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BI 456906

BI 456906, also called survodutide, is a medicine being studied in clinical trials for conditions linked to body weight and metabolism. Trials are looking at how it helps with weight loss, how it affects blood sugar in type 2 diabetes, and how safe it is for the heart and kidneys. Other studies focus on how the body absorbs the drug, and how liver or kidney problems may change drug levels in the blood.

Table of Contents

1) What is BI 456906 (Survodutide)?

BI 456906 is an investigational medicine being tested in clinical trials. In many trials it is also called survodutide. The studies provided describe BI 456906 as a solution for injection that is usually given as a subcutaneous injection (an injection under the skin).

Across trials, researchers are exploring BI 456906 for weight-related conditions and metabolic health, including overweight/obesity, type 2 diabetes, kidney disease outcomes, and liver disease outcomes. Some trials are also focused on very basic questions, such as how much of the drug gets into the blood and how the body removes it.

[1][2]

2) How BI 456906 is given in studies

Most clinical trials listed use injections under the skin. Common patterns include:

  • Once-weekly dosing: Many studies give BI 456906 once a week, especially weight loss and safety studies.

  • Titration (dose escalation): Several studies increase the dose slowly over time. This is often done to improve tolerability, meaning to help participants stay on treatment without side effects forcing them to stop or reduce the dose.

  • Single-dose studies: Some early Phase I trials give only one dose, mainly to measure drug levels in blood and short-term safety.

[3][4]

3) What conditions are being studied

Based on the included trial records, BI 456906 is being studied in:

  • Obesity and overweight (including people without diabetes and specific regional studies such as in Chinese participants)

  • Type 2 diabetes mellitus (including people on metformin with high blood sugar)

  • Chronic kidney disease (with albuminuria) and separate studies in renal impairment to understand drug levels

  • Liver diseases, including cirrhosis with varying severity and a Phase III trial in presumed/confirmed NASH

[5][6][7]

4) Weight loss trials in overweight or obesity

Several trials are designed to test whether BI 456906 helps people lose weight and improve body measurements such as waist size.

Examples of what these weight-focused trials measure include:

  • Percentage change in body weight from baseline to a specific time point (for example Week 46, Week 52, or Week 76, depending on the trial).

  • Whether participants reach weight loss milestones such as losing at least 5%, 10%, 15%, or 20% of their starting weight.

  • Waist circumference changes (an abdominal measurement often used as a marker of central body fat).

  • Blood pressure changes (systolic and diastolic).

One Phase II dose-finding study in obesity/overweight (without diabetes) compares multiple BI 456906 doses with placebo over 46 weeks, focusing on percent body weight change and weight-loss thresholds (≥5%, ≥10%, ≥15%).

[1]

A Phase III study in Chinese participants with overweight/obesity compares two doses (3.6 mg and 4.8 mg) against placebo and measures weight change and multiple cardiometabolic measures at Week 52.

[8]

There are also Phase III European registry trials described for people with overweight/obesity without type 2 diabetes, where the main endpoints include percent weight change and achieving ≥5% weight loss by Week 76, with additional weight-loss thresholds and waist circumference and blood pressure among secondary endpoints.

[9]

5) Trials in type 2 diabetes

BI 456906 is also studied in adults with type 2 diabetes mellitus. In one Phase II dose-finding trial, participants who take metformin but still have high blood sugar receive BI 456906 (different dose groups) or placebo, and there is also an open-label semaglutide group.

Key measurements in the type 2 diabetes study include:

  • HbA1c change (HbA1c is a blood test showing average blood sugar over the past 2–3 months)

  • Change in body weight and waist circumference

  • Percentage of participants reaching ≥5% or ≥10% weight loss over 16 weeks

[5]

In addition, a Phase III European registry trial is described for people with overweight/obesity and type 2 diabetes. Its primary endpoints include percent body weight change and achieving ≥5% weight loss by Week 76, with HbA1c included among secondary endpoints.

[10]

6) Kidney-focused trials (CKD and renal impairment)

Kidney-related research with BI 456906 appears in two different ways: (1) outcome trials in people who already have kidney disease, and (2) drug-level studies in people with reduced kidney function.

CKD outcome trial (albuminuria reduction)

The ARTIST-CKD trial studies weekly subcutaneous BI 456906 (survodutide) in people with chronic kidney disease and elevated albuminuria. The primary outcome is change in first morning void UACR (urine albumin-to-creatinine ratio), averaged at weeks 32 and 36 to reduce day-to-day variability. Secondary outcomes include eGFR and measured GFR using iohexol in a subset.

