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Survodutide clinical trials

ClinicalTrials.gov lists 35 registered trials of Survodutide: 8 recruiting or about to, 2 running, 25 completed, 12 in phase 3, 3 with results posted. Recruiting sites are in United States, Germany, China, Spain, United Kingdom, Australia. The largest is A Study to Test the Effect of Survodutide (BI 456906) on Cardiovascular Safety in People With Overweight or Obesity (SYNCHRONIZE™ - CVOT) (5,531 people).

35registered trials

8recruiting now

2running

25completed

12in phase 3

3with results posted

Recruiting: 8Running: 2Completed: 2535trials
  • Recruiting 8
  • Running 2
  • Completed 25

Where Survodutide is in testing

Registered trials by phase. Phase 3 trials are the large ones that decide approval.

0Early phase 1First doses in people
19Phase 1Safety and dosing
4Phase 2Does it work?
12Phase 3Large confirmatory trials
0Phase 4After approval
0Not phasedObservational and other

Timeline

Each bar runs from a trial's start to its planned end; faded bars have no end date. Click a bar to open the trial.

20182020202220242026202820302032SYNCHRONIZE®-START- A Study to Test Whether Survodutide Helps People Living With Overweight or Obesity Who do Not Have Diabetes to Lose Weight · Recruiting · Phase 3 · 350 people · 2026-11-07 to 2028-06-25SYNCHRONIZE®-HERA: A Study to Test Whether Survodutide Helps Women Who Are Living With Overweight or Obesity and Are Going Through or Have Finished Menopause, to Lose Weight · Recruiting · Phase 3 · 600 people · 2026-10-31 to 2028-07-26ELEVATE-LIVER: A Study to Test Whether Survodutide Helps Improve Heart Structure and Function in People With Overweight or Obesity and Fatty Liver Disease · Recruiting · Phase 3 · 600 people · 2026-10-23 to 2029-04-29A Study to Compare How 2 Different Formulations of Survodutide Are Taken up in the Body When Given by Injection in Healthy Men and Women With and Without Overweight or Obesity · Recruiting · Phase 1 · 44 people · 2026-09-02 to 2026-12-08A Study to Test Whether Survodutide Helps People With Type 2 Diabetes Control Their Blood Sugar · Recruiting · Phase 3 · 600 people · 2026-08-24 to 2028-01-17A Study in Healthy People or Otherwise Healthy With Overweight or Obesity to Compare 2 Formulations of Survodutide Given in Different Ways, Either as a Pre-filled Syringe or a Pen-like Injector · Completed · Phase 1 · 56 people · 2026-03-03 to 2026-05-28Albuminuria Reduction Study With Survodutide Treatment in Kidney Disease · Recruiting · Phase 2 · 120 people · 2026-03-02 to 2027-11-30A Study in Healthy People to Compare How 2 Different Formulations of Survodutide Are Taken up by the Body · Completed · Phase 1 · 100 people · 2025-11-05 to 2026-07-28A Study in Healthy People to Compare How 2 Different Formulations of Survodutide Are Taken up in the Body · Completed · Phase 1 · 16 people · 2025-07-28 to 2025-10-07A Study to Test Whether Survodutide Improves How the Body Uses Energy and Breaks Down Fat in People With Obesity · Running · Phase 1 · 64 people · 2025-03-26 to 2027-01-08A Study in Healthy People to Compare How 3 Different Formulations of Survodutide Are Taken up in the Body · Completed · Phase 1 · 30 people · 2025-02-10 to 2025-05-29LIVERAGE™ - Cirrhosis: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Cirrhosis · Recruiting · Phase 3 · 1,590 people · 2024-11-12 to 2029-06-05A Study in People With Obesity to Test the Effects of BI 456906 Compared With Semaglutide on Glucagon Receptor Activity in the Liver · Running · Phase 1 · 29 people · 2024-11-01 to 2027-01-06LIVERAGE™: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Moderate or Advanced Liver Fibrosis · Recruiting · Phase 3 · 1,800 people · 2024-10-14 to 2031-12-27A Study to Test Whether BI 456906 (Survodutide) Influences the Amount of Bupropion, Caffeine and Midazolam in the Blood in People With Overweight or Obesity · Completed · Phase 1 · 34 people · 2024-10-01 to 2025-12-16A Study in Chinese People With Overweight or Obesity to Test How Different Doses of Survodutide Are Taken up in the Body · Completed · Phase 1 · 30 people · 2024-08-12 to 2025-04-15A Study to Test How BI 456906 is Taken up in the Blood of People With and Without Kidney Problems · Completed · Phase 1 · 42 people · 2024-05-15 to 2025-09-16A Study in People With Overweight or Obesity to Test How BI 1820237, BI 456906, or a Combination of Both Affects Brain Activity · Completed · Phase 1 · 23 people · 2024-04-30 to 2025-02-24A Study to Test Whether Survodutide Helps People Living With Obesity or Overweight and With a Confirmed or Presumed Liver Disease Called Non-alcoholic Steatohepatitis (NASH) to Reduce Liver Fat and to Lose Weight (SYNCHRONIZE-MASLD) · Completed · Phase 3 · 218 people · 2024-04-02 to 2025-10-09A Study to Test Whether Multiple Doses of BI 456906 Have an Effect on Cardiac Safety in People With Overweight or Obesity · Completed · Phase 1 · 110 people · 2024-03-13 to 2025-10-22A Study to Test Whether Survodutide (BI 456906) Helps Chinese People Living With Overweight or Obesity to Lose Weight · Completed · Phase 3 · 307 people · 2024-02-06 to 2025-07-29A Study to Test Whether Survodutide Helps Japanese People Living With Obesity Disease · Completed · Phase 3 · 274 people · 2024-01-16 to 2025-12-03A Study in Women With Overweight or Obesity to Test Whether Different Doses of BI 456906 Influence the Amount of a Contraceptive in the Blood · Completed · Phase 1 · 32 people · 2023-12-21 to 2025-02-14A Study to Test Whether Survodutide (BI 456906) Helps People Living With Overweight or Obesity Who Also Have Diabetes to Lose Weight · Completed · Phase 3 · 755 people · 2023-11-27 to 2025-12-12A Study to Test Whether Survodutide (BI 456906) Helps People Living With Overweight or Obesity Who do Not Have Diabetes to Lose Weight · Completed · Phase 3 · 726 people · 2023-11-25 to 2025-12-02A Study to Test the Effect of Survodutide (BI 456906) on Cardiovascular Safety in People With Overweight or Obesity (SYNCHRONIZE™ - CVOT) · Completed · Phase 3 · 5,531 people · 2023-11-20 to 2026-06-01A Study in People With Overweight or Obesity to Test How Well Different Doses of BI 1820237 Are Tolerated When Given Alone or in Combination With Either Semaglutide or BI 456906 · Completed · Phase 1 · 88 people · 2023-04-11 to 2024-08-01A Study in Healthy Men to Test How BI 456906 is Processed in the Body · Completed · Phase 1 · 6 people · 2022-07-04 to 2022-11-17A Study to (1) Compare How BI 456906 is Taken up in the Body of Healthy People and People With Liver Problems and (2) Find Out How People With Overweight and Obesity, With and Without Liver Problems, Tolerate Different Doses of BI 456906 · Completed · Phase 1 · 82 people · 2022-04-27 to 2023-12-29A Study to Test Safety and Efficacy of Survodutide (BI456906) in Adults With Non-alcoholic Steatohepatitis (NASH) and Fibrosis (F1-F3) · Completed · Phase 2 · 295 people · 2021-04-27 to 2023-11-09A Study to Test Whether Different Doses of BI 456906 Help People With Overweight or Obesity to Lose Weight · Completed · Phase 2 · 387 people · 2021-03-08 to 2022-09-15A Study to Test How Different Doses of BI 456906 Are Tolerated in Japanese Men With a Body Mass Index (BMI) Between 23 and 40 kg/m2 · Completed · Phase 1 · 37 people · 2020-06-01 to 2020-11-17A Study to Test Whether Different Doses of BI 456906 Are Effective in Treating Adults With Type 2 Diabetes. · Completed · Phase 2 · 413 people · 2020-04-30 to 2021-10-08A Study to Test Different Doses of BI 456906 in Patients With Obesity · Completed · Phase 1 · 131 people · 2018-07-26 to 2020-04-20Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 456906 in Healthy Male Volunteers · Completed · Phase 1 · 20 people · 2017-06-30 to 2018-02-19
RecruitingRunningCompletedStopped or withdrawnStatus unknownToday

Where trials are recruiting

Countries with sites in trials that are recruiting now.

