CompletedPhase 1

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

France98 participantsStarted 2021-12-01

Plain-language 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

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Timeframe: Up to 14 days for Part 1

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Timeframe: Up to 28 days for Part 2

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Timeframe: Up to 35 days for Part 3

Trial details

NCT IDNCT05090111

SponsorAligos Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-06-16

View on ClinicalTrials.gov More NASH - Nonalcoholic Steatohepatitis trials

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Timeframe: Up to 14 days for Part 1

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Timeframe: Up to 28 days for Part 2

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Timeframe: Up to 35 days for Part 3