[6]

Renal impairment PK study

Another study gives a single BI 456906 dose to participants with normal kidney function and to participants with mild, moderate, or severe renal impairment. The goal is to compare BI 456906 blood levels using measures like AUC and Cmax, and to record drug-related adverse events.

[11]

7) Liver-focused trials (cirrhosis/hepatic impairment and NASH)

Trials address liver health in two main ways:

  • How liver impairment changes BI 456906 levels and tolerability

  • Whether BI 456906 reduces liver fat and weight in people with NASH

Hepatic impairment and cirrhosis study

A two-part study compares drug levels after a single dose in healthy people versus people with cirrhosis grouped by Child-Turcotte-Pugh (CTP) class (A, B, C). It also studies longer exposure in people with overweight/obesity with or without cirrhosis, using multiple weekly doses over 28 weeks with a titration plan, and measures treatment-emergent adverse events.

[12]

NASH Phase III trial

A Phase III trial is described for participants with overweight/obesity and presumed or confirmed non-alcoholic steatohepatitis (NASH). It evaluates BI 456906 once weekly as an add-on to reduced-calorie diet and increased physical activity versus placebo. The two primary goals are:

  • Achieving at least a 30% relative reduction in liver fat measured by MRI-PDFF at Week 48

  • Improving relative change in body weight from baseline to Week 48

[7]

8) Heart and cardiovascular safety studies

Because new medicines can sometimes affect the heart, several BI 456906 trials focus on cardiovascular safety.

Heart rhythm (QTcI) safety study

One trial evaluates cardiac safety parameters in adults with overweight/obesity using ECG testing. A key outcome is the time-matched change from baseline in QTcI during BI 456906 dosing. The trial uses moxifloxacin as a “positive control,” which means it is known to change heart rhythm in a detectable way and helps confirm that the ECG analysis can pick up changes.

[2]

Phase 3 cardiovascular outcomes safety study (EU registry)

A Phase 3, randomized, double-blind, event-driven study is described in people with overweight/obesity and established cardiovascular disease or chronic kidney disease and/or at least two weight-related cardiovascular risk factors. The primary endpoint is time to first occurrence of a composite of serious cardiovascular outcomes (including cardiovascular death, non-fatal stroke, non-fatal myocardial infarction, ischemia-related coronary revascularization, or heart failure events).

[13]

9) Brain and receptor imaging studies

Some studies use imaging to understand how BI 456906 may affect biological pathways linked to appetite and metabolism.

Brain activity study using fMRI

One Phase I study in people with overweight/obesity tests single doses of BI 456906 alone, another drug (BI 1820237) alone, and the combination, compared with placebo. The main outcome is change in brain activity measured as BOLD signal on functional MRI (fMRI) in response to food-related visual stimuli and nutrient-specific food preference tasks.

[14]

Receptor occupancy study using PET/MRI

Another Phase I study compares BI 456906 with semaglutide in people with obesity and uses injected tracers with imaging to measure:

  • Glucagon receptor occupancy in the liver (PET)

  • GLP-1 receptor occupancy in the pancreas (PET)

[15]

10) Studies on drug levels: PK, metabolism, and formulations

Many early-stage studies focus on how BI 456906 is absorbed and processed, often using blood sampling over time to calculate PK measurements like AUC and Cmax.

Single rising dose safety/PK study in healthy volunteers

A Phase I trial evaluates safety and tolerability after single rising subcutaneous doses in healthy male subjects, and explores pharmacokinetics and pharmacodynamics after single dosing.

[4]

Multiple dose titration scheme trials

Several studies in obesity/overweight (including a study in healthy Japanese men with BMI 23–40 kg/m²) focus on different dose escalation schedules and look at how many participants withdraw from up-titration, along with PK measures after dosing.

[3][16]

Metabolism and excretion (mass balance) study

A Phase I study uses BI 456906 (C-14), a radiolabeled version of the drug, to track drug-related material and understand mass balance, excretion pathways (urine and feces), and metabolism after a single dose.

[17]

Formulation (bioavailability) comparison studies

Two studies compare different BI 456906 formulations in healthy participants to evaluate relative bioavailability using AUC and Cmax. One compares formulation A versus B2 in a two-period crossover design, and another compares formulation A with formulations B and C in a three-period crossover design.

