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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
EU CTIS ID: 2023-505303-23-00
What this study is testing
This trial aims to provide evidence of the efficacy, safety, and tolerability of survodutide administered once weekly as an adjunct to a reduced-calorie diet and increased physical activity, in comparison with placebo, in participants with presumed or onfirmed NASH and obesity (BMI ≥30 kg/m²) or overweight (BMI ≥27 kg/m2) with at least one of the following weight-related complications (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea, cardiovascular disease or T2DM. The primary objective is to demonstrate superiority of survodutide in: - Reduction in liver fat content assessed by MRI-PDFF, defined as ≥30% from baseline at Week 48 (odds ratio, survodutide vs. placebo), AND - The difference in adjusted means of relative change (%) in body weight from baseline to Week 48 (survodutide vs. placebo)
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥18 years at the time of signing informed consent, and at least the legal age of consent in countries where it is >18 years
- BMI ≥30 kg/m², OR BMI ≥27 kg/m² and at least one weight-related comorbidity at screening: • Hypertension (defined as repeated, i.e. at least 3 measurements in resting condition, SBP values of ≥140 mmHg and/or DBP values of ≥90 mmHg in the absence of antihypertensive treatment, or intake of at least 1 anti-hypertensive drug to maintain a normotensive blood pressure) • Dyslipidaemia (defined as at least 1 lipid-lowering treatment required to maintain normal blood lipid levels, or low-density lipoprotein [LDL] ≥160 mg/dL [≥4.1 mmol/L] or triglycerides ≥150 mg/dL [≥1.7 mmol/L], or high-density lipoprotein (HDL] <40 mg/dL (<1.0 mmol/L] for men or HDL<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 or cerebrovascular revascularisation procedure [e.g. carotid endarterectomy and/or stent], MI, coronary artery disease, or peripheral vascular disease) • T2DM (diagnosed at least 180 days prior to screening, with glycated haemoglobin [HbA1c] ≥6.5% [48 mmol/mol] and <10% [86 mmol/mol] as measured by the central laboratory at screening)
- Presumed/confirmed NASH: Evidence of hepatic steatosis (defined by an MRIPDFF ≥8% at screening) with the exclusion of secondary causes of hepatic fat accumulation such as significant alcohol consumption, other chronic liver diseases and/or steatogenic medications, AND at least one of the following: • MRE ≥2.61 and <4.68 kPa at screening, OR • MAST score ≥0.242 at screening, when MAST score = exp(MAST)/(1+exp[MAST]), where MAST = -12.17 + 7.07 logMRE + 0.037 PDFF + 3.55 log AST OR • FAST score ≥0.5 at screening, OR • FibroScan® VCTE™ ≥8 kPa and <20 kPa at screening, OR • FIB-4 score ≥2.67 and <3.48 at screening, OR • ELF score >7.7 and <11.3 at screening, OR • cT1 ≥875 ms at screening, OR • Recent liver biopsy (within 3 years of screening) consistent with NASH (defined as the presence of steatosis, inflammation, and ballooning) with stage ≤3 fibrosis according to the NASH Clinical Research Network classification.
- History of at least one self-reported unsuccessful dietary effort to lose body weight
You likely can't join if
- Current or history of significant alcohol consumption (defined as intake of >210 g/week in men and >140 g/week in women on average over a consecutive period of more than 3 months) or inability to reliably quantify alcohol consumption based on the investigator’s judgement within the last 5 years.
- Previous or planned (during the trial period) treatment for obesity with surgery or a weight loss device, or prior surgery of the GI tract that could interfere with body weight. The following are allowed: (1) liposuction and/or abdominoplasty, if performed >1 year before screening, (2) lap banding, if the band has been removed >1 year before screening, (3) intragastric balloon, if the balloon has been removed >1 year before screening, (4) duodenal-jejunal bypass sleeve, if the sleeve has been removed >1 year before screening (5) appendectomy, (6) simple hernia repair, or (7) cholecystectomy.
- Obesity induced by other endocrinologic disorders (i.e. Cushing Syndrome) or diagnosed monogenetic or syndromic forms of obesity (i.e. melanocortin 4 receptor deficiency, leptin deficiency, or Prader Willi Syndrome)
- Intake of medications associated with liver injury, hepatic steatosis or steatohepatitis
- History of other chronic liver diseases (e.g. viral hepatitis, autoimmune liver disease, primary biliary cholangitis , primary sclerosing cholangitis, Wilson’s disease, hemochromatosis, A1At deficiency, history of liver transplantation). Hepatitis B and C testing will be done at Visit 1. Participants with positive HBsAg should be excluded. Participants treated for hepatitis C must have a negative RNA test at screening and also be HCV RNA negative for at least 3 years prior to screening in order to be eligible for the trial. Trial patients with positive HCV antibody and no history of HCV treatment require a negative HCV RNA test at screening to be eligible for the trial.
- Cirrhosis based on clinical assessment, abdominal imaging, liver histology or noninvasive tests assessed at screening (ELF ≥11.3, FIB4 ≥3.48, FibroScan® VCTE™ ≥20 kPa, or MRE ≥4.68 kPa), or history of cirrhosis.
