DelfaGLP-1 Atlas

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CompletedPhase 3

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)

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)

Asset

Survodutide

Subcutaneous · GLP-1 / glucagon dual

Listed sites

37

Recruiting sites

—

Enrollment

218

actual

Study population

MASH / NAFLD / liver fibrosis, Obesity / overweight

Key I/E criteria

•BMI ≥30•HbA1c ≥6.5%

Primary endpoints

•MRI-PDFF ≥30% responders•Body weight, % change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06309992
Org study ID1404-0056
Secondary ID2023-505303-23-00CTIS
Secondary IDU1111-1299-9925WHO registry

Timeline

Milestones

Study first posted2024-03-13actual
Study start2024-04-02actual
Primary completion2025-10-09actual
Study completion2025-12-02actual
Last update posted2026-04-30actual

Assets

Investigational agents

Survodutide

Study populations

Who this study enrolls

MASH / NAFLD / liver fibrosisObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Eligibility criteria

Key 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.

Key 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 1. 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.

Endpoints (15)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

MASH / liver
10
Weight & body composition
3
Glycemic / diabetes
2

Weight & body composition

3 endpoints
Primary/protocol endpoint

Relative change (%) in body weight [kg] from baseline to Week 48

Time frame:at baseline, at week 48

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Absolute change from baseline to Week 48 in waist circumference [cm]

Time frame:at baseline, at week 48

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Relative change from baseline to Week 48 in waist circumference [cm]

Time frame:at baseline, at week 48

Waist circumference, change

percent change from baseline, improvement

Glycemic / diabetes

2 endpoints
Secondary/protocol endpoint

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)

Time frame:at baseline, at week 48

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Secondary/protocol endpoint

Relative change from baseline to Week 48 in HOMA-IR (FPI [mlU/L] · FPG [mmol/L]/22.5)

Time frame:at baseline, at week 48

HOMA-IR (insulin sensitivity)

percent change from baseline, improvement

MASH / liver

10 endpoints
Primary/protocol endpoint

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

MRI-PDFF ≥30% responders

threshold achievement, improvement

Secondary/protocol endpoint

Absolute change from baseline to Week 48 in liver fat content assessed by MRI-PDFF [%]

Time frame:at baseline, at week 48

Liver fat content, change

change from baseline, improvement

Secondary/protocol endpoint

Relative change (%) from baseline to Week 48 in liver fat content assessed by MRI-PDFF [%]

Time frame:at baseline, at week 48

MRI-PDFF, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Reduction from baseline to Week 48 in Iron corrected T1 (cT1) [ms] levels of ≥80 ms (yes/no)

Time frame:at baseline, at week 48

threshold achievement, improvement

Secondary/protocol endpoint

Absolute change from baseline to Week 48 in alanine amino transferase (ALT) [U/L] levels

Time frame:at baseline, at week 48

ALT, change

change from baseline, improvement

LOINC 1742-6

Secondary/protocol endpoint

Relative change from baseline to Week 48 in alanine amino transferase (ALT) [U/L] levels

Time frame:at baseline, at week 48

ALT, change

percent change from baseline, improvement

LOINC 1742-6

Secondary/protocol endpoint

Absolute change from baseline to Week 48 in liver stiffness [kPa] assessed by magnetic resonance elastography (MRE)

Time frame:at baseline, at week 48

Liver stiffness (VCTE), change

change from baseline, improvement

Secondary/protocol endpoint

Relative change from baseline to Week 48 in liver stiffness [kPa] assessed by magnetic resonance elastography (MRE)

Time frame:at baseline, at week 48

percent change from baseline, improvement

Secondary/protocol endpoint

Absolute change in liver volume [mL] from baseline to Week 48 measured using MRI

Time frame:at baseline, at week 48

change from baseline, improvement

Secondary/protocol endpoint

Relative change in liver volume [mL] from baseline to Week 48 measured using MRI

Time frame:at baseline, at week 48

percent change from baseline, improvement

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.