[18][19]

11) Drug interaction study with an oral contraceptive

One Phase I study in otherwise healthy women with overweight/obesity examines whether multiple doses of BI 456906 change blood levels of the contraceptive Microgynon®, which contains ethinylestradiol and levonorgestrel. The main outcomes are AUC and Cmax for each hormone when taken alone versus during BI 456906 dosing.

[20]

12) Understanding common trial measurements

Clinical trials use specific measurements to answer specific questions. Here are common ones seen in these BI 456906 trials:

  • HbA1c: A long-term blood sugar marker (average over ~2–3 months). Trials in type 2 diabetes use it to assess blood sugar control.

  • AUC and Cmax: Blood level measurements used in pharmacokinetics. AUC reflects overall exposure; Cmax reflects the peak concentration.

  • QTcI: An ECG-based heart rhythm measurement corrected for heart rate on an individual basis. Changes are monitored to evaluate cardiac safety.

  • UACR: A urine test for albumin leakage from the kidneys. Lower UACR can indicate improved kidney-related outcomes in albuminuria studies.

  • MRI-PDFF: An imaging method that estimates liver fat percentage. NASH trials use it to evaluate liver fat reduction.

[5][2][6][7]
Topic What the BI 456906 trials are studying
Drug name BI 456906 (also called survodutide)
Main uses being researched Weight loss in overweight/obesity; blood sugar control and weight in type 2 diabetes; kidney outcomes in CKD with albuminuria; liver fat and weight in NASH
How it is given Mostly subcutaneous injection (under the skin), often once weekly; some studies use dose titration (stepwise increases)
Common effectiveness measures Percent body weight change; ≥5/10/15/20% weight loss rates; waist circumference; HbA1c; liver fat by MRI-PDFF; albuminuria by UACR
Safety focus areas General side effects (TEAEs); heart rhythm safety using ECG/QTcI; cardiovascular outcomes in a large Phase 3 safety study
Special population studies People with liver impairment/cirrhosis; people with renal impairment; women using an oral contraceptive
Studies in healthy volunteers Single-dose safety and pharmacokinetics; metabolism/excretion using radiolabeled drug; formulation bioavailability comparisons

FAQ

  • What is BI 456906 and does it have another name? BI 456906 is an investigational medicine that is given as an injection under the skin. In many trials it is also called survodutide. Some studies look at different “formulations,” meaning different versions of how the same medicine is prepared for injection.
  • What conditions are being studied with BI 456906? Clinical trials are studying BI 456906 in people with overweight or obesity, in adults with type 2 diabetes, in people with chronic kidney disease (especially with high urine albumin), and in people with liver disease such as cirrhosis or suspected/confirmed non-alcoholic steatohepatitis (NASH).
  • How is BI 456906 usually given in these trials? Most studies give BI 456906 as a subcutaneous injection (an injection under the skin). Many trials use once-weekly dosing. Some studies use a “titration” plan, meaning the dose starts low and is increased step-by-step to help people tolerate treatment.
  • What do researchers measure to see if BI 456906 is working? Depending on the study, researchers may measure body weight change, the percentage of people who lose at least 5%, 10%, 15%, or 20% of their starting weight, waist circumference, blood pressure, and blood sugar markers such as HbA1c. Some trials also measure kidney markers like UACR (albumin in urine) or imaging-based liver fat reduction using MRI-PDFF.
  • Why are there studies in healthy volunteers and studies in people with liver or kidney problems? Studies in healthy volunteers help researchers understand basic safety and how the drug moves through the body (pharmacokinetics). Studies in people with liver or kidney impairment check whether these conditions change drug levels in the blood or affect tolerability, which is important because obesity and liver/kidney problems often occur together.

Ongoing Clinical Trials on BI 456906

  • A study to evaluate the effect of survodutide on protein levels in the urine for patients with chronic kidney disease

    Not yet recruiting

    1
    Investigated diseases:
    Investigated drugs:
    Germany The Netherlands Spain

  • Study on the Effectiveness of Survodutide for Weight Loss in Patients with Type 2 Diabetes and Obesity

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Czechia Denmark Finland Germany Greece +5

  • Study on the Effectiveness of Survodutide for Weight Loss in Adults with Obesity Without Diabetes

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Finland Germany The Netherlands Poland Sweden

  • Study on the Effect of Survodutide on Heart Safety in Patients with Obesity and Cardiovascular or Kidney Disease