26 more countries.

Recruiting now 8

SYNCHRONIZE®-START- A Study to Test Whether Survodutide Helps People Living With Overweight or Obesity Who do Not Have Diabetes to Lose Weight

Not yet recruitingPhase 3350 peopleBoehringer Ingelheim2026-11-07 → 2028-06-25🇺🇸 United States

Studying: Obesity · NCT07855900

About this trial

This study is open to adults with overweight or obesity. People can join the study if they have a body mass index (BMI) of 30 kg/m² or more, or a BMI of 27 kg/m² or more with at least one weight- related health problem. Participants must not have diabetes, and they must have tried to lose weight by dieting at least once in the past without success. The purpose of this study is to find out whether a medicine called survodutide helps people with overweight or obesity lose weight. This study has 2 groups. The groups differ based on their starting dose and whether they have used similar weight-lo…

SYNCHRONIZE®-HERA: A Study to Test Whether Survodutide Helps Women Who Are Living With Overweight or Obesity and Are Going Through or Have Finished Menopause, to Lose Weight

Not yet recruitingPhase 3600 peopleRandomizedBoehringer Ingelheim2026-10-31 → 2028-07-26🇺🇸 United States

Studying: Obesity · NCT07850050

About this trial

This study is open to women up to 65 years of age who are living with overweight or obesity and are going through or have finished menopause. People can join this study if they have a Body Mass Index (BMI) of 30 kg/m² or more, or if their BMI is 27 kg/m² or more and they have one or more weight related health problems. Participants must also have tried to lose weight by dieting at least once in the past without success. People with pre-existing diabetes cannot take part in this study. The purpose of this study is to find out whether a medicine called survodutide helps women with overweight or …

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 recruitingPhase 3600 peopleRandomizedBoehringer Ingelheim2026-10-23 → 2029-04-29🇨🇳🇩🇪🇪🇸🇬🇧 China, Germany, Spain, United Kingdom +1 more

Studying: Obesity, Metabolic Dysfunction-associated Steatotic Liver Disease · NCT07850063

About this trial

This 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 …

A Study to Compare How 2 Different Formulations of Survodutide Are Taken up in the Body When Given by Injection in Healthy Men and Women With and Without Overweight or Obesity

RecruitingPhase 144 peopleRandomizedBoehringer Ingelheim2026-09-02 → 2026-12-08🇩🇪 Germany

Studying: Healthy, Obesity · NCT07768813

About this trial

The main objective of this trial is to establish the bioequivalence of survodutide in a pre-filled syringe (reference product \[formulation A\]) and in a vial (test product \[formulation B2\]) in male and female trial participants who are healthy or otherwise healthy with overweight/obesity, following subcutaneous administration.

A Study to Test Whether Survodutide Helps People With Type 2 Diabetes Control Their Blood Sugar

RecruitingPhase 3600 peopleRandomizedBoehringer Ingelheim2026-08-24 → 2028-01-17🇦🇺🇨🇦🇮🇳🇳🇿 Australia, Canada, India, New Zealand +2 more

Studying: Type 2 Diabetes · NCT07754461

About this trial

This study aims to find out whether a study medicine called survodutide helps people control their blood sugar. Adults who live with type 2 diabetes and with a body mass index (BMI) of 23 kg/m2 or higher can join. The study has 3 parts. In each part the study compares survodutide with placebo. Survodutide is being developed to treat several health problems including type 2 diabetes. Placebo looks like survodutide but does not contain any medicine. Depending on a person's diabetes treatment, a person will be assigned either to * Part A: healthy eating and physical activity * Part B: diabetes…

Albuminuria Reduction Study With Survodutide Treatment in Kidney Disease

Not yet recruitingPhase 2120 peopleRandomizedUniversity Medical Center Groningen2026-03-02 → 2027-11-30

Studying: Chronic Kidney Disease · NCT07206290

About this trial

The ARTIST-CKD trial is a clinical study evaluating the effect of weekly subcutaneous administration of survodutide (3.6 mg) on kidney function in patients with chronic kidney disease (CKD) and elevated albuminuria. The primary objective is to determine whether survodutide leads to early, sustained, and clinically meaningful reductions in albuminuria, regardless of diabetes status.

