A Study of ALG-055009 in Healthy Volunteers and Subjects With Hyperlipidemia

NASH - Nonalcoholic Steatohepatitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05090111
• Other study ID #: ALG-055009-301
• Status: Completed
• Phase: Phase 1
• Start date: December 1, 2021
• Est. completion date: June 16, 2023

Study information

• Verified date: September 2023
• Source: Aligos Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: June 16, 2023
• Est. primary completion date: June 16, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria for Healthy Subjects:

1. Male and Female between 18 and 55 years old

2. BMI 18.0 to 32.0 kg/m^2

Inclusion Criteria for Subjects with Mild Hyperlipidemia:

1. Male and Female between 18 and 65 years old

2. BMI 18.0 to 35.0 kg/m^2

3. 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

Exclusion Criteria for All Subjects:

1. 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

2. Subjects with Hepatitis A, B, C or HIV-1/HIV-2 infection or acute infections such as SARS- CoV-2 infection

3. 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)

4. Subjects with history of thyroid disorder or abnormal thyroid function tests at screening or known sensitivity to thyroid medications

5. Subjects receiving, or urgently requiring, any lipid lowering therapy

Related Conditions & MeSH terms

• Fatty Liver
• Hyperlipidemias
• Hyperlipoproteinemias
• NASH - Nonalcoholic Steatohepatitis
• Non-alcoholic Fatty Liver Disease

Intervention

Drug:
• ALG-055009
Single or multiple doses of ALG-055009
• Placebo
Single or multiple doses of Placebo

Locations

Country	Name	City	State
France	Biotrial	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Aligos Therapeutics

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1	Up to 14 days for Part 1
Primary	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1	Up to 28 days for Part 2
Primary	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1	Up to 35 days for Part 3
Secondary	Maximum Plasma Concentration [Cmax]	Pharmacokinetic parameters of ALG-055009 in plasma	Predose (between -0.25 hours and 0 hours) up to 35 Days
Secondary	Area under the concentration time curve [AUC]	Pharmacokinetic parameters of ALG-055009 in plasma	Predose (between -0.25 hours and 0 hours) up to 35 Days
Secondary	Time to maximum plasma concentration [Tmax]	Pharmacokinetic parameters of ALG-055009 in plasma	Predose (between -0.25 hours and 0 hours) up to 35 Days
Secondary	Half-life [t1/2]	Pharmacokinetic parameters of ALG-055009 in plasma	Predose (between -0.25 hours and 0 hours) up to 35 Days
Secondary	Minimum Plasma Concentration [Cmin]	Pharmacokinetic parameters of ALG-055009 in plasma	Predose (between -0.25 hours and 0 hours) up to 35 Days
Secondary	Change in lipid / lipoprotein levels from baseline through Day 28 in Multiple Dose in Subjects with Mild Hyperlipidemia		Screening, Day -1 to Day 28