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Bulgaria Czechia Denmark Finland +11

  • Study to Evaluate the Effectiveness of Survodutide in Reducing Liver Fat and Weight in Patients with Obesity or Overweight and Non-Alcoholic Steatohepatitis (NASH)

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Germany The Netherlands Spain

Glossary

  • BI 456906: The study drug being tested in multiple clinical trials. It is given as an injection under the skin and is being developed for conditions related to body weight and metabolism.
  • Survodutide: Another name used for BI 456906 in several trials.
  • Subcutaneous injection (SC): An injection given under the skin (not into a vein). Many BI 456906 studies use weekly subcutaneous injections.
  • Formulation: A specific version of how a medicine is prepared. Trials compare different BI 456906 formulations (for example, formulation A, B, B2, or C) to see if they lead to similar drug levels in the body.
  • Relative bioavailability: A comparison of how much medicine gets into the bloodstream from one formulation versus another. If two formulations have similar bioavailability, they may be absorbed in a similar way.
  • Pharmacokinetics (PK): How the body absorbs, distributes, and removes a medicine. PK is often measured using blood samples over time.
  • AUC (Area Under the Curve): A blood-test based measure that estimates overall drug exposure over time. Higher AUC usually means more total exposure to the drug during the measured period.
  • AUC0-tz: AUC measured from time zero (dosing) to the last time point where the drug level can still be reliably measured.
  • AUC0-∞: AUC measured from time zero and mathematically extended to “infinity” to estimate total drug exposure over time.
  • Cmax: The highest measured drug concentration in the blood after a dose.
  • Metabolism: How the body breaks down a medicine into other substances (metabolites). Some studies use special methods to track this.
  • Mass balance study: A study that tracks where a drug (and its breakdown products) go in the body and how they leave the body (for example, through urine and stool).
  • C-14 (14C) radiolabeled drug: A form of the drug tagged with a small amount of radioactive carbon so researchers can track drug-related material in urine and stool to understand elimination pathways.
  • Excretion pathways: The routes by which the body removes a drug, mainly through urine and feces (stool).
  • Treatment-emergent adverse event (TEAE): Any unwanted health problem that happens after a participant starts the study treatment, whether or not it is definitely caused by the drug.
  • Tolerability: How well people can stay on a medicine at planned doses without having side effects that force dose reduction or stopping treatment.
  • Titration / up-titration: A planned increase in dose over time, usually starting with a low dose to improve tolerability.
  • Placebo: A treatment that looks like the real medicine but has no active drug. It is used to compare effects fairly.
  • Randomized: Participants are assigned to treatment groups by chance, which helps make comparisons fair.
  • Double-blind: A study design where participants and study staff do not know who is receiving the active drug versus placebo (in the blinded parts of a trial).
  • Open-label: A study design where the participant and researchers know which treatment is being given.
  • Overweight / Obesity: Weight categories often defined using BMI. Many BI 456906 trials include adults with overweight or obesity, commonly using BMI cutoffs like 27, 28, or 30 kg/m² depending on the study.
  • BMI (Body Mass Index): A number calculated from height and weight (kg/m²). It is commonly used in trials to define overweight or obesity and decide who can join.
  • Waist circumference: A measurement around the abdomen. It is used as an indicator of abdominal (central) fat.
  • Type 2 diabetes mellitus (T2DM): A condition where blood sugar is too high because the body does not use insulin well and may not make enough insulin. Some BI 456906 trials study blood sugar control and weight in T2DM.
  • HbA1c: A blood test showing average blood sugar over about the past 2–3 months. Trials measure changes in HbA1c to evaluate diabetes control.
  • Chronic kidney disease (CKD): Long-term loss of kidney function. One trial studies whether BI 456906 can reduce albuminuria in CKD.
  • Albuminuria: Albumin (a protein) leaking into urine, which can be a sign of kidney damage.
  • UACR (Urine Albumin-to-Creatinine Ratio): A urine test used to measure albuminuria. It compares urine albumin to urine creatinine to help correct for urine concentration.
  • eGFR (estimated Glomerular Filtration Rate): A calculated estimate of how well the kidneys filter blood, often based on creatinine and sometimes cystatin C.
  • Iohexol measured GFR: A more direct test of kidney filtration using a tracer called iohexol. One CKD study measures this in a subset of participants.
  • Renal impairment: Reduced kidney function. One study compares BI 456906 blood levels in people with mild, moderate, or severe renal impairment versus normal kidney function.
  • Hepatic impairment: Reduced liver function. One study examines BI 456906 levels and tolerability in people with cirrhosis and different levels of liver impairment.
  • Cirrhosis: Severe scarring of the liver. Trials group cirrhosis severity using Child-Turcotte-Pugh classes.
  • Child-Turcotte-Pugh (CTP) Class A/B/C: A system used to group how severe cirrhosis is. Class A is less severe and Class C is more severe.
  • NASH (Non-alcoholic steatohepatitis): A liver disease linked to fat in the liver plus inflammation and liver cell injury. A Phase III trial studies whether BI 456906 reduces liver fat and body weight in people with overweight/obesity and presumed or confirmed NASH.
  • MRI-PDFF: An MRI-based measurement of liver fat (Proton Density Fat Fraction). It is used in the NASH trial to measure liver fat reduction.
  • MRE (Magnetic Resonance Elastography): An imaging test that estimates liver stiffness, which can relate to liver scarring (fibrosis).
  • ECG: Electrocardiogram, a test that records the heart’s electrical activity. It is used in a cardiac safety study of BI 456906.
  • QT interval / QTcI: The QT interval is part of the ECG tracing. QTcI is the QT interval corrected for heart rate using an individual method. Changes in QTcI can suggest risk for abnormal heart rhythms.
  • Moxifloxacin (positive control): An antibiotic known to change heart rhythm in a predictable way. In one study it is used as a positive control to confirm the heart rhythm testing can detect changes.
  • fMRI and BOLD signal: Functional MRI measures brain activity. BOLD (Blood Oxygen Level Dependent) signal is a brain imaging signal related to changes in blood oxygen. One trial studies how BI 456906 (alone or with another drug) affects brain responses to food-related stimuli.
  • PET imaging and tracer: Positron emission tomography (PET) uses an injected tracer to visualize activity in the body. One obesity trial uses PET and MRI to measure receptor occupancy in liver and pancreas after BI 456906 or semaglutide.
  • Receptor occupancy: How much of a specific receptor is bound or “occupied” by a drug (or measured indirectly using tracers). This can help understand how strongly a drug engages its targets.
  • Semaglutide: A medicine already used for body weight reduction and also for type 2 diabetes. Several BI 456906 trials compare results with semaglutide or use it as an active comparator.
  • Oral contraceptive (ethinylestradiol/levonorgestrel): A birth control pill combination used in one study to test whether BI 456906 changes the blood levels of contraceptive hormones.