LIVERAGE™ - Cirrhosis: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Cirrhosis

RecruitingPhase 31,590 peopleRandomizedBoehringer Ingelheim2024-11-12 → 2029-06-05🇦🇷🇦🇺🇦🇹🇧🇪 Argentina, Australia, Austria, Belgium +32 more

Studying: Metabolic Dysfunction Associated Steatohepatitis · NCT06632457

About this trial

This study is open to adults who are at least 18 years old and have: * A confirmed liver disease called non-alcoholic steatohepatitis (NASH) or * A confirmed liver disease called metabolic-associated steatohepatitis (MASH) * BMI of 27 kg/m2 or more or * 25 kg/m2 or more if the participant is Asian. People with a history of other chronic liver diseases or high alcohol intake cannot take part in this study. The purpose of this study is to find out whether a medicine called survodutide helps people with NASH or MASH improve their liver function. Participants are put into 2 groups randomly, whi…

LIVERAGE™: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Moderate or Advanced Liver Fibrosis

RecruitingPhase 31,800 peopleRandomizedBoehringer Ingelheim2024-10-14 → 2031-12-27🇦🇷🇦🇺🇦🇹🇧🇪 Argentina, Australia, Austria, Belgium +32 more

Studying: Metabolic Dysfunction Associated Steatohepatitis (MASH), Liver Fibrosis · NCT06632444

About this trial

This study is open to adults who are at least 18 years old living with obesity and have: * a confirmed liver disease called non-alcoholic steatohepatitis (NASH)/metabolic associated steatohepatitis (MASH) and * moderate or advanced liver fibrosis People with a history of acute or chronic liver diseases other than MASH or chronic alcohol intake cannot take part in this study. The purpose of this study is to find out whether a medicine called survodutide helps people with MASH and moderate or advanced liver fibrosis improve their liver function. This study has 2 parts. The purpose of the firs…

Active, not recruiting 2

A Study to Test Whether Survodutide Improves How the Body Uses Energy and Breaks Down Fat in People With Obesity

Active, not recruitingPhase 164 peopleRandomizedBoehringer Ingelheim2025-03-26 → 2027-01-08🇺🇸 United States

Studying: Obesity · NCT06745284

About this trial

This study is open to adults between 18 and 65 years of age who have obesity. People can join the study if they have a body mass index (BMI) between 30 and 45 km/m². The purpose of this study is to find out whether a medicine called survodutide improves how the body uses energy and breaks down fat. This study compares survodutide with another medicine called semaglutide. Survodutide is being developed to treat people with obesity. Semaglutide is already used to treat people with obesity. Participants are put into 2 groups by chance. One group gets survodutide and the other group gets semaglu…

A Study in People With Obesity to Test the Effects of BI 456906 Compared With Semaglutide on Glucagon Receptor Activity in the Liver

Active, not recruitingPhase 129 peopleRandomizedBoehringer Ingelheim2024-11-01 → 2027-01-06🇳🇱 Netherlands

Studying: Obesity · NCT05202353

About this trial

This study is open to adults with obesity. People with a body mass index (BMI) in the range from 30 to 40 kg/m2 and a body weight of 70 to 150 kg can participate in the study. The purpose of this study is to find out whether treatment with a medicine called BI 456906 changes the occupancy of receptors in the liver and in the pancreas. These receptors are involved in appetite and weight regulation. To measure the occupancy of these receptors, doctors use injectable tracers. Doctors visualise the binding of the tracers to these receptors with imaging methods. Participants are put into 4 groups …

Completed 25

A Study to Test Whether Different Doses of BI 456906 Are Effective in Treating Adults With Type 2 Diabetes.

