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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-01

Study Completion Date

2023-06-16

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

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Detailed Description

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Conditions

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NASH - Nonalcoholic Steatohepatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ALG-055009

Oral dose(s) of ALG-055009 in Healthy Volunteer or subjects with mild hyperlipidemia once daily up to 14 days

Group Type EXPERIMENTAL

ALG-055009

Intervention Type DRUG

Single or multiple doses of ALG-055009

Placebo

Oral dose(s) of placebo in Healthy Volunteer or subjects with mild hyperlipidemia once daily up to 14 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Single or multiple doses of Placebo

Interventions

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ALG-055009

Single or multiple doses of ALG-055009

Intervention Type DRUG

Placebo

Single or multiple doses of Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Male and Female between 18 and 55 years old
2. BMI 18.0 to 32.0 kg/m\^2

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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes