Boehringer Ingelheim — Biomedical Watch V2

Traitements21programmes

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Traitements

Molécule	Indication / population	Phase	Objectif	Pays	Résultat
BI 3000202This study is open to adults with systemic lupus erythematosus (SLE). The purpose of this study is to find out whether a medicine called BI 3000202 helps people with SLE. The study tests different doses of BI 3000202 and aims to find the best dose for people with this condition. Participants are put into 5 groups randomly, which means by chance. 4 groups get different doses of BI 3000202, and 1 group gets a placebo. Placebo tablets look like BI 3000202 tablets but do not contain any medicine. Participants take the tablets for 1 year. All participants also continue their regular treatment for SLE. Participants are in the study for a bit longer than 1 year. During this time, they visit the study site regularly. Doctors check the participants' health and take note of any unwanted effects. They also compare the results between the groups to see if the treatment works.	Lupus	Phase 2	À vérifier	United States, Argentina, Australia, Brazil, Bulgaria, China, Colombia, Croatia, …	À vérifier
BI 690517This study is open to adults with chronic kidney disease at risk of progression. People with and without type 2 diabetes can take part in this study. The study is open to people who take other medicines called angiotensin converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARB). People who already take empagliflozin or any other sodium-glucose cotransporter-2 inhibitor (SGLT2i) can also join. The study is also open to people who currently do not take any of these treatments. The purpose of this study is to find out whether a medicine called BI 690517 helps people with chronic kidney disease when taken in combination with a study medicine called empagliflozin. Worsening of kidney function increases the risk for kidney failure, cardiovascular disease, and heart failure hospitalisation. After a run-in period, during which participants are confirmed to be receiving clinically appropriate renin-angiotensin system blockade and are established on empagliflozin, they are randomly assigned (by chance) to 1 of 2 groups. One group receives BI 690517 tablets, and the other group receives placebo tablets. Placebo tablets look like BI 690517 but do not contain any medicine. Participants take 1 study tablet once a day, in addition to empagliflozin, for the duration of the study. The doctors document when participants experience worsening of their kidney disease, go to hospital due to heart failure, or die of cardiovascular problems during the study. The time to these events is compared between the 2 treatment groups to see whether the treatment works. The study continues until the required number of events have occurred which is about 3 to 4 years. During this time, participants visit the study site about 5 times within the first 6 months. Then they visit the study site every 6 months. At the visits, doctors regularly check participants' health, take blood and urine samples, measure blood pressure and weight, check kidney function, and take note of any unwanted effects.	Maladie rénale chronique	Phase 3	Ralentissement de la progression	United States, Argentina, Australia, Belgium, Brazil, Canada, China, Denmark, …	À vérifier
BIIL 284 BSTo evaluate the effect of multiple doses of BIIL 284 BS on the pharmacokinetics of a single dose of theophylline.	SEP	Phase 1	À vérifier		À vérifier
EmpagliflozinThe purpose of this study is to find out what effects (good and bad) the study medications (insulin or Empagliflozin) have on adults with mild memory impairment or early Alzheimer's disease who are clinically prescribed an anti-amyloid therapy compared to placebo.	Alzheimer, Hypertension, Insuffisance cardiaque, Maladie rénale chronique	Phase 3	À vérifier	United States, Argentina, Australia, Belgium, Canada, France, Germany, Hungary, …	À vérifier
NerandomilastThis study is open to adults aged 18 and older who have a condition known as active idiopathic inflammatory myopathy (IIM) or myositis. People can participate if they have a specific type of myositis. The purpose of this study is to find out whether a medicine called nerandomilast improves IIM symptoms. Participants are put into 2 groups randomly, which means by chance. One group takes nerandomilast tablets and the other group takes placebo tablets. Placebo tablets look like nerandomilast tablets but do not contain any medicine. Participants take nerandomilast or placebo twice a day for 1 year. Participants are in the study for about 1 year and 2 months. During this time, they visit the study site at least 16 times. During this time, doctors regularly check the participant's health, IIM symptoms, and take note of any unwanted effects. Participants fill in questionnaires about their IIM symptoms and how IIM impacts their quality of life. The results are compared between the 2 groups to see whether the treatment works.	Myopathies	Phase 3	Immunomodulation + Traitement symptomatique	United States, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, China, …	À vérifier
SurvodutideThis study is for adults aged 18 years and older who have a type of fatty liver disease called metabolic dysfunction-associated steatotic liver disease (MASLD). People can take part if their body mass index (BMI) is 27 kg/m² or higher, and they have certain heart and blood vessel risk factors. The purpose of this study is to find out how a medicine called survodutide affects heart structure and function in people with MASLD. Participants are put into 2 groups randomly, which means by chance. One group gets survodutide as an injection under the skin of the abdomen once a week. The other group gets placebo as an injection once a week. Placebo looks like survodutide but does not contain any medicine. The first injection is given at the study site. Later injections are usually given by the participants themselves at home using pre-filled syringes. Participants and doctors do not know who is getting survodutide or placebo. Participants are in the study for up to 1.5 years. During this time, they visit the study site about 14 times and have about 4 phone calls with the study staff. At some of the visits, doctors use ultrasound scans to check the heart. The results are compared between the 2 groups to see if survodutide helps improve the health of the heart. The study staff also regularly check participants' health and take note of any health problems.	Maladie coronarienne, Maladie rénale chronique	Phase 3	À vérifier	United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, …	À vérifier
VicadrostatThis study is open to adults with type 2 diabetes, high blood pressure, and cardiovascular disease. People can join the study if they have these conditions and do not have a history of heart failure. The purpose of this study is to find out if a medicine called vicadrostat, when taken with empagliflozin, helps reduce cardiovascular risk in people with these conditions. The study will compare this combination to a placebo version of vicadrostat with empagliflozin. Participants are put into 2 groups randomly, which means by chance. One group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets with empagliflozin. Placebo tablets look like vicadrostat tablets but do not contain any medicine. Participants take a tablet once per day for 2 and a half years and up to 4 years and 3 months. All participants also continue their medication for type 2 diabetes, high blood pressure, and cardiovascular disease. Participants have an equal chance of receiving the study medicine or placebo. Participants are in the study for up to 4 years and 3 months. During this time, they visit the study site regularly. During these visits, doctors collect information about participants' health and take blood samples. The doctors document when participants experience cardiovascular events. The doctors also regularly check participants' health and take note of any unwanted effects.	Hypertension, Insuffisance cardiaque	Phase 3	À vérifier	United States, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, …	À vérifier
EmpagliflozinThe purpose of this study is to find out what effects (good and bad) the study medications (insulin or Empagliflozin) have on adults with mild memory impairment or early Alzheimer's disease who are clinically prescribed an anti-amyloid therapy compared to placebo.	Alzheimer	Phase 2	À vérifier	United States	À vérifier
BI 3000202This study is open to adults with systemic lupus erythematosus (SLE). The purpose of this study is to find out whether a medicine called BI 3000202 helps people with SLE. The study tests different doses of BI 3000202 and aims to find the best dose for people with this condition. Participants are put into 5 groups randomly, which means by chance. 4 groups get different doses of BI 3000202, and 1 group gets a placebo. Placebo tablets look like BI 3000202 tablets but do not contain any medicine. Participants take the tablets for 1 year. All participants also continue their regular treatment for SLE. Participants are in the study for a bit longer than 1 year. During this time, they visit the study site regularly. Doctors check the participants' health and take note of any unwanted effects. They also compare the results between the groups to see if the treatment works.	Lupus	Phase 2	À vérifier	United States, Argentina, Australia, Brazil, Bulgaria, China, Colombia, Croatia, Germany, Hungary, India, Japan, Mexico, Netherlands, Poland, Romania, Serbia, South Africa, Spain, Taiwan, …	À vérifier
VicadrostatThis study is open to adults with type 2 diabetes, high blood pressure, and cardiovascular disease. People can join the study if they have these conditions and do not have a history of heart failure. The purpose of this study is to find out if a medicine called vicadrostat, when taken with empagliflozin, helps reduce cardiovascular risk in people with these conditions. The study will compare this combination to a placebo version of vicadrostat with empagliflozin. Participants are put into 2 groups randomly, which means by chance. One group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets with empagliflozin. Placebo tablets look like vicadrostat tablets but do not contain any medicine. Participants take a tablet once per day for 2 and a half years and up to 4 years and 3 months. All participants also continue their medication for type 2 diabetes, high blood pressure, and cardiovascular disease. Participants have an equal chance of receiving the study medicine or placebo. Participants are in the study for up to 4 years and 3 months. During this time, they visit the study site regularly. During these visits, doctors collect information about participants' health and take blood samples. The doctors document when participants experience cardiovascular events. The doctors also regularly check participants' health and take note of any unwanted effects.	Hypertension	Phase 3	À vérifier	United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czechia, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, …	À vérifier
NerandomilastThis study is open to adults aged 18 and older who have a condition known as active idiopathic inflammatory myopathy (IIM) or myositis. People can participate if they have a specific type of myositis. The purpose of this study is to find out whether a medicine called nerandomilast improves IIM symptoms. Participants are put into 2 groups randomly, which means by chance. One group takes nerandomilast tablets and the other group takes placebo tablets. Placebo tablets look like nerandomilast tablets but do not contain any medicine. Participants take nerandomilast or placebo twice a day for 1 year. Participants are in the study for about 1 year and 2 months. During this time, they visit the study site at least 16 times. During this time, doctors regularly check the participant's health, IIM symptoms, and take note of any unwanted effects. Participants fill in questionnaires about their IIM symptoms and how IIM impacts their quality of life. The results are compared between the 2 groups to see whether the treatment works.	Myopathies	Phase 3	Immunomodulation + Traitement symptomatique	United States, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, China, Czechia, France, Germany, Greece, Hungary, Italy, Japan, Mexico, Netherlands, Poland, Portugal, Romania, …	À vérifier
BIIL 284 BSTo evaluate the effect of multiple doses of BIIL 284 BS on the pharmacokinetics of a single dose of theophylline.	SEP	Phase 1	À vérifier		À vérifier
EmpagliflozinThe purpose of this study is to find out what effects (good and bad) the study medications (insulin or Empagliflozin) have on adults with mild memory impairment or early Alzheimer's disease who are clinically prescribed an anti-amyloid therapy compared to placebo.	Insuffisance cardiaque	Phase 2	À vérifier	Canada	À vérifier
VicadrostatThis study is open to adults with type 2 diabetes, high blood pressure, and cardiovascular disease. People can join the study if they have these conditions and do not have a history of heart failure. The purpose of this study is to find out if a medicine called vicadrostat, when taken with empagliflozin, helps reduce cardiovascular risk in people with these conditions. The study will compare this combination to a placebo version of vicadrostat with empagliflozin. Participants are put into 2 groups randomly, which means by chance. One group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets with empagliflozin. Placebo tablets look like vicadrostat tablets but do not contain any medicine. Participants take a tablet once per day for 2 and a half years and up to 4 years and 3 months. All participants also continue their medication for type 2 diabetes, high blood pressure, and cardiovascular disease. Participants have an equal chance of receiving the study medicine or placebo. Participants are in the study for up to 4 years and 3 months. During this time, they visit the study site regularly. During these visits, doctors collect information about participants' health and take blood samples. The doctors document when participants experience cardiovascular events. The doctors also regularly check participants' health and take note of any unwanted effects.	Insuffisance cardiaque	Phase 3	À vérifier	United States, Argentina, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czechia, Denmark, Germany, Hungary, India, Italy, Japan, Mexico, Netherlands, Poland, Romania, …	À vérifier
VicadrostatThis study is open to adults with type 2 diabetes, high blood pressure, and cardiovascular disease. People can join the study if they have these conditions and do not have a history of heart failure. The purpose of this study is to find out if a medicine called vicadrostat, when taken with empagliflozin, helps reduce cardiovascular risk in people with these conditions. The study will compare this combination to a placebo version of vicadrostat with empagliflozin. Participants are put into 2 groups randomly, which means by chance. One group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets with empagliflozin. Placebo tablets look like vicadrostat tablets but do not contain any medicine. Participants take a tablet once per day for 2 and a half years and up to 4 years and 3 months. All participants also continue their medication for type 2 diabetes, high blood pressure, and cardiovascular disease. Participants have an equal chance of receiving the study medicine or placebo. Participants are in the study for up to 4 years and 3 months. During this time, they visit the study site regularly. During these visits, doctors collect information about participants' health and take blood samples. The doctors document when participants experience cardiovascular events. The doctors also regularly check participants' health and take note of any unwanted effects.	Insuffisance cardiaque	Phase 3	À vérifier	United States, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czechia, Germany, Hungary, India, Italy, Japan, Mexico, Netherlands, Poland, Romania, …	À vérifier
EmpagliflozinThe purpose of this study is to find out what effects (good and bad) the study medications (insulin or Empagliflozin) have on adults with mild memory impairment or early Alzheimer's disease who are clinically prescribed an anti-amyloid therapy compared to placebo.	Maladie rénale chronique	Phase 3	À vérifier	United States, Argentina, Australia, Belgium, Canada, France, Germany, Hungary, Italy, Netherlands, Poland, Portugal, Singapore, South Korea, Spain, Sweden, Turkey (Türkiye), United Kingdom	À vérifier
BI 690517This study is open to adults with chronic kidney disease at risk of progression. People with and without type 2 diabetes can take part in this study. The study is open to people who take other medicines called angiotensin converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARB). People who already take empagliflozin or any other sodium-glucose cotransporter-2 inhibitor (SGLT2i) can also join. The study is also open to people who currently do not take any of these treatments. The purpose of this study is to find out whether a medicine called BI 690517 helps people with chronic kidney disease when taken in combination with a study medicine called empagliflozin. Worsening of kidney function increases the risk for kidney failure, cardiovascular disease, and heart failure hospitalisation. After a run-in period, during which participants are confirmed to be receiving clinically appropriate renin-angiotensin system blockade and are established on empagliflozin, they are randomly assigned (by chance) to 1 of 2 groups. One group receives BI 690517 tablets, and the other group receives placebo tablets. Placebo tablets look like BI 690517 but do not contain any medicine. Participants take 1 study tablet once a day, in addition to empagliflozin, for the duration of the study. The doctors document when participants experience worsening of their kidney disease, go to hospital due to heart failure, or die of cardiovascular problems during the study. The time to these events is compared between the 2 treatment groups to see whether the treatment works. The study continues until the required number of events have occurred which is about 3 to 4 years. During this time, participants visit the study site about 5 times within the first 6 months. Then they visit the study site every 6 months. At the visits, doctors regularly check participants' health, take blood and urine samples, measure blood pressure and weight, check kidney function, and take note of any unwanted effects.	Maladie rénale chronique	Phase 3	Ralentissement de la progression	United States, Argentina, Australia, Belgium, Brazil, Canada, China, Denmark, Germany, India, Italy, Japan, Malaysia, Mexico, New Zealand, Portugal, South Korea, Sweden, Taiwan, United Kingdom	À vérifier
SurvodutideThis study is for adults aged 18 years and older who have a type of fatty liver disease called metabolic dysfunction-associated steatotic liver disease (MASLD). People can take part if their body mass index (BMI) is 27 kg/m² or higher, and they have certain heart and blood vessel risk factors. The purpose of this study is to find out how a medicine called survodutide affects heart structure and function in people with MASLD. Participants are put into 2 groups randomly, which means by chance. One group gets survodutide as an injection under the skin of the abdomen once a week. The other group gets placebo as an injection once a week. Placebo looks like survodutide but does not contain any medicine. The first injection is given at the study site. Later injections are usually given by the participants themselves at home using pre-filled syringes. Participants and doctors do not know who is getting survodutide or placebo. Participants are in the study for up to 1.5 years. During this time, they visit the study site about 14 times and have about 4 phone calls with the study staff. At some of the visits, doctors use ultrasound scans to check the heart. The results are compared between the 2 groups to see if survodutide helps improve the health of the heart. The study staff also regularly check participants' health and take note of any health problems.	Maladie coronarienne	Phase 3	À vérifier	United States, China, Germany, Spain, United Kingdom	À vérifier
EmpagliflozinThe purpose of this study is to find out what effects (good and bad) the study medications (insulin or Empagliflozin) have on adults with mild memory impairment or early Alzheimer's disease who are clinically prescribed an anti-amyloid therapy compared to placebo.	Maladie rénale chronique	Phase 1	À vérifier	United States	À vérifier
