Impaired Hepatic FunctionPhase 1NCT04823702
Study of Aldafermin (NGM282) in Participants With Impaired Hepatic Function
A Phase 1 study testing Aldafermin in people with Impaired Hepatic Function, run by NGM Biopharmaceuticals, Inc at 3 sites in United States.
Trial summary
This is an evaluation of Aldafermin (NGM282) in an open-label, single-dose and parallel group study in participants with Impaired Hepatic Function Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Impaired Hepatic Function
- What is being tested?
- Aldafermin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Apr 2021to 19 Nov 2021
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males or females, 18 - 75 years of age, inclusive
- Able to comprehend and willing to sign an informed consent form (ICF)
- Willing and able to comply with all study requirements
- BMI 18 - 40 kg/m2, inclusive at Screening
- Stable medication regimen - no medication initiation or dose change within 7 days or 5 half-lives (whichever is longer) prior to dosing of the study medication.
- Non-pregnant, non-lactating females. Female subjects of childbearing potential and male subjects with a female sexual partner of childbearing potential must agree to consistent and adequate birth control. One of the following forms of contraception is required:
Show all 15Show fewer
- Condom
- Hormone containing contraceptive
- Intrauterine device with a failure rate < 1% per year
- Cervical cap or diaphragm with spermicidal agent
- Tubal sterilization
- Vasectomy in male partner
- Sexual abstinence
- Negative test for drugs of abuse at Screening unless they are currently prescribed
- Negative human immunodeficiency virus (HIV) antibody screen at Screening
Who cannot join
- Any acute disease or condition being treated by medical therapy (prescription or over the counter) known to possibly impact hepatic function
- History of or recent (< 6 weeks) treatment for a chronic condition with a medication that is known to have hepatotoxic potential.
- Any significant physical injury or surgical procedure within 6 weeks of Screening
- Uncontrolled diabetes (hemoglobin A1c [HbA1c] > 9.5%)
- Uncontrolled hypertension (systolic blood pressure [SBP] > 180 mmHg on ≥ 3 medications of different classes for blood pressure control)
- Have received any investigational medication within 30 days or 5 half-lives, whichever is longer, prior to study dosing
Show all 10Show fewer
- Subjects should not have donated blood within 60 days of study entry or plasma within 7 days of study entry. Subjects must also refrain from blood donation from clinic admission, throughout the study period, and continuing for at least 30 days following the last dose of study medication.
- Positive urine drug screen at Screening that is not otherwise explained by a permitted concomitant medication
- History of alcoholism in the 6 months prior to Screening
- Inadequate peripheral venous access
Trial locations and contacts
3 sites in 1 country.
United States3 sites
NGM Clinical Study Site 110
Miami, Florida, 33014
NGM Clinical Study Site 111
Orlando, Florida, 32809
NGM Clinical Study Site 113
San Antonio, Texas, 78215
About this study
Official title: A Phase I, Open-label, Parallel-group Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a Single Dose of Aldafermin in Subjects With Impaired Hepatic Function
This is an evaluation of Aldafermin (NGM282) in an open-label, single-dose and parallel group study in participants with Impaired Hepatic Function
- Conditions
- Impaired Hepatic Function
- Being tested
- Aldafermin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AldaferminBiological
Also called NGM282
Biological: Aldafermin (NGM282) Subcutaneous Injection
| Study group | Role | What they receive |
|---|---|---|
| Child-Pugh A (Mild Hepatic Impairment) & Healthy Matched | Experimental | Administered by subcutaneous injection Receives: Biological: Aldafermin |
| Child-Pugh B (Moderate Hepatic Impairment) & Healthy Matched | Experimental | Administered by subcutaneous injection Receives: Biological: Aldafermin |
| Child-Pugh C (Severe Hepatic Impairment) & Healthy Matched | Experimental | Administered by subcutaneous injection Receives: Biological: Aldafermin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK) of a single dose aldafermin
Maximum observed plasma concentration (Cmax) of aldafermin (Day 1 through Day 4)
Measured: 4 days
Pharmacokinetics of a single dose of aldafermin
Area under the concentration-time curve from time zero extrapolated to infinity (AUC infinity) of aldafermin (Day 1 through Day 4)
Measured: 4 days
Secondary outcomes (1)
Type and frequency of adverse events (Day 1 through Day 11)
