Survodutide for Fatty Liver Disease

Not yet recruiting at 33 trial locations
BI
Overseen ByBoehringer Ingelheim
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a new medicine, survodutide, can help people with a type of fatty liver disease known as MASLD. The researchers aim to determine if survodutide can improve heart health in individuals with this liver condition. Participants will receive either survodutide or a placebo, which resembles the medicine but contains no active ingredients. This trial suits adults with a BMI of 27 or higher and specific heart and blood vessel risk factors. Participants will engage for up to 1.5 years, with regular check-ups, including heart scans using ultrasound. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have taken medications for obesity within 3 months before the trial.

Is there any evidence suggesting that survodutide is likely to be safe for humans?

Research has shown that survodutide has been tested in individuals with liver conditions similar to those in the current study. In one study, more than 92% of participants taking survodutide experienced side effects. However, these side effects were expected, and the treatment was generally considered safe. Another study found that side effects appeared in 25% of healthy individuals and up to 87.5% of those with liver cirrhosis after just one dose of survodutide.

These findings suggest that while survodutide is associated with side effects, they are usually manageable. Participants should be aware of this and discuss any concerns with their healthcare team during the trial.12345

Why do researchers think this study treatment might be promising for fatty liver disease?

Survodutide is unique because it targets fatty liver disease through a potentially novel mechanism of action. Unlike current treatments like lifestyle changes, vitamin E, or pioglitazone, which focus on managing symptoms or improving insulin sensitivity, Survodutide may work by directly reducing liver fat content. Researchers are excited about this treatment because it offers a more targeted approach, possibly leading to better outcomes for patients with fewer side effects.

What evidence suggests that survodutide might be an effective treatment for fatty liver disease?

Research has shown that survodutide, which participants in this trial may receive, might help treat fatty liver disease by affecting the body's metabolism. In early studies, patients showed reduced liver fat and improved metabolic health, often indicating a healthier liver. Survodutide also aims to assist with weight loss and blood sugar control, crucial for liver health issues related to metabolism. Although long-term effects remain under investigation, early results suggest potential benefits for heart and liver health. More studies, including this trial, are underway to confirm these benefits in larger populations.678910

Are You a Good Fit for This Trial?

This trial is for adults 18 or older with fatty liver disease (MASLD), a BMI of 27 or higher, and certain heart or blood vessel risk factors. People who meet these criteria may be able to join.

Inclusion Criteria

Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
Body mass index (BMI) ≥27 kg/m²
I am at least 18 years old or the legal age of consent in my country.
See 1 more

Exclusion Criteria

I have taken obesity medications in the past 3 months.
Known or suspected hypersensitivity to the investigational medicinal product (IMP) or related products
I have kidney problems or need dialysis.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive weekly injections of survodutide or placebo for up to 76 weeks

76 weeks
14 visits (in-person), 4 phone calls

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Survodutide

Trial Overview

The study tests if survodutide injections can improve heart structure and function in people with MASLD compared to placebo. Participants are randomly assigned to receive either survodutide or placebo once a week for up to 1.5 years, without knowing which one they get.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Survodutide armExperimental Treatment1 Intervention
Group II: Placebo armPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead Sponsor

Trials
2,566
Recruited
16,150,000+

Citations

Effectiveness

Effectiveness or effectivity is the capability of producing a desired result or the ability to produce desired output. When something is deemed effective, ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/24330006/

Effectiveness and safety of novel oral anticoagulants as ...

NOACs have comparable efficacy to that of VKAs, and are associated with a significantly lower risk of bleeding complications, although the NNT to prevent

3.

homvee.acf.gov

homvee.acf.gov/home

What is Home Visiting Evidence of Effectiveness? | Home ...

This video explains how HomVEE reviews research, rates model effectiveness, and determines which models meet criteria for evidence of effectiveness.

Institutional Effectiveness Partnership Initiative

IEPI advances effective practices that strengthen institutional effectiveness and improve student success. Data Guided Pathways

Evaluation Criteria

The OECD has defined six evaluation criteria – relevance, coherence, effectiveness, efficiency, impact and sustainability – and two principles for their use.

SYNCHRONIZE-MASLD, a randomized, double-blind ...

The present study was conducted in participants with obesity and what we have defined as at-risk MASLD, as determined by liver steatosis in the ...

Survodutide US FDA Breakthrough Therapy phase 3 trials ...

Boehringer receives U.S. FDA Breakthrough Therapy designation and initiates two phase III trials in MASH for survodutide.

SURVODUTIDE REDUCES LIVER FAT CONTENT ...

Any adverse events (AEs) occurred in 92.3% of participants across all survodutide groups, No unexpected safety issues were reported. Conclusion ...

NCT06309992 | A Study to Test Whether Survodutide ...

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 ...

10.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38847460/

A Phase 2 Randomized Trial of Survodutide in MASH and ...

A decrease in liver fat content by at least 30% occurred in 63% of the participants in the survodutide 2.4-mg group,