NASH - Nonalcoholic SteatohepatitisPhase 1NCT05090111
A Study of ALG-055009 in Healthy Volunteers and Subjects With Hyperlipidemia
A Phase 1 study testing ALG-055009 in people with NASH - Nonalcoholic Steatohepatitis, run by Aligos Therapeutics at 1 site in France.
Trial summary
A Randomized Study of ALG-055009 Drug to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses in Healthy Volunteers and Subjects with Hyperlipidemia Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- NASH - Nonalcoholic Steatohepatitis
- What is being tested?
- ALG-055009
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2021to 16 Jun 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and Female between 18 and 55 years old
- BMI 18.0 to 32.0 kg/m^2
- Male and Female between 18 and 65 years old
- BMI 18.0 to 35.0 kg/m^2
- Subject must be on a stable diet for the 3 months prior to screening with a fasting LDL-C level >110 mg/dL at screening
Who cannot join
- Subjects with any current or previous illness that, in the opinion of the Investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject or that could prevent, limit, or confound the protocol specified assessments or study results' interpretation
- Subjects with Hepatitis A, B, C or HIV-1/HIV-2 infection or acute infections such as SARS- CoV-2 infection
- Subjects with renal dysfunction (e.g., estimated creatinine clearance <90 mL/min/1.73 m^2 at screening, calculated by the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula)
- Subjects with history of thyroid disorder or abnormal thyroid function tests at screening or known sensitivity to thyroid medications
- Subjects receiving, or urgently requiring, any lipid lowering therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Double-blind, Randomized, Placebo-controlled, First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Oral Doses of ALG-055009 in Healthy Volunteers and Subjects With Hyperlipidemia, and an Open-Label Assessment of Bioavailability and Food-effect in Healthy Volunteers
A Randomized Study of ALG-055009 Drug to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses in Healthy Volunteers and Subjects with Hyperlipidemia
- Conditions
- NASH - Nonalcoholic Steatohepatitis
- Being tested
- ALG-055009, Placebo
- 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.
ALG-055009Drug
Single or multiple doses of ALG-055009
PlaceboDrug
Single or multiple doses of Placebo
| Study group | Role | What they receive |
|---|---|---|
| ALG-055009 | Experimental | Oral dose(s) of ALG-055009 in Healthy Volunteer or subjects with mild hyperlipidemia once daily up to 14 days Receives: Drug: ALG-055009 |
| Placebo | Placebo comparator | Oral dose(s) of placebo in Healthy Volunteer or subjects with mild hyperlipidemia once daily up to 14 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1
Measured: Up to 14 days for Part 1
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1
Measured: Up to 28 days for Part 2
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1
Measured: Up to 35 days for Part 3
Secondary outcomes (6)
Maximum Plasma Concentration [Cmax]
Pharmacokinetic parameters of ALG-055009 in plasma
Measured: Predose (between -0.25 hours and 0 hours) up to 35 Days
Area under the concentration time curve [AUC]
Pharmacokinetic parameters of ALG-055009 in plasma
Measured: Predose (between -0.25 hours and 0 hours) up to 35 Days
Time to maximum plasma concentration [Tmax]
Pharmacokinetic parameters of ALG-055009 in plasma
Measured: Predose (between -0.25 hours and 0 hours) up to 35 Days
Half-life [t1/2]
Pharmacokinetic parameters of ALG-055009 in plasma
Measured: Predose (between -0.25 hours and 0 hours) up to 35 Days
Minimum Plasma Concentration [Cmin]
Pharmacokinetic parameters of ALG-055009 in plasma
Measured: Predose (between -0.25 hours and 0 hours) up to 35 Days
Change in lipid / lipoprotein levels from baseline through Day 28 in Multiple Dose in Subjects with Mild Hyperlipidemia
Measured: Screening, Day -1 to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study start1 Dec 2021
- Primary completion16 Jun 2023
- Study completion16 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NASH - Nonalcoholic SteatohepatitisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aligos Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05090111
- Sponsor's protocol ID
- ALG-055009-301
- Status last verified
- Sep 2023
- First submitted
- 11 Oct 2021
- Last updated
- 25 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Double-blind, Randomized, Placebo-controlled, First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Oral Doses of ALG-055009 in Healthy Volunteers and Subjects With Hyperlipidemia, and an Open-Label Assessment of Bioavailability and Food-effect in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05090111
- Acronym / sponsor ID
- ALG-055009-301
- Conditions
- NASH - Nonalcoholic Steatohepatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Aligos TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 16 Jun 2023 (actual)
- Study completion
- 16 Jun 2023 (actual)
- First posted
- 22 Oct 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.
A Randomized Study of ALG-055009 Drug to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses in Healthy Volunteers and Subjects with Hyperlipidemia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALG-055009 | Experimental | Drug: ALG-055009Oral dose(s) of ALG-055009 in Healthy Volunteer or subjects with mild hyperlipidemia once daily up to 14 days |
| Placebo | Placebo comparator | Drug: PlaceboOral dose(s) of placebo in Healthy Volunteer or subjects with mild hyperlipidemia once daily up to 14 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and Female between 18 and 55 years old
- BMI 18.0 to 32.0 kg/m^2
- Male and Female between 18 and 65 years old
- BMI 18.0 to 35.0 kg/m^2
- Subject must be on a stable diet for the 3 months prior to screening with a fasting LDL-C level >110 mg/dL at screening
Key exclusion criteria (5 listed)
- Subjects with any current or previous illness that, in the opinion of the Investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject or that could prevent, limit, or confound the protocol specified assessments or study results' interpretation
- Subjects with Hepatitis A, B, C or HIV-1/HIV-2 infection or acute infections such as SARS- CoV-2 infection
- Subjects with renal dysfunction (e.g., estimated creatinine clearance <90 mL/min/1.73 m^2 at screening, calculated by the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula)
- Subjects with history of thyroid disorder or abnormal thyroid function tests at screening or known sensitivity to thyroid medications
- Subjects receiving, or urgently requiring, any lipid lowering therapy
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 |
|---|---|---|
| ALG-055009Single or multiple doses of ALG-055009 | Drug | ALG-055009 |
| PlaceboSingle or multiple doses of Placebo | Drug | Placebo |
Primary outcome
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: Up to 14 days for Part 1
The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: Up to 28 days for Part 2
The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: Up to 35 days for Part 3
The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1
6 secondary outcomes
Maximum Plasma Concentration [Cmax]
Time frame: Predose (between -0.25 hours and 0 hours) up to 35 Days
Area under the concentration time curve [AUC]
Time frame: Predose (between -0.25 hours and 0 hours) up to 35 Days
Time to maximum plasma concentration [Tmax]
Time frame: Predose (between -0.25 hours and 0 hours) up to 35 Days
Half-life [t1/2]
Time frame: Predose (between -0.25 hours and 0 hours) up to 35 Days
Minimum Plasma Concentration [Cmin]
Time frame: Predose (between -0.25 hours and 0 hours) up to 35 Days
Change in lipid / lipoprotein levels from baseline through Day 28 in Multiple Dose in Subjects with Mild Hyperlipidemia
Time frame: Screening, Day -1 to Day 28
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 25 Sep 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ALG-055009 in people with NASH - Nonalcoholic Steatohepatitis, run by Aligos Therapeutics at 1 site in France.
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 5 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 25 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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. Some participants in this study may receive a placebo. 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?
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (time frame: Up to 14 days for Part 1). The study lists 3 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 25 Sep 2023; AzTrials last refreshed its copy on 8 Nov 2026.