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

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

Study Overview

• Status: Completed
• Conditions: NASH - Nonalcoholic Steatohepatitis
• Intervention / Treatment: Drug: Placebo; Drug: ALG-055009

• Study Type: Interventional
• Enrollment (Actual): 98
• Phase: Phase 1

Contacts and Locations

Study Locations

• France
  • Rennes, France
    • Biotrial

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ALG-055009; Oral dose(s) of ALG-055009 in Healthy Volunteer or subjects with mild hyperlipidemia once daily up to 14 days	Drug: ALG-055009; Single or multiple doses of ALG-055009
Placebo Comparator: Placebo; Oral dose(s) of placebo in Healthy Volunteer or subjects with mild hyperlipidemia once daily up to 14 days	Drug: Placebo; Single or multiple doses of Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Plasma Concentration [Cmax]	Pharmacokinetic parameters of ALG-055009 in plasma	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	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	Predose (between -0.25 hours and 0 hours) up to 35 Days
Half-life [t1/2]	Pharmacokinetic parameters of ALG-055009 in plasma	Predose (between -0.25 hours and 0 hours) up to 35 Days
Minimum Plasma Concentration [Cmin]	Pharmacokinetic parameters of ALG-055009 in plasma	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		Screening, Day -1 to Day 28

Collaborators and Investigators

• Sponsor: Aligos Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): June 16, 2023
• Study Completion (Actual): June 16, 2023

Study Registration Dates

• First Submitted: October 11, 2021
• First Submitted That Met QC Criteria: October 11, 2021
• First Posted (Actual): October 22, 2021

Study Record Updates

• Last Update Posted (Actual): September 25, 2023
• Last Update Submitted That Met QC Criteria: September 21, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Metabolic Diseases; Liver Diseases; Lipid Metabolism Disorders; Dyslipidemias; Fatty Liver; Non-alcoholic Fatty Liver Disease; Hyperlipidemias; Hyperlipoproteinemias
• Other Study ID Numbers: ALG-055009-301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No