Non-alcoholic Fatty Liver DiseasePhase 1NCT04857606
Single Ascending Dose of AMG 609 in Participants With Non-alcoholic Fatty Liver Disease
A Phase 1 study testing AMG 609 in people with Non-alcoholic Fatty Liver Disease, run by Amgen at 10 sites in United States.
Trial summary
This study aims to assess the safety and tolerability of AMG 609 when administered subcutaneously as single doses in participants with non-alcoholic fatty liver disease (NAFLD). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Non-alcoholic Fatty Liver Disease
- What is being tested?
- AMG 609
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 10 sitesUnited States
- Study dates
- 24 May 2021to 19 Jul 2023
- Phase
- Phase 1
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women age ≥ 18 to ≤ 70 years of age at the time of signing the informed consent
- Body mass index (BMI) of ≥ 27 kg/m2 to ≤ 45.0 kg/m2
- Liver steatosis, measured by MRI-PDFF, greater than 8%
Who cannot join
- 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)
- Uncontrolled diabetes (HgbA1c > 9%) or uncontrolled hypertension.
- History of malignancy of any type, other than in situ cervical cancer or surgically excised non-melanomatous skin cancers occurring more than 5 years prior to randomization or 3 years prior to randomization for basal cell carcinoma.
- Females of reproductive potential.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Translational Clinical Research LLC
Aventura, Florida, 33180
The Institute for Liver Health - Arizona Liver Health
Chandler, Arizona, 85224
ProSciento Incorporated
Chula Vista, California, 91911
Catalina Research Institute
Montclair, California, 91763
Inland Empire Liver Foundation
Rialto, California, 92377
McGuire VA Medical Center
Richmond, Virginia, 23249
Texas Liver Institute
San Antonio, Texas, 78215
Endeavor Clinical Trials
San Antonio, Texas, 78229
Pinnacle Clinical Research
San Antonio, Texas, 78229
Orange County Research Center
Tustin, California, 92780
About this study
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 609 in Subjects With Non-alcoholic Fatty Liver Disease
This study aims to assess the safety and tolerability of AMG 609 when administered subcutaneously as single doses in participants with non-alcoholic fatty liver disease (NAFLD).
- Conditions
- Non-alcoholic Fatty Liver Disease
- Being tested
- AMG 609, Placebo
- Keywords
- Single ascending dose, NAFLD, AMG 609
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMG 609Drug
Single dose of AMG 609 administered as a subcutaneous injection.
PlaceboDrug
Single dose of placebo administered as a subcutaneous injection.
| Study group | Role | What they receive |
|---|---|---|
| AMG 609 | Experimental | Up to 7 cohorts ranging by various dose levels. Receives: Drug: AMG 609 |
| Placebo | Experimental | Participants will receive the matching placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject Incidence of Treatment-emergent Adverse Events
Measured: Day 1 to Day 150
Subject Incidence of Clinically Significant Change from Baseline in Laboratory Analytes
Measured: Baseline to Day 150
Subject Incidence of Clinically Significant Change from Baseline in Vital Signs
Measured: Baseline to Day 150
Subject Incidence of Clinically Significant Change from Baseline in 12-lead Electrocardiograms (ECGs)
Measured: Baseline to Day 113
Secondary outcomes (3)
Maximum Observed Concentration (Cmax) of AMG 609
Measured: Up to Day 150
Time to Maximum Observed Concentration (Tmax) of AMG 609
Measured: Up to Day 150
Area Under the Concentration Time Curve (AUC) of AMG 609
Measured: Up to Day 150
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2021
- Study start24 May 2021
- Primary completion19 Jul 2023
- Study completion19 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04857606
- Sponsor's protocol ID
- 20200001
- Status last verified
- Nov 2023
- First submitted
- 21 Apr 2021
- Last updated
- 7 Nov 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 609 in Subjects With Non-alcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT04857606
- Acronym / sponsor ID
- 20200001
- Conditions
- Non-alcoholic Fatty Liver Disease
- Keywords
- Single ascending dose, NAFLD, AMG 609
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 24 May 2021 (actual)
- Primary completion
- 19 Jul 2023 (actual)
- Study completion
- 19 Jul 2023 (actual)
- First posted
- 23 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to assess the safety and tolerability of AMG 609 when administered subcutaneously as single doses in participants with non-alcoholic fatty liver disease (NAFLD).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AMG 609 | Experimental | Drug: AMG 609Up to 7 cohorts ranging by various dose levels. |
| Placebo | Experimental | Drug: PlaceboParticipants will receive the matching placebo. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
Key exclusion criteria (5 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMG 609Single dose of AMG 609 administered as a subcutaneous injection. | Drug | AMG 609 |
| PlaceboSingle dose of placebo administered as a subcutaneous injection. | Drug | Placebo |
Primary outcome
Subject Incidence of Treatment-emergent Adverse Events
Time frame: Day 1 to Day 150
Subject Incidence of Clinically Significant Change from Baseline in Laboratory Analytes
Time frame: Baseline to Day 150
Subject Incidence of Clinically Significant Change from Baseline in Vital Signs
Time frame: Baseline to Day 150
Subject Incidence of Clinically Significant Change from Baseline in 12-lead Electrocardiograms (ECGs)
Time frame: Baseline to Day 113
3 secondary outcomes
Maximum Observed Concentration (Cmax) of AMG 609
Time frame: Up to Day 150
Time to Maximum Observed Concentration (Tmax) of AMG 609
Time frame: Up to Day 150
Area Under the Concentration Time Curve (AUC) of AMG 609
Time frame: Up to Day 150
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AMG 609 in people with Non-alcoholic Fatty Liver Disease, run by Amgen at 10 sites in United States.
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 3 inclusion and 5 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 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Subject Incidence of Treatment-emergent Adverse Events (time frame: Day 1 to Day 150). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Nov 2023.