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

Key inclusion criteria:

• Age ≥18 years at the time of signing informed consent, and at least the legal age ofconsent in countries where it is >18 years

• BMI ≥30 kg/m², OR BMI ≥27 kg/m² and at least one of the following weight-relatedcomorbidities at screening:

• Hypertension (defined as repeated, i.e. at least 3 measurements in restingcondition, Systolic Blood Pressure (SBP) values of ≥140 mmHg and/or DiastolicBlood Pressure (DBP) values of ≥90 mmHg in the absence of anti-hypertensivetreatment, or intake of at least 1 antihypertensive drug to maintain anormotensive blood pressure)

• Dyslipidaemia (defined as at least 1 lipid-lowering treatment required tomaintain normal blood lipid levels, or lowdensity lipoprotein (LDL) cholesterol ≥160 mg/dL (≥4.1 mmol/L) or triglycerides ≥150 mg/dL (≥1.7 mmol/L), orhigh-density lipoprotein (HDL) cholesterol <40 mg/dL (<1.0 mmol/L) for men orHDL cholesterol <50 mg/dL (<1.3 mmol/L) for women

• Obstructive sleep apnoea

• Cardiovascular disease (e.g. heart failure with New York Heart Association (NYHA) functional class II-III, history of ischaemic or haemorrhagic stroke orcerebrovascular revascularisation procedure [e.g. carotid endarterectomy and/orstent], MI, coronary artery disease, or peripheral vascular disease)

• Type 2 diabetes mellitus (T2DM) (diagnosed at least 180 days prior toscreening, with glycated haemoglobin [HbA1c] ≥6.5% (48 mmol/mol) and <10% (86mmol/mol) as measured by the central laboratory at screening)

• History of at least one self-reported unsuccessful dietary effort to lose bodyweight Further inclusion criteria apply.

Key exclusion criteria:

• Current or history of significant alcohol consumption (defined as intake of >210g/week in men and >140 g/week in women on average over a consecutive period of morethan 3 months) or inability to reliably quantify alcohol consumption based on theinvestigator's judgement within the last 5 years.

• Intake of medications associated with liver injury, hepatic steatosis orsteatohepatitis.

• History of other chronic liver diseases (e.g. viral hepatitis, autoimmune liverdisease, primary biliary cholangitis , primary sclerosing cholangitis, Wilson'sdisease, hemochromatosis, Alpha-1 Antitrypsin (A1At) deficiency, history of livertransplantation). Hepatitis B and C testing will be done at Visit 1. Participantswith positive hepatitis B surface antigen (HBsAg) should be excluded. Participantstreated for hepatitis C must have a negative ribonucleic acid (RNA) test atscreening and also be Hepatitis C virus (HCV) RNA negative for at least 3 yearsprior to screening in order to be eligible for the trial. Trial participants withpositive HCV antibody and no history of HCV treatment require a negative HCV RNAtest at screening to be eligible for the trial.

• Cirrhosis based on clinical assessment, abdominal imaging, liver histology ornon-invasive tests assessed at screening (enhanced liver fibrosis (ELF) ≥11.3 orFibrosis (FIB)-4 ≥3.48 or FibroScan® VCTE™ ≥20 kPa or MRE ≥4.68 kPa) or a history ofcirrhosis.

• Current decompensated liver disease or previous hepatic decompensation (ascites,spontaneous bacterial peritonitis, portal hypertension bleeding, hepaticencephalopathy, hepatorenal syndrome).

• Evidence of portal hypertension (e.g. splenomegaly, oesophageal varices, or otherportosystemic collateral pathways).

Further exclusion criteria apply.