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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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NASH - Nonalcoholic Steatohepatitis

Intervention / Treatment
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* Drug: ALG-055009
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for Healthy Subjects: Male and Female between 18 and 55 years old BMI 18.0 to 32.0 kg/m^2 Inclusion Criteria for Subjects with Mild Hyperlipidemia: 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 Exclusion Criteria for All Subjects: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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 |