CompletedPhase 2413 peopleRandomizedBoehringer Ingelheim2020-04-30 → 2021-10-08🇦🇺🇦🇹🇨🇦🇨🇿 Australia, Austria, Canada, Czechia +10 moreResults posted

Studying: Diabetes Mellitus, Type 2 · NCT04153929

About this trial

This study is open to adults with type 2 diabetes who take metformin but still have too high blood sugar. The purpose of the study is to find the best dose of BI 456906 that reduces blood sugar. The study also looks at whether BI 456906 helps the participants lose weight. Participants are in the study for about 23 weeks. During this time, most participants visit the study site about 13 times. Some participants visit the study site about 20 times. At the start of the study, the participants are put into 7 groups. The participants in groups 1 to 6 get injections under the skin once or twice eve…

A Study to Test Whether Different Doses of BI 456906 Help People With Overweight or Obesity to Lose Weight

CompletedPhase 2387 peopleRandomizedBoehringer Ingelheim2021-03-08 → 2022-09-15🇦🇺🇧🇪🇨🇦🇨🇳 Australia, Belgium, Canada, China +8 moreResults posted

Studying: Obesity · NCT04667377

About this trial

This study is open to adults, aged 18 to 75 years, with overweight or obesity. People with body mass index (BMI) of 27 or higher to join the study. People who have diabetes cannot participate. The purpose of this study is to find out whether a medicine called BI 456906 helps people lose weight. Participants are put into 5 groups by chance. 4 groups get different doses of BI 456906. The fifth group gets placebo. Participants get BI 456906 or placebo as injections under the skin once a week. Placebo injections look like BI 456906 injections but do not contain any medicine. Participants are in …

A Study to Test Safety and Efficacy of Survodutide (BI456906) in Adults With Non-alcoholic Steatohepatitis (NASH) and Fibrosis (F1-F3)

CompletedPhase 2295 peopleRandomizedBoehringer Ingelheim2021-04-27 → 2023-11-09🇦🇺🇦🇹🇧🇪🇨🇦 Australia, Austria, Belgium, Canada +21 moreResults posted

Studying: Non-alcoholic Steatohepatitis (NASH) · NCT04771273

About this trial

This study is open for men and women with a liver disease called nonalcoholic steatohepatitis (NASH) and liver fibrosis. The purpose of the study is to find out whether a medicine called BI 456906 helps patients with NASH and liver fibrosis. The study tests 3 different doses of BI 456906 to find the dose that helps best. Participants are put into 4 groups randomly, which means by chance. There are 3 groups that each receive a different dose of BI 456906 and there is 1 group that receives placebo. BI 456906 and placebo are given as an injection under the skin once per week. The placebo injectio…

A Study to Test the Effect of Survodutide (BI 456906) on Cardiovascular Safety in People With Overweight or Obesity (SYNCHRONIZE™ - CVOT)

CompletedPhase 35,531 peopleRandomizedBoehringer Ingelheim2023-11-20 → 2026-06-01🇦🇷🇦🇺🇦🇹🇧🇪 Argentina, Australia, Austria, Belgium +31 more

Studying: Obesity · NCT06077864

About this trial

This study is open to adults who are at least 18 years old and have a body mass index (BMI) of 27 kg/m2 or more. People can take part if they have cardiovascular or chronic kidney disease. People who have at least 2 health problems related to their weight or risks of cardiovascular disease can participate. Participants must have previously tried to lose weight by changing their diet. The purpose of this study is to find out whether people with overweight or obesity who take a medicine called survodutide (BI 456906) are less or more likely to develop serious cardiovascular problems. It also ai…

A Study to Test Whether Survodutide (BI 456906) Helps People Living With Overweight or Obesity Who Also Have Diabetes to Lose Weight

CompletedPhase 3755 peopleRandomizedBoehringer Ingelheim2023-11-27 → 2025-12-12🇦🇺🇧🇪🇨🇦🇨🇳 Australia, Belgium, Canada, China +15 more

Studying: Obesity, Diabetes Mellitus, Type 2 · NCT06066528

About this trial

This study is open to adults who are at least 18 years old and have a body mass index of 27 kg/m² or more. People can take part if they have type 2 diabetes and if they are currently being treated only with diet and exercise or with specific diabetes medications. Only people who have previously not managed to lose weight by changing their diet can participate. The purpose of this study is to find out whether a medicine called survodutide (BI 456906) helps people living with overweight or obesity who also have diabetes to lose weight. Participants are divided into 3 groups by chance, like dra…

A Study to Test Whether Survodutide (BI 456906) Helps People Living With Overweight or Obesity Who do Not Have Diabetes to Lose Weight

