NCT06309992CompletedPhase 3
Multicentre, Randomised, Double-blind, Placebo-controlled, 48-week, Phase III Trial to Evaluate the Efficacy and Safety of Survodutide Administered Subcutaneously in Participants With Overweight or Obesity and Presumed or Confirmed Nonalcoholic Steatohepatitis (NASH)
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 218
- Locations
- 69
- Primary Endpoint
- Relative change (%) in body weight [kg] from baseline to Week 48
Study Overview
Brief Summary
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. Participants are put into 2 groups randomly, which means by chance. 1 group gets different doses of survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Every participant has a 2 in 3 chance of getting survodutide. Participants and doctors do not know who is in which group. Participants inject survodutide or placebo under their skin once a week for about 1 year. In addition to the study medicine, all participants receive counselling to make changes to their diet and to exercise regularly.
Participants are in the study for about 1 year and 3 months. During this time, it is planned that participants visit the study site up to 14 times and receive 3 phone calls by the site staff. The doctors check participants' health and take note of any unwanted effects. The participants' body weight is regularly measured. At 3 of the visits, the participants' liver is measured using different imaging methods. The results are compared between the groups to see whether the treatment works.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 of the following weight-related comorbidities at screening:
- •Hypertension (defined as repeated, i.e. at least 3 measurements in resting condition, Systolic Blood Pressure (SBP) values of ≥140 mmHg and/or Diastolic Blood Pressure (DBP) values of ≥90 mmHg in the absence of anti-hypertensive treatment, or intake of at least 1 antihypertensive drug to maintain a normotensive blood pressure)
- •Dyslipidaemia (defined as at least 1 lipid-lowering treatment required to maintain 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), or high-density lipoprotein (HDL) cholesterol <40 mg/dL (<1.0 mmol/L) for men or HDL 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 or cerebrovascular revascularisation procedure [e.g. carotid endarterectomy and/or stent], MI, coronary artery disease, or peripheral vascular disease)
- •Type 2 diabetes mellitus (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)
- •History of at least one self-reported unsuccessful dietary effort to lose body weight Further inclusion criteria apply.
Exclusion Criteria
- •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.
- •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, Alpha-1 Antitrypsin (A1At) deficiency, history of liver transplantation). Hepatitis B and C testing will be done at Visit
- •Participants with positive hepatitis B surface antigen (HBsAg) should be excluded. Participants treated for hepatitis C must have a negative ribonucleic acid (RNA) test at screening and also be Hepatitis C virus (HCV) RNA negative for at least 3 years prior to screening in order to be eligible for the trial. Trial participants 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 non-invasive tests assessed at screening (enhanced liver fibrosis (ELF) ≥11.3 or Fibrosis (FIB)-4 ≥3.48 or FibroScan® VCTE™ ≥20 kPa or MRE ≥4.68 kPa) or a history of cirrhosis.
- •Current decompensated liver disease or previous hepatic decompensation (ascites, spontaneous bacterial peritonitis, portal hypertension bleeding, hepatic encephalopathy, hepatorenal syndrome).
- •Evidence of portal hypertension (e.g. splenomegaly, oesophageal varices, or other portosystemic collateral pathways).
- •Further exclusion criteria apply.
Arms & Interventions
Placebo arm
Placebo Comparator
Intervention: Placebo (Combination Product)
Treatment arm
Experimental
Intervention: Survodutide (Combination Product)
Outcomes
Primary Outcomes
Relative change (%) in body weight [kg] from baseline to Week 48
Time Frame: at baseline, at week 48
Relative reduction in liver fat content of at least 30% from baseline to Week 48 (yes/no) assessed by magnetic resonance imaging proton density fat fraction (MRI-PDFF) [%]
Time Frame: at baseline, at week 48
Secondary Outcomes
- Relative change in liver volume [mL] from baseline to Week 48 measured using MRI(at baseline, at week 48)
- Absolute change in liver volume [mL] from baseline to Week 48 measured using MRI(at baseline, at week 48)
- Absolute change from baseline to Week 48 in liver stiffness [kPa] assessed by magnetic resonance elastography (MRE)(at baseline, at week 48)
- Relative change from baseline to Week 48 in liver stiffness [kPa] assessed by magnetic resonance elastography (MRE)(at baseline, at week 48)
- Absolute change from baseline to Week 48 in liver fat content assessed by MRI-PDFF [%](at baseline, at week 48)
- Relative change (%) from baseline to Week 48 in liver fat content assessed by MRI-PDFF [%](at baseline, at week 48)
- Reduction from baseline to Week 48 in Iron corrected T1 (cT1) [ms] levels of ≥80 ms (yes/no)(at baseline, at week 48)
- Absolute change from baseline to Week 48 in alanine amino transferase (ALT) [U/L] levels(at baseline, at week 48)
- Relative change from baseline to Week 48 in alanine amino transferase (ALT) [U/L] levels(at baseline, at week 48)
- Absolute change from baseline to Week 48 in waist circumference [cm](at baseline, at week 48)
- Relative change from baseline to Week 48 in waist circumference [cm](at baseline, at week 48)
- Absolute change from baseline to Week 48 in Homeostasis Model Assessment -Insulin Resistance (HOMA-IR) (Fasting Plasma Insulin (FPI) [mlU/L] · Fasting Plasma Glucose (FPG) [mmol/L]/22.5)(at baseline, at week 48)
- Relative change from baseline to Week 48 in HOMA-IR (FPI [mlU/L] · FPG [mmol/L]/22.5)(at baseline, at week 48)
Investigators
Study Sites (69)
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