Frequency, severity, timing, and/or duration of treatment-emergent adverse events (TEAE) and serious adverse events (SAEs)
Measured: 11 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start1 Apr 2021
- Primary completion19 Nov 2021
- Study completion19 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impaired Hepatic FunctionStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- NGM Biopharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- NGM Study Director, Study director, NGM Biopharmaceuticals, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04823702
- Sponsor's protocol ID
- 282-HI-104
- Status last verified
- Dec 2021
- First submitted
- 26 Mar 2021
- Last updated
- 19 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label, Parallel-group Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a Single Dose of Aldafermin in Subjects With Impaired Hepatic Function
- ClinicalTrials.gov ID
- NCT04823702
- Acronym / sponsor ID
- 282-HI-104
- Conditions
- Impaired Hepatic Function
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- NGM Biopharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 19 Nov 2021 (actual)
- Study completion
- 19 Nov 2021 (actual)
- First posted
- 1 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 is an evaluation of Aldafermin (NGM282) in an open-label, single-dose and parallel group study in participants with Impaired Hepatic Function
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Child-Pugh A (Mild Hepatic Impairment) & Healthy Matched | Experimental | Biological: AldaferminAdministered by subcutaneous injection |
| Child-Pugh B (Moderate Hepatic Impairment) & Healthy Matched | Experimental | Biological: AldaferminAdministered by subcutaneous injection |
| Child-Pugh C (Severe Hepatic Impairment) & Healthy Matched | Experimental | Biological: AldaferminAdministered by subcutaneous injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Males or females, 18 - 75 years of age, inclusive
- Able to comprehend and willing to sign an informed consent form (ICF)
- Willing and able to comply with all study requirements
- BMI 18 - 40 kg/m2, inclusive at Screening
- Stable medication regimen - no medication initiation or dose change within 7 days or 5 half-lives (whichever is longer) prior to dosing of the study medication.
Key exclusion criteria (10 listed)
- Any acute disease or condition being treated by medical therapy (prescription or over the counter) known to possibly impact hepatic function
- History of or recent (< 6 weeks) treatment for a chronic condition with a medication that is known to have hepatotoxic potential.
- Any significant physical injury or surgical procedure within 6 weeks of Screening
- Uncontrolled diabetes (hemoglobin A1c [HbA1c] > 9.5%)
- Uncontrolled hypertension (systolic blood pressure [SBP] > 180 mmHg on ≥ 3 medications of different classes for blood pressure control)
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 |
|---|---|---|
| AldaferminAlso: NGM282Biological: Aldafermin (NGM282) Subcutaneous Injection | Biological | Child-Pugh A (Mild Hepatic Impairment) & Healthy Matched, Child-Pugh B (Moderate Hepatic Impairment) & Healthy Matched, Child-Pugh C (Severe Hepatic Impairment) & Healthy Matched |
Primary outcome
Pharmacokinetics (PK) of a single dose aldafermin
Time frame: 4 days
Maximum observed plasma concentration (Cmax) of aldafermin (Day 1 through Day 4)
Pharmacokinetics of a single dose of aldafermin
Time frame: 4 days
Area under the concentration-time curve from time zero extrapolated to infinity (AUC infinity) of aldafermin (Day 1 through Day 4)
1 secondary outcome
Type and frequency of adverse events (Day 1 through Day 11)
Time frame: 11 days
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 19 Jan 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Impaired Hepatic Function
RecruitingPhase 1
Pharmacokinetics of Petrelintide in Participants With Impaired Hepatic Function
Impaired Hepatic Function
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.
NGM Study Director study director
NGM Biopharmaceuticals, Inc
3 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 Aldafermin in people with Impaired Hepatic Function, run by NGM Biopharmaceuticals, Inc at 3 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 15 inclusion and 10 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 19 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Pharmacokinetics (PK) of a single dose aldafermin (time frame: 4 days). The study lists 2 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 19 Jan 2022; AzTrials last refreshed its copy on 7 Nov 2026.