SurvodutideThis study is for adults aged 18 years and older who have a type of fatty liver disease called metabolic dysfunction-associated steatotic liver disease (MASLD). People can take part if their body mass index (BMI) is 27 kg/m² or higher, and they have certain heart and blood vessel risk factors. The purpose of this study is to find out how a medicine called survodutide affects heart structure and function in people with MASLD. Participants are put into 2 groups randomly, which means by chance. One group gets survodutide as an injection under the skin of the abdomen once a week. The other group gets placebo as an injection once a week. Placebo looks like survodutide but does not contain any medicine. The first injection is given at the study site. Later injections are usually given by the participants themselves at home using pre-filled syringes. Participants and doctors do not know who is getting survodutide or placebo. Participants are in the study for up to 1.5 years. During this time, they visit the study site about 14 times and have about 4 phone calls with the study staff. At some of the visits, doctors use ultrasound scans to check the heart. The results are compared between the 2 groups to see if survodutide helps improve the health of the heart. The study staff also regularly check participants' health and take note of any health problems.	Maladie rénale chronique	Phase 3	À vérifier	United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Czechia, Denmark, Finland, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Japan, …	À vérifier
EmpagliflozinThe purpose of this study is to find out what effects (good and bad) the study medications (insulin or Empagliflozin) have on adults with mild memory impairment or early Alzheimer's disease who are clinically prescribed an anti-amyloid therapy compared to placebo.	Maladie rénale chronique	À vérifier	À vérifier	Spain	À vérifier

Essais cliniques

Molécule	Indication / population	Phase	NCT	Titre	Statut
Empagliflozin	Maladie rénale chronique	À vérifier	NCT07348484	Urinary Biomarker-Based Diagnostic and Monitoring System for Chronic Kidney Disease and Real-World Effectiveness of SGLT2 Inhibitors	RECRUITING
Survodutide	Maladie rénale chronique	Phase 3	NCT06077864	A Study to Test the Effect of Survodutide (BI 456906) on Cardiovascular Safety in People With Overweight or Obesity (SYNCHRONIZE™ - CVOT)	COMPLETED
Empagliflozin	Maladie rénale chronique	Phase 1	NCT05614115	Safety, Tolerability, and Feasibility of Empagliflozin Therapy in Dialysis-dependent ESKD	COMPLETED
Survodutide	Maladie coronarienne	Phase 3	NCT07850063	ELEVATE-LIVER: A Study to Test Whether Survodutide Helps Improve Heart Structure and Function in People With Overweight or Obesity and Fatty Liver Disease	NOT_YET_RECRUITING
BI 690517	Maladie rénale chronique	Phase 3	NCT06531824	EASi-KIDNEY™ (The Studies of Heart & Kidney Protection With BI 690517 in Combination With Empagliflozin)	ACTIVE_NOT_RECRUITING
Empagliflozin	Maladie rénale chronique	Phase 3	NCT07107945	A Study to Find Out How EMPAgliflozin is Tolerated and if it Helps Children and Adolescents With Chronic KIDNEY Disease (EMPA-KIDNEY® Kids)	ACTIVE_NOT_RECRUITING
Tenecteplase	Accident vasculaire cérébral	Phase 3	NCT07361302	TENACITY — A Study to Test if Tenecteplase Helps People to Recover From an Acute Stroke When Given More Than 4.5 Hours After the Person Was Last Seen Well	RECRUITING
Vicadrostat	Insuffisance cardiaque	Phase 3	NCT06424288	A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Heart Failure	RECRUITING
Vicadrostat	Insuffisance cardiaque	Phase 3	NCT06935370	A Study to Test Whether Vicadrostat (BI 690517) in Combination With Empagliflozin Helps People With Heart Failure and a Weak Pumping Function of the Left Side of the Heart	RECRUITING
Empagliflozin	Insuffisance cardiaque	Phase 2	NCT06570473	CRAVE — Feasibility Trial for a Right Ventricular Failure Platform Trial	RECRUITING
BIIL 284 BS	SEP	Phase 1	NCT02273440	Effect of BIIL 284 BS on the Pharmacokinetics of Theophylline in Healthy Male Volunteers	COMPLETED
Nerandomilast	Myopathies	Phase 3	NCT07789015	VERANDA™-IIM — A Study to Understand How Nerandomilast Works in People With Active Idiopathic Inflammatory Myopathies	NOT_YET_RECRUITING
Vicadrostat	Hypertension	Phase 3	NCT07064473	EASi-PROTKT™ - A Study to Test Vicadrostat (BI 690517) Taken Together With Empagliflozin in People With Type 2 Diabetes, High Blood Pressure, and Cardiovascular Disease	RECRUITING
BI 3000202	Lupus	Phase 2	NCT07409181	A Study to Test Whether Different Doses of BI 3000202 Help People With Systemic Lupus Erythematosus (SLE)	RECRUITING
Empagliflozin	Alzheimer	Phase 2	NCT07756294	REVITAA-ALZ — Restoring Vascular and Insulin Function To Augment Anti-Amyloid Therapy in Alzheimer's Disease	NOT_YET_RECRUITING
Telmisartan	Hypertension	Phase 3	NCT00274118	DETAIL Study: Diabetes Exposed to Telmisartan and Enalapril	COMPLETED

Publications

Molécule	Indication / population	Titre	Journal	Date
Aucune publication.