CompletedPhase 3726 peopleRandomizedBoehringer Ingelheim2023-11-25 → 2025-12-02🇦🇺🇧🇪🇨🇦🇨🇳 Australia, Belgium, Canada, China +10 more

Studying: Obesity · NCT06066515

About this trial

This study is open to adults who are at least 18 years old and have * a body mass index (BMI) of 30 kg/m² or more, or * a BMI of 27 kg/m² or more and at least one health problem related to their weight. People with type 2 diabetes cannot take part in this study. Only people who have previously not managed to lose weight by changing their diet can participate. The purpose of this study is to find out whether a medicine called survodutide (BI 456906) helps people living with overweight or obesity to lose weight. Participants are divided into 3 groups by chance, like drawing names from a hat. …

A Study to Test Whether Survodutide (BI 456906) Helps Chinese People Living With Overweight or Obesity to Lose Weight

CompletedPhase 3307 peopleRandomizedBoehringer Ingelheim2024-02-06 → 2025-07-29🇨🇳 China

Studying: Obesity, Overweight · NCT06214741

About this trial

This study in China is open to adults who are at least 18 years old who are living with overweight or obesity. People with a body mass index (BMI) of 28 kg/m\^2 or higher or 24 kg/m\^2 or higher with at least 1 weight related problem can join the study. The main purpose of this study is to find out whether a medicine called survodutide helps people with overweight or obesity. 2 different doses of survodutide are tested in this study. Participants are put into 3 groups by chance. Each participant has an equal chance of being in each group. 2 groups get different doses of survodutide. 1 group g…

A Study to Test Whether Survodutide Helps Japanese People Living With Obesity Disease

CompletedPhase 3274 peopleRandomizedBoehringer Ingelheim2024-01-16 → 2025-12-03🇯🇵 Japan

Studying: Obesity · NCT06176365

About this trial

This study is open to adults who are at least 18 years old and have * a body mass index (BMI) of 35 kg/m² or more and at least one health problem related to their weight, or * a BMI of 27 kg/m² or more and at least two health problems related to their weight. People who have either type 2 diabetes, high blood pressure, or increased blood lipids can take part in this study. Only people who have previously not managed to lose weight by changing their diet can participate. The purpose of this study is to find out whether a medicine called survodutide (BI 456906) helps people living with obesit…

A Study to Test Whether Survodutide Helps People Living With Obesity or Overweight and With a Confirmed or Presumed Liver Disease Called Non-alcoholic Steatohepatitis (NASH) to Reduce Liver Fat and to Lose Weight (SYNCHRONIZE-MASLD)

CompletedPhase 3218 peopleRandomizedBoehringer Ingelheim2024-04-02 → 2025-10-09🇪🇸🇺🇸 Spain, United States

Studying: Obesity, Non-Alcoholic SteatoHepatitis (NASH) · NCT06309992

About this trial

This study is open to adults who are at least 18 years old and have * presumed or confirmed NASH together with overweight or obesity and * a body mass index (BMI) of 30 kg/m² or more, or * a BMI of 27 kg/m² and at least one weight-related health problem. People with a history of other chronic liver diseases cannot take part in this study. The purpose of this study is to find out whether a medicine called survodutide helps people living with obesity or overweight and a confirmed or presumed liver disease called nonalcoholic steatohepatitis (NASH) to have less liver fat and to lose weight. Pa…

A Study to Test Different Doses of BI 456906 in Patients With Obesity

CompletedPhase 1131 peopleRandomizedBoehringer Ingelheim2018-07-26 → 2020-04-20🇩🇪 Germany

Studying: Obesity · NCT03591718

About this trial

Main objective is to investigate the tolerability of different titration schemes of BI 456906 in otherwise healthy patients with obesity/overweight, and to determine a titration scheme for future studies.

