What is the mechanism of action of this treatment?

Common treatments for Non-alcoholic Fatty Liver Disease (NAFLD) often involve GLP-1 receptor agonists and dual agonists like efinopegdutide. These treatments work by enhancing insulin secretion, inhibiting glucagon release, and slowing gastric emptying, which improve glycemic control and promote weight loss. Dual agonists also activate the glucagon receptor, enhancing energy expenditure and reducing liver fat. These mechanisms are crucial for NAFLD patients as they address underlying metabolic dysfunctions, potentially reversing liver steatosis and preventing progression to more severe liver disease.

What side effects are associated with this type of intervention?

Common treatments for Non-alcoholic Fatty Liver Disease (NAFLD) similar to Efinopegdutide, such as GLP-1 receptor agonists, include medications like liraglutide and semaglutide. The known side effects of these treatments often include gastrointestinal symptoms such as nausea, vomiting, and diarrhea. Additionally, there is a potential risk of acute pancreatitis and, in rare cases, pancreatic cancer. Other side effects may include injection site reactions and, less commonly, gallbladder-related issues such as cholelithiasis.

What prior FDA approvals exist?

The FDA has approved several GLP-1 receptor agonists for the treatment of type 2 diabetes, which have also shown efficacy in treating Non-alcoholic Fatty Liver Disease (NAFLD) and Non-alcoholic Steatohepatitis (NASH). Liraglutide, a GLP-1 receptor agonist, has demonstrated improvement in liver function tests and histology in patients with NASH. Other GLP-1 receptor agonists like exenatide have also shown similar benefits. These drugs, while primarily approved for diabetes, have been beneficial in managing liver-related conditions due to their effects on weight loss and glycemic control.

What other types of research exist?

Promising alternatives to Efinopegdutide for NAFLD patients include: 1) SGLT-2 inhibitors like Ipragliflozin, which have shown effectiveness in patients with Type 2 Diabetes Mellitus (T2DM) and NAFLD. 2) GLP-1 receptor agonists such as Liraglutide and Semaglutide, which have demonstrated benefits in reducing liver steatosis and improving glycemic control. 3) DPP-4 inhibitors like Linagliptin, which have shown positive effects on liver enzymes and steatosis in NAFLD patients with T2DM.

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Glucagon-like peptide-1 (GLP-1) receptor agonist

Efinopegdutide for Nonalcoholic Steatohepatitis (NASH)

Verified Trial

Phase 2

Recruiting

Research Sponsored by Merck Sharp & Dohme LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Do you have NASH?

Be older than 18 years old

Must not have

Have you ever had a liver disease other than NASH?

Do you have uncontrolled type II diabetes?

Timeline

Screening 10 weeks

Treatment 12 months

Follow Up 9 weeks

Summary

This trial is testing a new medicine called efinopegdutide to see if it can help people with a liver disease called non-alcoholic steatohepatitis (NASH). Researchers want to find out if this medicine can reduce the symptoms of NASH without making liver scarring worse. They are also checking how safe the medicine is and how well people can tolerate it.

Who is the study for?

This trial is for individuals with NASH, a type of liver disease where fat builds up in the liver. Participants should not have other types of liver diseases, uncontrolled Type II diabetes, or a history of cirrhosis or pancreatitis. Those who've had bariatric surgery within the last 5 years are also excluded.

What is being tested?

The study tests how effective Efinopegdutide is compared to a placebo in treating NASH. It aims to see if Efinopegdutide can reduce signs of NASH without worsening liver scarring. Semaglutide's effects may also be observed as part of the study.

What are the potential side effects?

While specific side effects aren't listed here, common reactions to drugs like Efinopegdutide could include gastrointestinal issues (nausea, vomiting), injection site reactions, and potential changes in blood sugar levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have NASH.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have not had liver diseases other than NASH.

Select...

My type II diabetes is not under control.

Select...

I have not had bariatric surgery in the last 5 years.

Select...

I have never had cirrhosis or pancreatitis.

Timeline

Screening ~ 10 weeks3 visits

Treatment ~ 12 months10 visits

Follow Up ~ 9 weeks1 visit

Screening ~ 10 weeks

Treatment ~ 12 months

Follow Up ~9 weeks

This trial's timeline: 10 weeks for screening, 12 months for treatment, and 9 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Participants Discontinuing Study Medication Due to an AE

Percentage of Participants Who Experienced an Adverse Event (AE)

Percentage of Participants With Nonalcoholic Steatohepatitis (NASH) Resolution Without Worsening of Fibrosis At Week 52

Secondary study objectives

Change from Baseline in Body Weight At Week 52

Percentage of Participants With ≥1 Stage Improvement in Fibrosis Without Worsening of Steatohepatitis At Week 52

Side effects data

From 2018 Phase 3 trial • 458 Patients • NCT03015220

26%

Nasopharyngitis

Constipation

Influenza

Diabetic retinopathy

Nausea

Gastrooesophageal reflux disease

Back pain

Upper respiratory tract inflammation

Abdominal discomfort

Vomiting

Diarrhoea

Cardiac ablation

Herpes zoster

Ischaemic cerebral infarction

Acute myocardial infarction

Appendicitis

Large intestine polyp

Peritonitis

Sudden hearing loss

Rectal adenocarcinoma

Spinal operation

100%

80%

60%

40%

20%

Study treatment Arm

Oral Semaglutide 3 mg

Oral Semaglutide 7 mg

Oral Semaglutide 14 mg

Dulaglutide 0.75 mg

Trial Design

5Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Efinopegdutide 7mgExperimental Treatment1 Intervention

Efinopegdutide administered by SC injection once weekly for 52 weeks in a dose-escalation regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, and 7 mg for 44 weeks.

Group II: Efinopegdutide 4mgExperimental Treatment1 Intervention

Efinopegdutide administered by subcutaneous (SC) injection once weekly for 52 weeks in a dose-escalation regimen of 2 mg for 4 weeks and 4mg for 48 weeks.

Group III: Efinopegdutide 10mgExperimental Treatment1 Intervention

Efinopegdutide administered by SC injection once weekly for 52 weeks in a dose-escalation regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, and 10 mg for 40 weeks.

Group IV: Semaglutide 2.4 mgActive Control1 Intervention

Semaglutide administered by SC injection once weekly for 52 weeks in a dose-escalation regimen of 0.25 mg for 4 weeks, 0.5 mg for 4 weeks, 1.0 mg for 4 weeks, 1.7 mg for 4 weeks, and 2.4 mg for 36 weeks.

Group V: PlaceboPlacebo Group1 Intervention

Placebo administered by SC injection once weekly for 52 weeks

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Non-alcoholic Fatty Liver Disease (NAFLD) often involve GLP-1 receptor agonists and dual agonists like efinopegdutide. These treatments work by enhancing insulin secretion, inhibiting glucagon release, and slowing gastric emptying, which improve glycemic control and promote weight loss. Dual agonists also activate the glucagon receptor, enhancing energy expenditure and reducing liver fat. These mechanisms are crucial for NAFLD patients as they address underlying metabolic dysfunctions, potentially reversing liver steatosis and preventing progression to more severe liver disease.