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ObesityPhase 3NCT06309992

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)

A Phase 3 study testing Survodutide in people with Obesity and Non-Alcoholic SteatoHepatitis (NASH), run by Boehringer Ingelheim at 37 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obesity, Non-Alcoholic SteatoHepatitis (NASH)
What is being tested?
Survodutide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
218 participants
Where
37 sitesin 2 countries
Study dates
2 Apr 2024to 2 Dec 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to 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 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.

Who cannot join

  • 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.

Trial locations and contacts

37 sites in 2 countries.

37 sites in 2 countries

United States33 sites

  • Velocity Clinical Research, Austin

    Austin, Texas, 78759

  • Excel Medical Clinical Trials

    Boca Raton, Florida, 33434

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • DSI Research Northridge LLC

    Dayton, Ohio, 45414

  • Segal Drug Trials

    Delray Beach, Florida, 33484

  • Fleming Island Center for Clinical Research

    Fleming Island, Florida, 32003

  • Covenant Metabolic Specialists, LLC - Fort Myers

    Fort Myers, Florida, 33912

  • ARK Clinical Research

    Fountain Valley, California, 92708

  • Velocity Clinical Research-Gardena-69773

    Gardena, California, 90247

  • Amel Med LLC

    Georgetown, Texas, 78628

  • Velocity Clinical Research-Hallandale Beach-67888

    Hallandale, Florida, 33009

  • Gastroenterology and Liver Research LLC

    Houston, Texas, 77043

  • Biopharma Informatic, Inc. Research Center

    Houston, Texas, 77084

  • Accurate Clinical Research, Inc.

    Humble, Texas, 77346

  • Indiana University

    Indianapolis, Indiana, 46202

  • Nature Coast Clinical Research-Inverness-48221

    Inverness, Florida, 34452

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • Health Awareness, Inc.

    Jupiter, Florida, 33458

  • ARK Clinical Research

    Long Beach, California, 92657

  • Verus Clinical Research Corporation

    Miami, Florida, 33135

  • Panax Clinical Research

    Miami Lakes, Florida, 33014

  • Catalina Research Institute, LLC

    Montclair, California, 91763

  • Velocity Clinical Research-North Hollywood-69852

    North Hollywood, California, 91606

  • Velocity Clinical Research-Panorama City-68861

    Panorama City, California, 91402

  • GI Select Health Research LLC

    Richmond, Virginia, 23236

  • Clinical Trials of Texas, LLC

    San Antonio, Texas, 78229

  • Velocity Clinical Research, Santa Ana

    Santa Ana, California, 92704

  • Covenant Research and Clinics, LLC

    Sarasota, Florida, 34240

  • Louisiana Research Center, LLC

    Shreveport, Louisiana, 71105

  • Springfield Clinic, LLP

    Springfield, Illinois, 62702

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Kansas Medical Clinic PA

    Topeka, Kansas, 66606-1707

  • Velocity Clinical Research, Waco

    Waco, Texas, 76710

Other trials in United States

Spain4 sites

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Clínic de Barcelona

    Barcelona, 08036

  • Hospital Universitario Ramon Y Cajal

    Madrid, 28034

  • Hospital Universitario La Paz

    Madrid, 28046

Other trials in Spain

About this study

Official title: 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)

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.
Read more

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.

Being tested
Survodutide, Placebo
Medical subject headings
Obesity, Non-alcoholic Fatty Liver Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SurvodutideCombination product

    Survodutide, pre-filled syringe

  • PlaceboCombination product

    Placebo matching survodutide, pre-filled syringe

Study groups in NCT06309992
Study groupRoleWhat they receive
Treatment armExperimentalNot described
Receives: Combination Product: Survodutide
Placebo armPlacebo comparatorNot described
Receives: Combination Product: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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) [%]

    Measured: at baseline, at week 48

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

    Measured: at baseline, at week 48

Secondary outcomes (13)

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

    Measured: at baseline, at week 48

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

    Measured: at baseline, at week 48

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

    Measured: at baseline, at week 48

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

    Measured: at baseline, at week 48

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

    Measured: at baseline, at week 48

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

    Measured: at baseline, at week 48

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

    Measured: at baseline, at week 48

  8. 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)

    Measured: at baseline, at week 48

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

    Measured: at baseline, at week 48

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

    Measured: at baseline, at week 48

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

    Measured: at baseline, at week 48

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

    Measured: at baseline, at week 48

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

    Measured: at baseline, at week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2024
  2. Study start2 Apr 2024
  3. Primary completion9 Oct 2025
  4. Study completion2 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
218 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06309992
Sponsor's protocol ID
1404-0056
Other IDs
2023-505303-23-00, U1111-1299-9925, 2023
Status last verified
Apr 2026
First submitted
8 Mar 2024
Last updated
30 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

Publications

  • Younossi ZM, Razavi H, Sherman M, Allen AM, Anstee QM, Cusi K, Friedman SL, Lawitz E, Lazarus JV, Schuppan D, Romero-Gomez M, Schattenberg JM, Vos MB, Wong VW, Ratziu V, Hompesch M, Sanyal AJ, Loomba R. Addressing the High and Rising Global Burden of Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) and Metabolic Dysfunction-Associated Steatohepatitis (MASH): From the Growing Prevalence to Payors' Perspective. Aliment Pharmacol Ther. 2025 May;61(9):1467-1478. doi: 10.1111/apt.70020. Epub 2025 Feb 18.

    PubMed 39967239

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Survodutide in people with Obesity and Non-Alcoholic SteatoHepatitis (NASH), run by Boehringer Ingelheim at 37 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in United States, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06309992, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.

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