A Study to Test Whether Multiple Doses of BI 456906 Have an Effect on Cardiac Safety in People With Overweight or Obesity

CompletedPhase 1110 peopleRandomizedBoehringer Ingelheim2024-03-13 → 2025-10-22🇩🇪 Germany

Studying: Overweight, Obesity · NCT06200467

About this trial

This study is open to adults between 18 and 55 years of age with overweight or obesity. The purpose of this study is to find out whether a medicine called survodutide (BI 456906) has an effect on cardiac safety. When a new medicine is developed, it is important to check whether it affects the heart. Moxifloxacin is a medicine that is known to change the heart rhythm. In this study, moxifloxacin is used as a so-called positive control. Participants are put into 3 groups by chance. There is a different treatment schedule for each of the groups. All participants start with one placebo injection …

A Study in Healthy People to Compare How 2 Different Formulations of Survodutide Are Taken up by the Body

CompletedPhase 1100 peopleRandomizedBoehringer Ingelheim2025-11-05 → 2026-07-28🇩🇪 Germany

Studying: Healthy · NCT07221591

About this trial

This study is open to healthy people between 18 and 65 years of age. People can join the study if they have a body mass index between 27 and 39.9 kg/m2. The purpose of this study is to test a new formulation of a medicine called survodutide. Survodutide is being developed to help people with obesity and people with liver conditions. When a new formulation is developed, it is important to understand how it is taken up by the body. Participants are divided into 2 groups by chance. One group gets the reference formulation of survodutide (formulation A). The other group gets the new formulation …

A Study in People With Overweight or Obesity to Test How Well Different Doses of BI 1820237 Are Tolerated When Given Alone or in Combination With Either Semaglutide or BI 456906

CompletedPhase 188 peopleRandomizedBoehringer Ingelheim2023-04-11 → 2024-08-01🇩🇪 Germany

Studying: Healthy, Obesity · NCT05751226

About this trial

This study is open to adults between 18 and 55 years of age who are living with overweight or obesity. People with a body mass index (BMI) from 27 to 40 kg/m2 can join the study. The main purpose of this study is to find out how a medicine called BI 1820237 is tolerated by people with overweight or obesity when taken alone or in combination with a medicine called semaglutide or with a medicine called BI 456906. Participants are divided into different groups. All participants in the study either take different doses of BI 1820237 or placebo. Some of the groups take either semaglutide or BI 45…

A Study to (1) Compare How BI 456906 is Taken up in the Body of Healthy People and People With Liver Problems and (2) Find Out How People With Overweight and Obesity, With and Without Liver Problems, Tolerate Different Doses of BI 456906

CompletedPhase 182 peopleBoehringer Ingelheim2022-04-27 → 2023-12-29🇩🇪🇭🇺🇳🇿🇵🇱 Germany, Hungary, New Zealand, Poland +2 more

Studying: Healthy, Liver Diseases, Obesity · NCT05296733

About this trial

This study is open to adults who have different levels of liver problems and adults who are healthy. People with or without overweight or obesity can take part. This study has 2 parts. The purpose of Part 1 is to find out whether having liver problems influences how BI 456906 is taken up in the body. The purpose of Part 2 is to find out whether having liver problems influences how people with overweight and obesity tolerate different doses of BI 456906. In Part 1, participants get a single injection of BI 456906 under their skin and stay at the study site for 2 nights afterwards. They are in…

A Study in Healthy People or Otherwise Healthy With Overweight or Obesity to Compare 2 Formulations of Survodutide Given in Different Ways, Either as a Pre-filled Syringe or a Pen-like Injector

CompletedPhase 156 peopleRandomizedBoehringer Ingelheim2026-03-03 → 2026-05-28🇩🇪 Germany

Studying: Healthy, Obesity · NCT07413913

About this trial

The goal of this study is to find out whether different formulations of survodutide given by different delivery methods is taken up in the body in a similar way. Participants visit the study site regularly. During study visits, the doctors collect information about participants' health. To assess the study endpoints, participants regularly have blood samples taken.

A Study to Test How BI 456906 is Taken up in the Blood of People With and Without Kidney Problems

CompletedPhase 142 peopleBoehringer Ingelheim2024-05-15 → 2025-09-16🇩🇪 Germany

Studying: Healthy, Renal Impairment · NCT06352411

About this trial

This study is open to adults aged between 18 and 80 years of age with a body mass index (BMI) of 20 to 40 kg/m2. People with or without kidney problems can take part in the study. The purpose of this study is to find out how much of a medicine called BI 456906 gets into the blood of people with and without kidney problems. BI 456906 is being developed to treat people with obesity and liver problems. People living with these conditions often also have kidney problems. Therefore, it is important to find out whether kidney problems influence the amount of BI 456906 that gets into the blood. Stu…

A Study to Test How Different Doses of BI 456906 Are Tolerated in Japanese Men With a Body Mass Index (BMI) Between 23 and 40 kg/m2

CompletedPhase 137 peopleRandomizedBoehringer Ingelheim2020-06-01 → 2020-11-17🇯🇵 Japan

Studying: Healthy · NCT04384081

About this trial

Main objectives are to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of different dose escalation schemes of BI 456906 in healthy Japanese male subject with BMI 23-40 kg/m2 and to determine a dose escalation scheme for future studies.

