. Prague Czechia
Hospital Universitario Central De Asturias Oviedo Spain
Consultmed S.R.L. Iasi Romania
Azienda Sanitaria Universitaria Giuliano Isontina Trieste Italy
Università degli studi Gabriele D’Annunzio Chieti-Pescara Centro di Studi e tecnologie avanzate Chieti Italy
Hospital Universitario Reina Sofía Cordoba Spain
Praxis für Diabetologie, Angiologie und Innere Medizin Eisenach Eisenach Germany
TreDia s.r.o. Prague Czechia
Virgen del Rocío University Hospital Sevilla Spain
Hospital Ruber Juan Bravo Madrid Spain
PreventaMed s.r.o. Olomouc Czechia
Hospital Santa Maria Della Misericordia Perugia Italy
Klinik Landstrasse Vienna Austria
Nutrilife S.R.L. Bucharest Romania
R.E.D. Institut fuer medizinische Studien und Fortbildung GmbH Oldenburg In Holstein Germany
Societatea Civila Medicala Dr. Paveliu Bucharest Romania
Nicodiab S.R.L. Bucharest Romania
Clinica Korall S.R.L. Satu Mare Romania
Milena Sante S.R.L. Galati Romania
Hospital Universitario De La Ribera Alzira Spain
Zentrum Fur Klinische Studien Dr. Hanusch GmbH Vienna Austria
Cabinet Medical Dr Geru S.R.L. Timisoara Romania
Mariodiab Clinic S.R.L. Brasov Romania
Mediab S.R.L. Targu Mures Romania
Grandmed S.R.L. Oradea Romania
Diamed Obesity S.R.L. Galati Romania
JAL s.r.o. Trnava Slovakia
Nemocnice Cesky Krumlov a.s. Horni Brana Czechia
General Hospital Of Lamia Lamia Greece
VIVIT Feldkirch Austria
DIA MED CENTRUM s.r.o. Zilina Slovakia
Smo Md GmbH Magdeburg Germany
Edumed s.r.o. Nachod Czechia
DIAB s.r.o. Roznava Slovakia
General Hospital Of Thessloniki G Gennimatas Thessaloniki Greece
Medi-Dia s.r.o. Sabinov Slovakia
Sc Cmi Dr. Pletea Noemi S.R.L. Bacau Romania
Diabdana S.R.L. Oradea Romania
Narodny Endokrinologicky A Diabetologicky Ustav Lubochna Slovakia
Diabint s.r.o. Bytca Slovakia
Private Practice – Dr. Evelyn Fließer-Görzer St. Stefan ob Stainz Austria
Aidin VK s.r.o. Hranice I-Mesto Czechia
Fledip s.r.o. Prague Czechia
Nefromed s.r.o. Prague Czechia
MUDr. Michala Pelikanova s.r.o. Prague Czechia
MVZ Diabeteszentrum Dr. Tews GmbH Gelnhausen Germany
Metabol KLINIK s.r.o. Stare Mesto Slovakia
Edumed s.r.o. Nove Mesto Czechia
Diahelp s.r.o. Pardubice Czechia
Mehspkf Sdkctj Bacau Romania
Hcbwhyyz Ubbbgdilvkewj Mcxtdfn Dy Vslxnrhccl Santander Spain
Daounumzjqwqanl Sfnejyuhripepxauy Meney Lfqa Pwvdue Pohlheim Germany
Gfghppynigvreodjiiq Dmq Teacmloys / Den Blpnjpb Leipzig Germany
Cwlzuem fcq Daguuxjhqucc uig Asixezznyutxflqc Pohlheim Germany
Dedqrzy shueyf Ruzinov Slovakia
Etaxaem hregzataen suicnd Brno Czechia
Mcina Mehkbvgh Kgodym sjasmm Ostrava Czechia
Evkppggm Shnqle Bucharest Romania
Acmhwe Mllnzob Cyhxln Shsa Paleo Faliro Greece
Lcpsg Gbabzmp Hssnhffy Oi Arvqpl Athens Greece
Mpjba Tlnxn Epzrajlhxkg Krnov Czechia
Alymgqa Odbntfheowy Unqemizgsjqps Sgyjei Siena Italy
Dcmkfeg Dye Ptxldyv Afcrjswzygp Serznr Ploiesti Romania
Ubhytsqmwp Mqrds Gvlslsy Og Chrczkpjf Catanzaro Italy
Czpklzv Mvcxkaf Dh Dvciffrjom So Tvywgqrmv Abuzomfes Noqsdg Sekcwe Brasov Romania
Mjxxaod sylvhs Malacky Slovakia
Peieeo Hpnpizg Mühldorf am Inn Germany
Hinjdidf Ulvwaflrcxijb dc A Cpivqy A Coruna Galicia Spain
Usdezqgvdn Gzaqmqn Hktlaukl Arkrozu Athens Greece
Kkqdydu Ddq Bgnuzzcgdpcl Bmwirzy Linz Austria
Dmnmvxh sifqzx Plzen Czechia
Mwjwu Kdmdva scscjn Dobris Czechia

