AMG 609 for Non-alcoholic Fatty Liver Disease

No longer recruiting at 10 trial locations

Overseen By Amgen Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Amgen

Disqualifiers: Other liver diseases, Uncontrolled diabetes, Uncontrolled hypertension, History of malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety of a new drug, AMG 609, for individuals with non-alcoholic fatty liver disease (NAFLD), a condition characterized by fat accumulation in the liver. Participants will receive either AMG 609 or a placebo, a substance without active medication, to observe their body's reactions. Ideal candidates for this trial are those with NAFLD who have a BMI between 27 and 45 and significant liver fat. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that AMG 609 is likely to be safe for humans?

Research has shown that AMG 609, a treatment known as siRNA, has undergone safety testing in individuals with non-alcoholic fatty liver disease (NAFLD). The studies evaluated tolerance when administered as a single injection under the skin. Early results suggest that AMG 609 is generally well-tolerated. While specific side effects from these studies are not detailed, the progression of the treatment in trials indicates an acceptable safety profile. Reaching this stage of testing typically means earlier research did not identify serious safety issues. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about AMG 609 because it offers a novel approach to treating non-alcoholic fatty liver disease (NAFLD). Unlike current treatments that primarily focus on lifestyle changes or medications targeting symptoms like insulin resistance, AMG 609 works by targeting a different pathway, potentially addressing the underlying causes of the disease. This unique mechanism could offer a more direct and effective way to combat liver fat accumulation and inflammation. Additionally, the trial includes an experimental placebo group, which allows for a clearer understanding of AMG 609's effectiveness compared to no treatment at all.

What evidence suggests that AMG 609 might be an effective treatment for NAFLD?

Research has shown that AMG 609, which participants in this trial may receive, targets a specific genetic factor related to liver disease. It acts on a gene associated with fat buildup in the liver, potentially reducing liver fat and improving symptoms in individuals with non-alcoholic fatty liver disease (NAFLD). Although detailed information from human studies remains limited, early research suggests promising potential for treating this condition. The treatment is still under investigation in this trial, so further information is needed to confirm its effectiveness. ^{4 6 7 8 9}

Who Is on the Research Team?

MD

Principal Investigator

Amgen

Are You a Good Fit for This Trial?

Inclusion Criteria

Liver steatosis, measured by MRI-PDFF, greater than 8%

Your body mass index (BMI) falls between 27 and 45, inclusive.

Exclusion Criteria

You have a history of cancer, except for non-invasive cervical cancer or non-melanoma skin cancer that was removed more than 5 years ago (or 3 years ago for basal cell skin cancer).

Evidence of other liver disease (eg, viral hepatitis, primary sclerosing cholangitis, primary biliary cholangitis, autoimmune chronic hepatitis, Wilson's disease, alpha-1 anti-trypsin deficiency, haemochromatosis, drug-induced liver injury, bile duct obstruction, known or suspected hepatocellular carcinoma).

Significantly elevated LFTs (more than 1.5x ULN)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single ascending dose of AMG 609 or placebo subcutaneously

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and tolerability after receiving the dose

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• AMG 609

How Is the Trial Designed?

Group I: Placebo Experimental Treatment 1 Intervention

Participants will receive the matching placebo.

Group II: AMG 609 Experimental Treatment 1 Intervention

Up to 7 cohorts ranging by various dose levels.

Who Is Running the Clinical Trial?

Amgen

Lead Sponsor

Trials

1,508

Recruited

1,433,000+

Founded

1980

Headquarters

Thousand Oaks, USA

Known For

Human Therapeutics

Top Products

Enbrel, Prolia, Neulasta, Otezla

Robert A. Bradway

Amgen

Chief Executive Officer since 2012

MBA from Harvard Business School

Paul Burton

Amgen

Chief Medical Officer since 2023

MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London

Citations

1. clinicaltrialsarena.com clinicaltrialsarena.com/features/pipeline-moves-adavancement-prospects-plunge-for-oesophageal-adenocarcinoma-therapy/

Pipeline Moves: Advancement prospects plunge for ... Amgen's AMG-609 saw its PTSR increase in non-alcoholic fatty liver disease (NAFLD) after the completion of a Phase I trial. The drug's PTSR grew ...

2. annalsofoncology.org annalsofoncology.org/article/S0923-7534(20)40865-8/fulltext

609O Results from a phase I study of AMG 160, a half-life ... PSA reductions occurred in 15/24 (63%) evaluable pts; reductions >50% occurred in 6/10 (60%) pts at DL5 and DL6. Overall, 6/22 (27%) pts had confirmed PSA ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11907219/

Targeting PNPLA3 to Treat MASH and MASH Related ... AMG 609 is a PNPLA3 148M allele selective GalNac siRNA [50] that has been evaluated in a SAD trial in patients with MASLD. However, AMG 609 is no longer ...

4. investors.amgen.com investors.amgen.com/news-releases/news-release-details/landmark-phase-3-trial-vesalius-cv-meets-primary-endpoints

LANDMARK PHASE 3 TRIAL (VESALIUS-CV) MEETS ... The results show that the primary endpoints were both statistically and clinically significant. No new safety signals were observed. "These ...

5. novartis.com novartis.com/news/media-releases/novartis-presents-new-data-demonstrating-long-term-efficacy-safety-and-tolerability-aimovig-erenumab-patients-chronic-and-episodic-migraine

Novartis presents new data demonstrating long-term ... Of the 609 patients who enrolled in the study, 199 increased their dose from 70 mg to 140 mg by week 28[1]. The primary outcome measure of the study was long- ...

6. adisinsight.springer.com adisinsight.springer.com/drugs/800063496

AMG 609 - AdisInsight - Springer AMG 609 is siRNA (small interfering RNA) small molecule that selectively targets a variant allele of patatin like phospholipase domain containing 3, ...

7. synapse.patsnap.com synapse.patsnap.com/drug/08c89b5c265d4ebdba690ea8cfd8d461

AMG-609 - Drug Targets, Indications, Patents ... Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 609 in Subjects With Non-alcoholic Fatty Liver Disease. 100 Clinical Results associated ...

8. ctv.veeva.com ctv.veeva.com/study/single-ascending-dose-of-amg-609-in-participants-with-non-alcoholic-fatty-liver-disease

Single Ascending Dose of AMG 609 in Participants With Non ... This study aims to assess the safety and tolerability of AMG 609 when administered subcutaneously as single doses in participants with non ...

9. amgen.com amgen.com/products/safety-data-sheets

Safety Data Sheets To the best of our knowledge, the information provided in each SDS is accurate, and based on data available to Amgen, as of the date of the Safety Data Sheet.