A Study to Test Whether BI 456906 (Survodutide) Influences the Amount of Bupropion, Caffeine and Midazolam in the Blood in People With Overweight or Obesity

CompletedPhase 134 peopleBoehringer Ingelheim2024-10-01 → 2025-12-16🇧🇪 Belgium

Studying: Overweight, Obesity · NCT06564441

About this trial

This study is open to adults with overweight or obesity who are otherwise healthy. People can join the study if they have a body mass index of 27 to 39.9 kg/m2 and a body weight over 70 kg. The purpose of this study is to find out whether taking multiple doses of BI 456906 influences the amount of bupropion, caffeine, and midazolam in the blood. The study has 2 treatment periods. In Period 1, participants take 1 dose each of midazolam, caffeine, and bupropion as tablets or oral solution on separate days. In Period 2, participants get BI 456906 as an injection under the skin once a week. At 2 …

A Study in Women With Overweight or Obesity to Test Whether Different Doses of BI 456906 Influence the Amount of a Contraceptive in the Blood

CompletedPhase 132 peopleBoehringer Ingelheim2023-12-21 → 2025-02-14🇩🇪 Germany

Studying: Healthy · NCT05896384

About this trial

This study is open to women with overweight or obesity who are otherwise healthy. Women with a body mass index (BMI) from 27 to 40 kg/m2 can participate. The purpose of this study is to find out whether taking multiple doses of BI 456906 influences the amount of ethinylestradiol and levonorgestrel in the blood. Ethinylestradiol and levonorgestrel are ingredients of the contraceptive Microgynon®. The study has 2 treatment periods. In Period 1, participants get 1 tablet of Microgynon®. In Period 2, participants get weekly injections of BI 456906 for 7 months. The doses of BI 456906 increase eac…

A Study in Chinese People With Overweight or Obesity to Test How Different Doses of Survodutide Are Taken up in the Body

CompletedPhase 130 peopleBoehringer Ingelheim2024-08-12 → 2025-04-15🇨🇳 China

Studying: Overweight, Obesity · NCT06492135

About this trial

This study is open to Chinese adults aged 18 to 60 with overweight or obesity. People can join the study if they have a Body Mass Index from 24 to 40.0 kg/m2. Survodutide is a medicine being developed to help people with overweight or obesity. The purpose of this study is to find out how different doses of survodutide are taken up in the body. Other goals are to test if participants can tolerate different doses of survodutide and whether survodutide helps people with overweight or obesity. Participants receive survodutide as an injection under the skin once a week for 7.5 months. During this…

Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 456906 in Healthy Male Volunteers

CompletedPhase 120 peopleRandomizedBoehringer Ingelheim2017-06-30 → 2018-02-19🇩🇪 Germany

Studying: Healthy · NCT03175211

About this trial

The primary objective of this trial is to investigate the safety and tolerability of BI 456906 in healthy subjects following single rising doses. The secondary objective is the exploration of the pharmacokinetics including dose proportionality, and pharmacodynamics (PD) of BI 456906 after single dosing

A Study in Healthy Men to Test How BI 456906 is Processed in the Body

CompletedPhase 16 peopleBoehringer Ingelheim2022-07-04 → 2022-11-17🇳🇱 Netherlands

Studying: Healthy · NCT05421338

About this trial

This trial is intended to examine the basic pharmacokinetics of BI 456906 and total \[14C\]-radioactivity, including mass balance, excretion pathways and metabolism following a single subcutaneous (SC) dose of BI 456906 (C-14) in (otherwise) healthy male volunteers with normal body weight, overweight or obesity.

Registered trials include ones that haven't published results yet. Trials are matched on the compound's name and code names (Survodutide, BI 456906) in the listed interventions.