References

  1. https://clinicaltrials.gov/study/NCT04667377
  2. https://clinicaltrials.gov/study/NCT06200467
  3. https://clinicaltrials.gov/study/NCT03591718
  4. https://clinicaltrials.gov/study/NCT03175211
  5. https://clinicaltrials.gov/study/NCT04153929
  6. https://clinicaltrials.eu/trial/a-study-to-evaluate-the-effect-of-survodutide-on-protein-levels-in-the-urine-for-patients-with-chronic-kidney-disease/
  7. https://clinicaltrials.eu/trial/study-to-evaluate-the-effectiveness-of-survodutide-in-reducing-liver-fat-and-weight-in-patients-with-obesity-or-overweight-and-non-alcoholic-steatohepatitis-nash/
  8. https://clinicaltrials.gov/study/NCT06214741
  9. https://clinicaltrials.eu/trial/study-on-the-effectiveness-of-survodutide-for-weight-loss-in-adults-with-obesity-without-diabetes/
  10. https://clinicaltrials.eu/trial/study-on-the-effectiveness-of-survodutide-for-weight-loss-in-patients-with-type-2-diabetes-and-obesity/
  11. https://clinicaltrials.gov/study/NCT06352411
  12. https://clinicaltrials.gov/study/NCT05296733
  13. https://clinicaltrials.eu/trial/study-on-the-effect-of-survodutide-on-heart-safety-in-patients-with-obesity-and-cardiovascular-or-kidney-disease/
  14. https://clinicaltrials.gov/study/NCT06352424
  15. https://clinicaltrials.gov/study/NCT05202353
  16. https://clinicaltrials.gov/study/NCT04384081
  17. https://clinicaltrials.gov/study/NCT05421338
  18. https://clinicaltrials.gov/study/NCT07071974
  19. https://clinicaltrials.gov/study/NCT06772532
  20. https://clinicaltrials.gov/study/NCT05896384