Study of LY3502970 for Adults with Obesity or Overweight and Type 2 Diabetes

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What is this study about?

This clinical trial is focused on studying the effects of a new treatment for adults who are either overweight or have obesity, and also have Type 2 Diabetes. The treatment being tested is an oral medication known as Orforglipron, which is also referred to by its code name, LY3502970. The purpose of the study is to determine if Orforglipron is more effective than a placebo in helping participants lose weight.

Participants in the study will take the medication in capsule form once a day. The study will compare the weight changes in participants taking Orforglipron to those taking a placebo over a period of time. The main goal is to observe the average percentage change in body weight from the start of the study to the end, which is expected to last until 2025.

This study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication and who is receiving the placebo. This helps ensure that the results are unbiased and reliable. The study aims to provide valuable information on the safety and effectiveness of Orforglipron for managing weight in individuals with Type 2 Diabetes who are overweight or have obesity.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria. Participants must be overweight or have excess weight, have a history of at least one unsuccessful dietary effort to lose weight, and have type 2 diabetes with stable treatment for at least 90 days prior to screening. Up to three oral anti-hyperglycemic medications may be taken.

2 randomization

Participants are randomly assigned to receive either the study medication, LY3502970, or a placebo. This process is double-blind, meaning neither the participants nor the researchers know who receives the actual medication or the placebo.

3 medication administration

The study involves taking the assigned medication orally in the form of a capsule. The medication is administered once daily. The placebo is designed to match the appearance of the LY3502970 capsule.

4 monitoring and assessments

Throughout the study, participants undergo regular monitoring and assessments to evaluate the efficacy and safety of the treatment. The primary focus is on the mean percent change in body weight from baseline to week 72.

5 completion of the study

The study is estimated to conclude by September 19, 2025. At the end of the study, final assessments are conducted to determine the overall outcomes and any changes in body weight.

Who Can Join the Study?

Be overweight or have excess weight.
Have a history of at least one self-reported unsuccessful attempt to lose weight through diet.
Have type 2 diabetes and be on stable treatment for at least 90 days before the screening. Type 2 diabetes is a condition where the body has trouble using insulin properly, leading to high blood sugar levels.
Have been taking up to three oral medications to help control blood sugar levels, known as anti-hyperglycemic medications.
Both male and female participants are eligible.

Who Cannot Join the Study?

Individuals who are not within the specified age range for the study.
Individuals who do not have the medical conditions being studied, such as Overweight, Obesity, or Type 2 Diabetes.
Individuals who are part of a vulnerable population that the study is not designed to include.
Individuals who do not meet other specific health criteria set by the study organizers.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Gemeinschaftspraxis Drs. Josef und Wilma Großkopf	Wallerfing	Germany
Diabetes-Zentrum-Wilhelmsburg GbR	Hamburg	Germany

Other Sites

Site Name	City	Country
General University Hospital Of Larissa	Larissa	Greece
University Of Luebeck	Luebeck	Germany
General Hospital Of Thessaloniki Papageorgiou	Thessaloniki	Greece
Diabet2 s.r.o.	Prague	Czechia
Euromedica General Clinic Of Thessaloniki	Thessaloniki	Greece
InnoDiab Forschung GmbH	Essen	Germany
R.E.D. Institut fuer medizinische Studien und Fortbildung GmbH	Oldenburg In Holstein	Germany
Thermi Clinic S.A.	Thessaloniki	Greece
Medizentrum Essen Borbeck	Essen	Germany
Ippokratio General Hospital Of Thessaloniki	Thessaloniki	Greece
Smo Md GmbH	Magdeburg	Germany
424 Military General Training Hospital	Thessaloniki	Greece
MuDr. Jitka Zemanova Diabetologie A Interna s.r.o.	Plzen 2-Slovany	Czechia
MUDr. Alena Vachova	Ceske Budejovice	Czechia
Ambenet GmbH Das Ambulante Behandlungsnetz	Leipzig	Germany
Diabetologische Schwerpunktpraxis Pirna	Pirna	Germany
Athens Medical Center S.A.	Athens	Greece
Institut fuer Diabetesforschung Muenster GmbH	Munster	Germany
MVZ Diabeteszentrum Dr. Tews GmbH	Gelnhausen	Germany
Diahelp s.r.o.	Pardubice	Czechia
Universität zu Lübeck – Institut für Endokrinologie und Diabetes	Luebeck	Germany
colmrbtgouaqu	Pohlheim	Germany
Eeqmuwodofswuv Mavhw Řueifxbzb suhzxp	Hradec Kralove	Czechia
Mpgmg Sowxpc Ptxdsx	Jílové u Prahy	Czechia
Njcvijjle Čincf Kynscqgk aiti	Český Krumlov	Czechia
Rvsqmjzp sohpdv	Prague	Czechia
Mwqke Taitg Efnifgxvctp	Krnov	Czechia
Ugavowfffb Hremrszg Cuepmvo	Cologne	Germany
Gizjnysspxhfsqgvebr Drdph Dgnzot &wrcw Pmdypdac	Friedrichsthal	Germany
Cgv Sogjbalahrorvfn Hyglpsb	Munich	Germany
Huuvwjwpd &mlfl Dxoiynratqwzbhvnzcmvneolna Hjmjwwrypuj	Hohenmölsen	Germany
Damynba sjduaf	Plzen	Czechia
Mjofs Kqnwqs spoaqg	Dobris	Czechia

Trial status

Country	Status	Recruitment Start
Czechia	Not recruiting	02.10.2023
Germany	Not recruiting	02.10.2023
Greece	Not recruiting	02.10.2023

Trial locations

LY3502970 is an investigational medication being studied for its potential to help reduce body weight in adults who are overweight or have obesity and also have type 2 diabetes. The trial aims to determine if this medication is more effective than a placebo in achieving weight loss.

Investigated diseases:

Overweight – Overweight is a condition where an individual has more body weight than is considered healthy for their height. It is often measured using the Body Mass Index (BMI), which calculates weight in relation to height. Overweight can result from a combination of factors, including poor diet, lack of physical activity, and genetic predisposition. It can lead to increased fat accumulation in the body, which may affect overall health. Over time, being overweight can contribute to the development of other health issues, such as cardiovascular diseases and metabolic disorders.

Obesity – Obesity is a medical condition characterized by excessive body fat accumulation that may negatively impact health. It is typically assessed using the Body Mass Index (BMI), with a BMI of 30 or higher indicating obesity. The condition results from a combination of genetic, behavioral, and environmental factors, including high-calorie diets and sedentary lifestyles. Obesity can lead to various health complications, such as heart disease, type 2 diabetes, and certain cancers. It often progresses gradually, with weight gain occurring over time due to an imbalance between calorie intake and energy expenditure.

Type 2 Diabetes – Type 2 Diabetes is a chronic condition that affects the way the body processes blood sugar (glucose). It occurs when the body becomes resistant to insulin or when the pancreas fails to produce enough insulin. This leads to elevated levels of glucose in the blood, which can cause various health issues if not managed properly. The condition often develops gradually, with symptoms such as increased thirst, frequent urination, and fatigue. Over time, type 2 diabetes can lead to complications affecting the heart, kidneys, eyes, and nerves.

Trial ID:

2022-502837-24-00

Protocol code:

J2A-MC-GZGQ

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of LY3502970 for Adults with Obesity or Overweight and Type 2 Diabetes

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