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
05.07.2023
Czechia Czechia
Not recruiting
05.07.2023
Germany Germany
Not recruiting
05.07.2023
Greece Greece
Not recruiting
05.07.2023
Italy Italy
Not recruiting
05.07.2023
Romania Romania
Not recruiting
05.07.2023
Slovakia Slovakia
Not recruiting
05.07.2023
Spain Spain
Not recruiting
05.07.2023

Trial locations

LY3502970 is a once-daily medication being studied for people with type 2 diabetes who also have obesity or are overweight and at increased risk for cardiovascular problems. It is an experimental treatment that is being tested to see how it affects blood sugar control and cardiovascular outcomes.

Insulin Glargine is a long-acting insulin that is injected once daily to help control blood sugar levels throughout the day and night. It works by helping glucose (sugar) enter cells to be used for energy. It is a standard treatment for people with type 2 diabetes.

Type 2 Diabetes – A chronic metabolic disorder characterized by high blood sugar levels due to insulin resistance and insufficient insulin production. The body either resists the effects of insulin or doesn’t produce enough insulin to maintain normal glucose levels. It develops gradually, often beginning with insulin resistance where cells don’t respond properly to insulin. Risk factors include being overweight, physical inactivity, and genetic predisposition.

Cardiovascular Disease – A class of diseases involving the heart and blood vessels. It includes conditions such as coronary artery disease, heart failure, arrhythmias, and valve disorders. These conditions develop when plaque builds up in the walls of arteries, narrowing them and making it harder for blood to flow through. The process often occurs over many years and can affect various parts of the circulatory system.

Chronic Kidney Disease – A condition characterized by gradual loss of kidney function over time. The kidneys filter wastes and excess fluids from the blood, which are then excreted in urine. When chronic kidney disease reaches an advanced stage, dangerous levels of fluid, electrolytes, and wastes can build up in the body. The disease progresses through five stages of decreasing kidney function.

Obesity – A complex disease involving an excessive amount of body fat. It’s defined as having a body mass index (BMI) of 30 or higher. Obesity occurs when a person consumes more calories than they burn through normal daily activities and exercise. It increases the risk of other health problems and is associated with poorer metabolic health.

Myocardial Infarction – Commonly known as a heart attack, it occurs when blood flow to a part of the heart is blocked, causing damage to the heart muscle. The blockage is most often a buildup of fat, cholesterol, and other substances that form a plaque in the coronary arteries. The plaque can rupture and form a clot that blocks blood flow.

Stroke – A condition where poor blood flow to the brain results in cell death. There are two main types: ischemic, due to lack of blood flow, and hemorrhagic, due to bleeding. It can cause parts of the brain to become damaged or die, affecting body functions controlled by those areas. Symptoms can include sudden numbness, confusion, trouble seeing or walking, and severe headache.

Trial ID:
2022-502833-25-00
Protocol code:
J2A-MC-GZGS
Trial Phase:
Therapeutic confirmatory (Phase III)

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