See the full eligibility criteria
Who can join
- Age ≥18 years at the time of signing informed consent, and at least the legal age of consent in countries where it is >18 years
- BMI ≥30 kg/m², OR BMI ≥27 kg/m² and at least one weight-related comorbidity at screening: • Hypertension (defined as repeated, i.e. at least 3 measurements in resting condition, SBP values of ≥140 mmHg and/or DBP values of ≥90 mmHg in the absence of antihypertensive treatment, or intake of at least 1 anti-hypertensive drug to maintain a normotensive blood pressure) • Dyslipidaemia (defined as at least 1 lipid-lowering treatment required to maintain normal blood lipid levels, or low-density lipoprotein [LDL] ≥160 mg/dL [≥4.1 mmol/L] or triglycerides ≥150 mg/dL [≥1.7 mmol/L], or high-density lipoprotein (HDL] <40 mg/dL (<1.0 mmol/L] for men or HDL<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 or cerebrovascular revascularisation procedure [e.g. carotid endarterectomy and/or stent], MI, coronary artery disease, or peripheral vascular disease) • T2DM (diagnosed at least 180 days prior to screening, with glycated haemoglobin [HbA1c] ≥6.5% [48 mmol/mol] and <10% [86 mmol/mol] as measured by the central laboratory at screening)
- Presumed/confirmed NASH: Evidence of hepatic steatosis (defined by an MRIPDFF ≥8% at screening) with the exclusion of secondary causes of hepatic fat accumulation such as significant alcohol consumption, other chronic liver diseases and/or steatogenic medications, AND at least one of the following: • MRE ≥2.61 and <4.68 kPa at screening, OR • MAST score ≥0.242 at screening, when MAST score = exp(MAST)/(1+exp[MAST]), where MAST = -12.17 + 7.07 logMRE + 0.037 PDFF + 3.55 log AST OR • FAST score ≥0.5 at screening, OR • FibroScan® VCTE™ ≥8 kPa and <20 kPa at screening, OR • FIB-4 score ≥2.67 and <3.48 at screening, OR • ELF score >7.7 and <11.3 at screening, OR • cT1 ≥875 ms at screening, OR • Recent liver biopsy (within 3 years of screening) consistent with NASH (defined as the presence of steatosis, inflammation, and ballooning) with stage ≤3 fibrosis according to the NASH Clinical Research Network classification.
- History of at least one self-reported unsuccessful dietary effort to lose body weight
What rules you out
- Current or history of significant alcohol consumption (defined as intake of >210 g/week in men and >140 g/week in women on average over a consecutive period of more than 3 months) or inability to reliably quantify alcohol consumption based on the investigator’s judgement within the last 5 years.
- Previous or planned (during the trial period) treatment for obesity with surgery or a weight loss device, or prior surgery of the GI tract that could interfere with body weight. The following are allowed: (1) liposuction and/or abdominoplasty, if performed >1 year before screening, (2) lap banding, if the band has been removed >1 year before screening, (3) intragastric balloon, if the balloon has been removed >1 year before screening, (4) duodenal-jejunal bypass sleeve, if the sleeve has been removed >1 year before screening (5) appendectomy, (6) simple hernia repair, or (7) cholecystectomy.
- Obesity induced by other endocrinologic disorders (i.e. Cushing Syndrome) or diagnosed monogenetic or syndromic forms of obesity (i.e. melanocortin 4 receptor deficiency, leptin deficiency, or Prader Willi Syndrome)
- Intake of medications associated with liver injury, hepatic steatosis or steatohepatitis
- History of other chronic liver diseases (e.g. viral hepatitis, autoimmune liver disease, primary biliary cholangitis , primary sclerosing cholangitis, Wilson’s disease, hemochromatosis, A1At deficiency, history of liver transplantation). Hepatitis B and C testing will be done at Visit 1. Participants with positive HBsAg should be excluded. Participants treated for hepatitis C must have a negative RNA test at screening and also be HCV RNA negative for at least 3 years prior to screening in order to be eligible for the trial. Trial patients with positive HCV antibody and no history of HCV treatment require a negative HCV RNA test at screening to be eligible for the trial.
- Cirrhosis based on clinical assessment, abdominal imaging, liver histology or noninvasive tests assessed at screening (ELF ≥11.3, FIB4 ≥3.48, FibroScan® VCTE™ ≥20 kPa, or MRE ≥4.68 kPa), or history of cirrhosis.
- Current decompensated liver disease or previous hepatic decompensation (ascites, spontaneous bacterial peritonitis, portal hypertension bleeding, hepatic encephalopathy, hepatorenal syndrome).
- Previous or current evidence of portal hypertension (e.g. splenomegaly, oesophageal varices, or other portosystemic collateral pathways).
- Any of the following liver laboratory test abnormalities at screening: • Serum AST and/or ALT elevation ≥5x ULN • Total serum bilirubin concentration ≥1.2x ULN (except for cases of known Gilbert’s Syndrome) • Alkaline phosphatase >2x ULN • INR ≥1.3 (unless patient is on anticoagulants)
- Body weight variation (self-reported) >5% within 3 months before screening
- Medications for obesity within 3 months before screening
The study team makes the final eligibility decision.
Where it's taking place
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.