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New treatment option for Non-alcoholic Fatty Liver Disease
Official title A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
ClinicalTrials.gov ID: NCT07358546
What this study is testing
What is Efimosfermin alfa?
Efimosfermin alfa is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for non-alcoholic fatty liver disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is designed to study the pharmacokinetic (PK) and safety profiles of a single dose of efimosfermin alfa in participants with varying degrees of Hepatic Impairment (HI) (assessed by Child-Pugh score) due to steatotic liver disease, with and without significant alcohol consumption.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Between 18 years and 70 years of age inclusive
- Body Mass Index (BMI) within the range 23-40 kilogram per square meter (kg/m\^2)
- Male or female participants
- Participant has liver cirrhosis with a grade of hepatic impairment that can be classified as a discrete Child-Pugh class. Participants must:
- Have a clinical diagnosis of liver cirrhosis in the participant's medical history corroborated by previous liver biopsy, medical imaging or...
You likely can't join if
- History of extrahepatic disorders possibly related to etiology of cirrhosis.
- History of cryoglobulinemia.
- Participants with Grade 3 ascites or refractory ascites.
- Participants with refractory encephalopathy or significant central nervous system disease
- History of gastric or esophageal variceal bleeding within the past 6 months and for which varices have not been adequately treated with medication...
- Other primary causes of liver disease. Steatotic liver disease must be the primary cause of liver disease.
See the full eligibility criteria
- Between 18 years and 70 years of age inclusive
- Body Mass Index (BMI) within the range 23-40 kilogram per square meter (kg/m\^2)
- Male or female participants
- Participant has liver cirrhosis with a grade of hepatic impairment that can be classified as a discrete Child-Pugh class. Participants must:
- Have a clinical diagnosis of liver cirrhosis in the participant's medical history corroborated by previous liver biopsy, medical imaging or compatible biochemical profile, and
- Be classed during Screening as one of the following Child-Pugh classes:
- Child-Pugh B: Score 7-9 or
- Child-Pugh C: Score 10-15
- Chronic (greater than [\>] 6 months) HI which is currently stable (no acute episodes of illness within the previous 1 month prior to Screening (Visit 1) due to deterioration in hepatic function). Participants must also...
- History of extrahepatic disorders possibly related to etiology of cirrhosis.
- History of cryoglobulinemia.
- Participants with Grade 3 ascites or refractory ascites.
- Participants with refractory encephalopathy or significant central nervous system disease
- History of gastric or esophageal variceal bleeding within the past 6 months and for which varices have not been adequately treated with medication and/or surgical procedures.
- Other primary causes of liver disease. Steatotic liver disease must be the primary cause of liver disease.
- Clinically significant abnormalities affecting physical health in medical history, or on physical examination, that could interfere with or for which treatment could interfere with the conduct of the study, or that...
- Current, or history of known hepatocellular carcinoma (HCC).
- Participants with transjugular intrahepatic portosystemic shunt (TIPS) placement.
- Presence of hepatopulmonary or hepatorenal syndrome.
- Presence of primarily cholestatic liver diseases.
- Evidence of symptomatic or complicated cholecystitis.
- History of pancreatic injury, pancreatitis, or other pancreatic disease.
- History of liver transplantation, or active on the liver transplant waiting list.
- Participants with signs of active infection
- History of adrenal gland disease or using treatment that affects the hypothalamic-pituitary-adrenal axis.
- History of significant bone disease such as osteoporosis
- Psychosocial features that, in the opinion of the investigator, increase the likelihood of loss to follow-up.
- History or presence of drug abuse.
- Use of other investigational drugs at the time of screening, or within 5 half-lives or 30 days prior to study intervention, whichever was longer; or longer if required by local regulations
- Have previously taken efimosfermin alfa
- Participants with Alanine Aminotransferase (ALT) value \>3 times (x) upper limit of normal (ULN)
- Participants with Aspartate aminotransferase (AST) value \>=300 Units/Liter.
- Participants with estimated glomerular filtration rate (eGFR) (Chronic Kidney Disease Epidemiology [CKD-Epi] 2021) \<45 milliliter/minute/1.73 square meter (mL/min/1.73m\^2).
- Average of triplicate QT interval corrected for heart rate using Fridericia formula (QTcF) \>480 milliseconds (msec) (for male and female participants) at Screening
- For participants in the MASH with alcohol category, significant risk of withdrawal symptoms.
The study team makes the final eligibility decision.
Where it's taking place
- Rialto, California, United States
- Tampa, Florida, United States
- San Antonio, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rialto, California, United States; Tampa, Florida, United States; San Antonio, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.